News

Human Milk-Based Nutrition Touches the Lives of 100,000 Premature and Critically Ill Infants

NOV 17 2023

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, proudly commemorates Prematurity Awareness Month 2023 by announcing a significant milestone: more than 100,000 preterm and critically ill infants' lives have been touched by Prolacta's Exclusive Human Milk Diet (EHMD) in hospitals worldwide. "Prematurity Awareness Month is an important time to raise awareness about the challenges and triumphs faced by premature and critically ill infants, as well as their families," said Melinda Elliott, MD, chief medical officer of Prolacta and a practicing neonatologist. "We're proud that for more than two decades, Prolacta's 100% human milk-based nutritional products have supported hospitals on the forefront of progressive care to help so many fragile infants in need." Back in 2013, Delvin and Brandi Peeks from Virginia experienced an emotional NICU journey after the birth of their daughter, Leah Michelle, who was born at 23 weeks weighing just 1 lb 8 oz. Leah Michelle experienced intolerance to the cow milk-based fortifier she initially received and subsequently developed necrotizing enterocolitis (NEC), the most common and serious intestinal disease among premature infants and one of the leading causes of preterm mortality. The Peeks advocated for Leah Michelle to be on an EHMD and asked the hospital to fortify Brandi's breast milk with a Prolacta fortifier. Today, Leah Michelle is a thriving 9-year-old who is considered everyone's best friend at school and enjoys playing the clarinet, acting, and singing. She's also on a competitive swim team and won her first race this past summer. Available since 2006, Prolacta's human milk-based fortifiers have transformed the standard of care in hospitals worldwide by offering a proven alternative to cow milk-based fortifiers. All types of hospitals have seen the benefits of an EHMD to treat the critically ill, premature infants in their care, including those supporting underserved populations. Recognizing that the preterm birth rate is highest among people of color and that prematurity is the leading cause of death among Black infants,5 hospitals are working to bridge healthcare disparities by making Prolacta's EHMD more accessible to disadvantaged families. One example is Los Angeles General Medical Center (formerly LAC+USC Medical Center), among the largest public hospitals in the U.S. This safety-net hospital implemented Prolacta's EHMD and witnessed less NEC, less bronchopulmonary dysplasia (BPD), less cases of severe retinopathy of prematurity (ROP), and shorter lengths of stay among its premature infants while achieving net savings of $2.7 million over a two-year period. "We have shown substantial reductions in mortality and long-term morbidity that benefits infants especially at high risk, including those born to mothers of substantial social risk, lower socioeconomic status, and lack of access to prenatal care," said Dr Rangasamy Ramanathan, professor of pediatrics and division chief of the Division of Neonatal Medicine at Los Angeles General Medical Center. The clinical benefits and cost savings of an EHMD are reinforced by a recent peer-reviewed report that showed Prolacta's human milk-based fortifiers reduced comorbidities among preterm infants while saving hospitals up to $3.4 million annually.

Pregnancy in Rheumatic Disease Quadruples Risk of Cardiovascular Events

NOV 16 2023

Pregnant individuals with autoimmune rheumatic diseases (ARDs) are at least four times more likely to experience an acute cardiovascular event (CVE) than are pregnant individuals without these conditions, according to new research presented at the American College of Rheumatology (ACR) 2023 Annual Meeting. Pregnant individuals with primary antiphospholipid syndrome (APS) had a 15-fold increase in CVE risk. Patients who experienced CVEs were also more likely to experience preterm birth and other adverse pregnancy outcomes (APOs). Rashmi Dhital, MD, a rheumatology fellow at the University of California, San Diego, and colleagues examined the medical records of pregnant individuals in California who had delivered singleton live-born infants from 2005 to 2020. Using data from the Study of Outcomes in Mothers and Infants (SOMI) database, an administrative population-based birth cohort in California, they identified more than 7 million individuals, 19,340 with ARDs and 7758 with APS. They then analyzed how many patients experienced an acute CVE during pregnancy and up to 6 weeks after giving birth. CVEs occurred in 2.0% of patients with ARDs, 6.9% of individuals with APS, and 0.4% of women without these conditions. CVE risk was four times higher in the ARDs group (adjusted relative risk [aRR], 4.1; 95% CI, 3.7 - 4.5) and nearly 15 times higher in the APS group (aRR, 14.7; 95% CI, 13.5 - 16.0) than in the comparison group. Patients with systemic lupus erythematosus (SLE) had a sixfold higher risk of CVE, which was further exacerbated by concomitant APS (18-fold higher risk) or lupus nephritis (15-fold higher risk). Dhital also classified CVEs as either venous thromboembolism (VTE) and non-VTE events. Pregnant patients with APS had a high risk for VTE-only CVE (40-fold greater) and a 3.7-fold higher risk of non-VTE events, compared with pregnant patients without these conditions. Patients with SLE along with lupus nephritis had a 20-fold increased risk of VTE-only CVE and an 11-fold higher risk of non-VTE CVE. Although the study grouped rheumatic diseases together, "lupus is generally driving these results," Sharon Kolasinski, MD, of the University of Pennsylvania in Philadelphia noted. She moderated the plenary session where the research was presented. "If you take out lupus, then what is the risk? That would be an interesting question." Between 25% to 30% of all CVEs occurred in the postpartum period, highlighting the importance of close monitoring of cardiovascular risks and events in women with ARDs or APS both during pregnancy and postpartum, Dhital noted. Recognizing these risks "can sometimes be challenging due to a lower suspicion of CVE in younger patients, and also symptoms overlap with normal pregnancy," Dhital said during her plenary presentation. Working with other clinical teams could help physicians detect these risks in patients, she noted.

A Dozen Genes Found Dangerous in Pregnancy

OCT 30 2023

Approximately 1 in 40 women are carriers of single gene disorders that could manifest as pregnancy complications, based on data from more than 90,000 individuals. Single gene disorders remain a leading cause of morbidity and mortality in newborns and children, but carrier screening for such disorders was limited until recent advances in DNA sequencing, wrote Vivienne Souter, MD, of Natera in Austin, Tex., and colleagues. Identifying single gene disorders in carrier screening also includes the discovery of genetic variants that could affect the carrier parent during pregnancy, they said. In a study published in Obstetrics and Gynecology, the researchers reviewed data from 91,637 female patients who underwent testing via a 274-gene carrier screening panel. The median age of the participants was 32.8 years, and approximately half were pregnant at the time of the testing. Based on previously published reports, the researchers identified 12 genes with potential for carrier manifestations during pregnancy; of these, 9 had manifestations whether or not the fetus was affected by the genetic condition (ABCB11, COL4A3, COL4A4, COL4A5, DMD, F9, F11, GLA, and OTC) and 3 had manifestations only if the fetus was affected by the condition (CPT1A, CYP19A1, and HADHA). Overall, 66% of the tests were positive for at least one of the 274 genes; the frequency of potentially pathogenic variants for the 12 genes that could manifest as complications during pregnancy ranged from 1 in 117 individuals for the F11 gene to 1 in 8,331 for the OTC gene. A total of 2.3% of the participant tests were associated a pathogenic or likely pathogenic variant in at least 1 of the 12 genes, which accounted for 3.5% of all positive samples, and 2.0% were identified as carriers for 1 of the 9 genes that could affect women during pregnancy regardless of fetal genetic status. "People of Ashkenazi Jewish heritage were over-represented in the carrier group, representing 6.0% of carriers but only 1.9% of the entire study cohort," the researchers noted. Manifestations related to the 12 genes included cardiomyopathy, hemorrhage, gestational hypertensive disorders, cholestasis of pregnancy, acute fatty liver, hyperammonemic crisis, and maternal virilization. "The reported incidence of pregnancy complications in carriers ranged from 10% to 62% depending on the gene involved, but information was limited for most of the conditions," and published literature identified management recommendations for 11 of the 12 genes, the researchers wrote. The findings were limited by several factors including the use of cases received by the laboratory, which might have yielded more women with above-average risk because of family history, the researchers noted. Other limitations included a lack of data on further evaluation or counseling after the screening, and the lack of separation of the results according to the specific variant, they said. Also, the study population was limited to those who had access to carrier screening, and may not be generalizable to the population at large.

Early-Onset MASLD Risk Higher in Low-Birth-Weight Babies

OCT 30 2023

Babies with low birth weight or those who are small for gestational age (SGA) have a sixfold increased relative risk for progressive liver disease at an early age, a nationwide Swedish study finds. The study aimed to associate birth anthropometrics (birth weight, gestational age, and birth weight for gestational age) with MASLD (metabolic dysfunction-associated steatotic liver disease, formerly known as NAFLD) and progressive liver disease in children and young people. The Swedish nationwide ESPRESSO longitudinal cohort database (medical registries) was linked to the Swedish Medical Birth Register (maternal, birth, and infant factors). In all, 165 biopsy-proven MASLD in people aged < 25 years matched to 717 controls in the general population were identified and analyzed.

COVID Shot While Pregnant Limits Severe Cases in Infants Says CDC

OCT 30 2023

Getting a COVID-19 vaccine during pregnancy significantly reduces the chance that a baby will be hospitalized for COVID-19, new data shows. The study from the CDC found that vaccines were 54% effective at protecting infants from COVID-19 hospitalization in the first 3 months of life, and 35% effective at protecting babies from ages 3 months through 5 months old. Infants can be vaccinated against COVID-19 starting at 6 months old. Infants who were hospitalized with COVID-19 whose mothers were unvaccinated were more likely to need help breathing, compared to infants whose mothers had been vaccinated. For the study, researchers analyzed data for 716 babies hospitalized between March 2022 and May 2023. Among the babies in the study, 377 were hospitalized with COVID-19. Mothers were considered vaccinated if they’d had at least two COVID vaccines, one of which was given during pregnancy. All other mothers of babies in the study were unvaccinated. Vaccinated mothers pass antibodies against COVID-19 through the placenta to the fetus. The authors noted that a limitation of the study was that prior infection of mothers was not analyzed, including among unvaccinated mothers. They also said it is possible that “infection-induced antibodies could provide some protection against infant COVID-19–related hospitalization.” “Maternal vaccination during pregnancy provides some protection against COVID-19–related hospitalizations among infants, particularly those aged less than 3 months,” the authors wrote. “Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19.”

'No Measurable Change' in Global Preterm Birth Rates

OCT 30 2023

Across the world, preterm birth is one of the main risk factors for neonatal mortality among children younger than 5 years. Yet according to a new study, the international community has made few strides over the past decade when it comes to reducing the rates of preterm births and recording the related routine data.

 

"There has been no measurable change in preterm birth rates over the past decade at global level," according to the authors. "Despite increasing facility birth rates and substantial focus on routine health data systems, there remain many missed opportunities to improve preterm birth data." The study, published in The Lancet, was funded by the Children's Investment Fund Foundation through grants awarded to the London School of Hygiene and Tropical Medicine, the United Nations Children's Fund, and the World Health Organization (WHO). Building on the WHO's last update on the topic, which was published in 2015, the researchers conducted an analysis that included 679 data points (222 million births) from January 1, 2010, to December 31, 2020, from 103 countries and areas. They pointed out that global data on preterm births must be systematically updated so that suitable public policies can be designed and implemented. Preterm birth rates were estimated by using a hierarchical Bayesian framework that accounted for data quality differences. As the results show, preterm birth is not just a concern in low- and middle-income countries. Indeed, rates of 10% or higher occur in high-income countries, such as Greece and the United States. The situation, however, is worse in places with fewer resources. Around 65% of preterm births in 2020 occurred in sub-Saharan Africa and southern Asia. The highest preterm birth rates were in Bangladesh (16.2%), Malawi (14.5%), and Pakistan (14.4%), whereas the lowest were in Serbia (3.8%), the Republic of Moldova (4%), and Kazakhstan (4.7%). Although Brazil's rate, 11.1%, is above the overall average, its average annual rate of reduction between 2010 and 2020 was 0.7%. Among those who have commented on the study is Anshu Banerjee, MD, PhD, director of the WHO Department of Maternal, Newborn, Child and Adolescent Health and Aging. He called for the adoption of strong and decisive measures to turn the situation around. "These numbers show an urgent need for serious investment in services available to support [preterm babies] and their families, as well as a greater focus on prevention — in particular, ensuring access to quality healthcare before and during every pregnancy." "Countries need to prioritize programmatic investments to prevent preterm birth and to ensure evidence-based quality care when preterm birth occurs," wrote the study authors. "Investments in improving data quality are crucial so that preterm birth data can be improved and used for action and accountability processes."

Ultrasonic Irradiation and Fetal Damage: Researcher Explores Possible Link

OCT 30 2023

In her compelling book, The Dark Side of Prenatal Ultrasound, researcher and birth advocate Jeanice Barcelo offers “a ground-breaking analysis of the documented facts concerning the dangers of prenatal ultrasound.” She states, “Despite the medical establishment repeating the mantra that ultrasound is ‘just sound waves’ and therefore ‘perfectly safe’ during pregnancy, in truth, ultrasound is based on non-ionizing radiation, and many thousands of studies have confirmed that this type of radiation is harmful, especially for children and developing babies in the womb.” In her book, Barcelo includes nearly 300 pages of sourced material and more than 1,800 citations to back up her findings that ultrasound is causing harm to developing babies.  Barcelo asserts that ultrasound “should be banned from obstetrics immediately.” “What I found out through my research is that ultrasound IS radiation,” she said, “and I can very clearly state to you that the Food and Drug Administration has known for many, many decades about the harm this technology is causing.” Among the risks Barcelo cites that can be attributed to ultrasound exposure in utero are: radiation-induced genetic mutations that can negatively affect future generations; damaging reproductive effects that can lead to fertility issues and sterility later in life; radiation-induced brain damage and/or neurodevelopmental delays that can contribute to autism; and many childhood diseases.  “Our children have never, ever been this diseased and this sick,” Barcelo said. “One in six children in the United States is neurodevelopmentally disabled — one in six children! One in 30 children is autistic. And when did autism start? In the 1970s, when they started using ultrasound, mainstreaming it into obstetrical care.” Barcelo’s goal is to encourage parents and those who want to become parents to fully understand the facts — and the potential risks — of ultrasound technology, fetal heartrate monitors and other devices that make use of non-ionizing radiation.“The book contains life-altering information that could save the lives of many children,” Barcelo added. “It is time to take a stand to protect the children.”

Death Rate Rises in Babies

OCT 30 2023

For the first time in two decades, the infant mortality rate in the United States is up, rising 3 percent between 2021 and 2022. The data comes from a new provisional report by the Centers for Disease Control and Prevention’s National Center for Health Statistics, which says that last year, 20,538 babies across the U.S. died before reaching their first birthday. The number is a worrisome indicator about the state of maternal health care in one of the most developed countries in the world. “In a country as well-resourced as the U.S., with as much medical technology and so on, we shouldn’t have babies dying in the first year of life,” Arjumand Siddiqi, a University of Toronto professor who studies population health, told the Wall Street Journal. “That should be super rare, and it’s not.” The report found that there were 5.6 infant deaths per 1,000 lve births, up from 5.44 in 2021. While that degree of growth seems small, Danielle Ely, the lead researcher on the report, told the Associated Press that it’s the “first statistically significant jump” since the 2001-2002 data period.

Company Signs Contract for Device

OCT 16 2023

Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company focused on harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd.), announced that the LungFit PH system has received an Innovative Technology contract from Vizient, Inc., the nation’s largest provider-driven health care performance improvement company. The contract was awarded based on the recommendation of the LungFit PH system by hospital experts who serve on one of Vizient’s customer-led councils, and it signifies to Vizient customers unique qualities that potentially bring improvement to the health care industry. Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient’s Innovative Technology Program. Vizient customer-led councils identify technologies that have the potential to enhance clinical care, patient safety, health care worker safety or improve business operations of health care organizations. Approved in June 2022, LungFit PH is the first and only 3-in-1 integrated system for inhaled nitric oxide (iNO) generation, delivery, and monitoring, providing unlimited on-demand iNO regardless of set dose or ventilator flow. LungFit PH employs patented Ionizer™ technology to generate iNO from room air within seconds, providing unprecedented speed to care. This point-of-care solution alleviates the logistical and supply challenges associated with traditional iNO systems by streamlining inventory management with a predictable, on-demand supply of iNO generated at the bedside. Clinicians generate what they need whenever they need it. This innovative system is paired with an all-inclusive 24/7 service and support program designed to exceed customer expectations.

“We’re very happy and honored to be awarded an Innovative Technology contract from Vizient for our LungFit device. This validates the customer experience and feedback we have received to date,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Our revolutionary generator-based delivery system is a transformative technology with the potential to change how nitric oxide is used to the benefit of both patients and hospitals, and we are very excited by this opportunity to expand our reach through the robust Vizient customer network.” “Congratulations to Beyond Air for being awarded an Innovative Technology contract,” said Kelly Flaharty, senior director of contract services for Vizient. “Our member council recommended the LungFit PH system for this contract based on the efficiencies it offers and its potential to make an incremental difference in health care.” Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents more than $130 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with hospital experts on its customer-led councils and task forces to evaluate products for their potential to bring real innovation to health care. Vizient may award a contract to products deemed worthy of the Innovative Technology designation outside of the competitive bid cycle.

COVID Shot While Pregnant Limits Severe Cases in Infants Says CDC

OCT 13 2023

Getting a COVID-19 vaccine during pregnancy significantly reduces the chance that a baby will be hospitalized for COVID-19, new data shows. The study from the CDC found that vaccines were 54% effective at protecting infants from COVID-19 hospitalization in the first 3 months of life, and 35% effective at protecting babies from ages 3 months through 5 months old. Infants can be vaccinated against COVID-19 starting at 6 months old. Infants who were hospitalized with COVID-19 whose mothers were unvaccinated were more likely to need help breathing, compared to infants whose mothers had been vaccinated. For the study, researchers analyzed data for 716 babies hospitalized between March 2022 and May 2023. Among the babies in the study, 377 were hospitalized with COVID-19. Mothers were considered vaccinated if they’d had at least two COVID vaccines, one of which was given during pregnancy. All other mothers of babies in the study were unvaccinated. Vaccinated mothers pass antibodies against COVID-19 through the placenta to the fetus. The authors noted that a limitation of the study was that prior infection of mothers was not analyzed, including among unvaccinated mothers. They also said it is possible that “infection-induced antibodies could provide some protection against infant COVID-19–related hospitalization.” “Maternal vaccination during pregnancy provides some protection against COVID-19–related hospitalizations among infants, particularly those aged less than 3 months,” the authors wrote. “Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19.”

PyrAmes Receives FDA Clearance for Boppli Wearable Blood Pressure Monitoring Device

OCT 4 2023

PyrAmes Inc., a digital health company pioneering innovative blood pressure (BP) monitoring solutions, today announced it has received FDA 510(k) clearance for its revolutionary Boppli platform to continuously and non-invasively monitor the blood pressure of critically-ill infants. Boppli offers safe and accurate BP monitoring as an alternative to invasive arterial lines (IAL) and intermittent cuff-based measurements. Boppli previously received Breakthrough Device Designation from the FDA, recognizing its potential to enable more timely identification of life-threatening conditions. It is the only commercially-available, continuous and non-invasive BP monitoring solution for infants. Boppli improves ease of use and avoids the risks and costs associated with IALs. Boppli also eliminates the cumbersome and time-consuming nature of standard cuff-based measurements, which provide only occasional spot BP values and may be prone to inaccuracies. Boppli accuracy was demonstrated to be within FDA guidelines during a rigorous, pivotal clinical study by comparing Boppli sensor data against simultaneous IAL data for critically ill infants in multiple neonatal intensive care units (NICU) in the US and Canada. “Boppli will provide us with the ability to non-invasively and continuously monitor blood pressure in our tiny, fragile babies – accurately and without disturbing them,“ said Lamia Soghier, MD, MEd, MBA, Medical Director and Quality & Safety Officer of the NICU at Children’s National Hospital. “This is a game-changer, as we no longer have to worry about spending time sticking infants multiple times in multiple places to put in an arterial line. I am also excited that we will avoid arterial line complications. As a clinician who has seen terrible loss of fingers from thrombosis of arterial lines, I am thrilled that we now have a safer modality. We will be able to place Boppli quickly, even for our tiny 500g infants. As one of the centers in PyrAmes’ clinical study, we saw first-hand the value that Boppli provided to medical care in the NICU.” Boppli integrates capacitive sensors that are placed on the arm and/or leg of infants to acquire pulse waveform measurements. The systolic, diastolic, and mean arterial pressures are then inferred from the recorded pulse waveform data using algorithms trained with artificial neural network techniques. “We are excited to have Boppli, our company’s first product, cleared by the FDA,” said Xina Quan, Ph.D., PyrAmes Co-founder and CEO. “Detecting clinically-important blood pressure information in a safe and timely way with a non-invasive approach has the potential to provide life-changing clinical information for hundreds of thousands of fragile babies without the risks and costs of today’s standards of care.” “As PyrAmes' commercial partner, we are excited to introduce these innovative products, empowering NICU doctors and nurses with Boppli's first-of-its kind Non-Invasive Blood Pressure technology," stated Bob Cormier, President of Sentec North America. "Boppli addresses a crucial need in non-invasive monitoring for neonatal patients, potentially transforming the well-being of these delicate, precious patients." Boppli’s FDA market clearance represents a first step in PyrAmes’ robust product roadmap to enable more convenient, clinically-accurate, blood pressure monitoring for inpatients and outpatients of all ages, beginning with babies and their mothers to support their health before and after childbirth.

Minimally Invasive Surfactant Shows Some Benefit in Infants' First 2 Years

OCT 2 2023

Minimally invasive surfactant therapy (MIST) had mixed results in a 2-year follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome who were supported with continuous positive airway pressure (CPAP). Results of the OPTIMIST follow-up study were published online in JAMA. Researchers, led by Peter A. Dargaville, MD, department of paediatrics, Royal Hobart (Australia) Hospital, found that MIST, which involves administering surfactant via a thin catheter, compared with sham treatment, did not reduce the incidence of death or neurodevelopmental disability (NDD) by 2 years of age. However, infants who received MIST had lower rates of poor respiratory outcomes during those first 2 years of life. The study was conducted in 33 tertiary neonatal intensive care units (NICUs) in 11 countries, including Australia, Canada, Israel, New Zealand, Qatar, Singapore, Slovenia, the Netherlands, Turkey, the United Kingdom, and the United States. It included 486 infants 25-28 weeks old supported with CPAP; 453 had follow-up data available and data on the key secondary outcome were available for 434 infants. The sham treatment consisted of only transient repositioning without airway instruments. Treating clinicians, outcome assessors, and parents were blinded to group status.

Minimally Invasive Surfactant Shows Some Benefit in Infants' First 2 Years

SEP 15 2023

Minimally invasive surfactant therapy (MIST) had mixed results in a 2-year follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome who were supported with continuous positive airway pressure (CPAP). Results of the OPTIMIST follow-up study were published online in JAMA. Researchers, led by Peter A. Dargaville, MD, department of paediatrics, Royal Hobart (Australia) Hospital, found that MIST, which involves administering surfactant via a thin catheter, compared with sham treatment, did not reduce the incidence of death or neurodevelopmental disability (NDD) by 2 years of age. However, infants who received MIST had lower rates of poor respiratory outcomes during those first 2 years of life. The study was conducted in 33 tertiary neonatal intensive care units (NICUs) in 11 countries, including Australia, Canada, Israel, New Zealand, Qatar, Singapore, Slovenia, the Netherlands, Turkey, the United Kingdom, and the United States. It included 486 infants 25-28 weeks old supported with CPAP; 453 had follow-up data available and data on the key secondary outcome were available for 434 infants.The sham treatment consisted of only transient repositioning without airway instruments. Treating clinicians, outcome assessors, and parents were blinded to group status. Death or NDD occurred in 36.3% of the patients in the MIST group and 36.1% in the control group (risk difference, 0%; 95% confidence interval, −7.6% to 7.7%; relative risk, 1.0; 95% confidence interval, 0.81-1.24). Hospitalization with respiratory illness occurred in 25.1% in the MIST group versus 38.2% in the control group (RR, 0.66; 95% CI, 0.54-0.81). Parent-reported wheezing or breathing difficulty occurred in 40.6% in the MIST group versus 53.6% in controls (RR, 0.76; 95% CI, 0.63-0.90). Asthma diagnosed by a physician was reported in 4.4% and 11.9% of MIST and control-group infants, respectively. Reported use of inhaled relievers (beta2 agonists) was 23.9% in the MIST group versus 38.7% in controls.

Is Society Ready for an Artificial Womb?

SEP 13 2023

Food and Drug Administration regulators are set to review how scientists should conduct the first human tests of bag-like wombs, meant to nurture babies born so premature that modern medicine struggles to keep them healthy. The agency plans to meet with outside advisers and discuss behind closed doors what the agency called “confidential commercial information,” citing a federal law that allows non-public meetings to discuss trade secrets. The agency hasn’t disclosed which company’s work will be discussed. Philadelphia-based Vitara Biomedical has said that it is working on an artificial womb and is close to human clinical trials. A company executive said at a biotech symposium last year that the firm is commercializing the research of one of two U.S. groups known to be testing the technology on lambs. The other U.S. group says it is still a few years off from human trials. Vitara’s artificial womb looks like a plastic bag with connected tubes—some to deliver fresh amniotic fluid and others to provide oxygen and medications to the fetus through its umbilical blood vessels, according to published research. Scientists have said they aim for it to nurture premature babies born at 23 to 25 weeks of gestational age, allowing their lungs to develop at least several more weeks in the fluid environment so helpful to their growth. Underdeveloped lungs are the largest problem very premature babies face, neonatologists say, and the best current treatment—putting the tiny patients on ventilators — can cause severe damage. Any tests on human babies would need signoff from the FDA, and the agency often meets with outside advisers before high-profile decisions. Tests would require approval from a committee charged with protecting humans in scientific tests, known as an institutional review board.

Study Links Preterm Births to Mother's Poor Mental Health

AUG 30 2023

Women with mental health issues are 50% more likely to give birth to a premature baby, according to a new study of 2 million pregnancies in England. Researchers said about 1 in 10 women who had used mental health services had a preterm birth, while 1 in 15 who did not use mental health services had a preterm birth. The research, published in The Lancet Psychiatry, found a connection between the severity of mental health challenges and unwanted outcomes at birth. Women who had been in a psychiatric hospital were almost two times as likely to have a premature birth, compared to those who had no contact with mental health services. Women with a history of mental health issues were also more likely to give birth to a baby that was small for its gestational age, The Guardian reported – specifically, 75 per 1,000 births, compared with 56 per 1,000 births. Researchers said pregnant women should receive mental health assessments as soon as possible. That could reduce the number of maternal deaths, stillbirths, premature births, and underweight babies, Louise Howard, PhD, a professor of women's mental health at King’s College London, told The Guardian.

No Reduction in Cerebral Palsy With Later Prenatal Magnesium

AUG 30 2023

Giving intravenous magnesium sulfate to pregnant women at risk of preterm birth at 30 to 34 weeks' gestation did not improve the primary endpoint of death or cerebral palsy in their offspring at 2 years of age, new research shows, although the study had limited power to detect small between-group differences.Previous evidence has shown that administering magnesium sulfate to pregnant women at less than 30 weeks' gestation improves the chance their infant will survive without cerebral palsy, and guidelines recommend this intervention, but there's a lack of consensus regarding the optimal gestational age for its use. The multisite MAGENTA trial included 1433 pregnant women at risk of preterm birth for whom delivery was anticipated or was planned to occur within 24 hours. The mean age of the cohort was 30.6 years. The women were randomly assigned to receive magnesium sulfate (4 g) or placebo intravenously at 30–34 weeks' gestation. Surviving children were assessed by a pediatrician as soon as possible to the children's turning 2 years of age. The assessment included a neurologic examination to diagnose cerebral palsy, defined as loss of motor function and abnormalities of muscle tone and power.

Healthy Babies Can Still Get Very Sick From RSV

AUG 30 2023

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease. The researchers said the results reinforce the importance of a new preventive shot that can lower the risk for severe RSV infection in babies. "RSV is the number one cause of hospitalizations in young infants," said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tennessee, and the lead author of the new study. But "the vast majority of kids didn’t have underlying medical conditions" when they got sick. Every infant in the study was in an intensive care unit for at least 24 hours, Halasa said, putting both an emotional and logistical strain on parents who now had to figure out how to maintain work commitments and continue to care for any other children in the family. And most babies gave no prior indication that RSV would affect them so profoundly. "Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life," added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia. Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring. In July, the Food and Drug Administration (FDA) approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

Preterm Birth Rates Higher in Black Patients

AUG 30 2023

Non-Hispanic Black individuals have a significantly higher rate of preterm births than non-Hispanic Whites, according to a study published in American Journal of Preventive Medicine. The study included 509,890 live births among non-Hispanic Blacks and 1,790,350 live births among non-Hispanic Whites reported to the National Center for Health Statistics (NCHS) in 2019. Demographic risk factors were maternal age and number of births. Prepregnancy cardiovascular risk factors were hypertension, diabetes, BMI, and smoking status. Socioeconomic risk factors were education, private insurance, and receipt of prenatal care.

Etiometry Gains FDA Clearance of AI-Based Algorithm

AUG 9 2023

Etiometry, the leader in clinical decision-support software, announced its IVCO2 Index was cleared by the Food and Drug Administration for use with neonatal ICU patients under 2kg, who are especially vulnerable to the effects of hypercapnia. This is Etiometry’s 9th FDA clearance and its second this year.

Etiometry’s IVCO2 Index is a game changer in critical care, seamlessly integrating multiple data sources to provide an individualized assessment for ventilation-perfusion mismatch and detect the likelihood a patient will have a PaCO2 of greater than 50 mmHg in mechanically ventilated patients. It has been specifically designed to overcome the challenges of existing conventional monitoring, such as arterial blood gas testing and transcutaneous monitoring for tiny premature newborns. “The IVCO2 Index is a first-of-its-kind algorithm that increases the ability to detect hypercapnia risk without needing additional hardware attached to these fragile patients,” said Dimitar Baronov, CTO of Etiometry. “It allows clinicians to prioritize care for patients who need it most.” Many NICU patients require ventilatory support and their conditions can change quickly. Vigilant monitoring for hypercapnia is critical for maximizing neurodevelopmental outcomes and preventing complications. Digital monitoring illuminates the patient’s condition between routine blood gas testing, adding another layer of protection to prevent oversights that may lead to poor outcomes. “Our proprietary algorithm’s accurate and continuous monitoring for hypercapnia will enable the expansion of improved outcomes achieved by Etiometry partners within cardiac ICUs and PICUs into the NICU environment,” said Shane Cooke, CEO of Etiometry.

Neotech Launches Tubing Holder

AUG 2 2023

Neotech Products announced the release of the NeoSnug Tubing Holder. NeoSnug helps prevent tubing from shifting or slipping. The NeoSnug’s unique, pre-cut shape goes under the nose and allows clinicians to secure the tubing close to the nares. Like several Neotech products, NeoSnug features a NeoBond Hydrocolloid base, which is less likely to irritate sensitive skin. The flap is engineered to hold securely and permanently. “Current common practice is to use multiple products to secure the NG tube; applying DuoDERM to the skin, then placing the tube, then laying TegadermT or Hypafix over that,” inventor Carol Herndon, BSN, RNC-NIC, said. “And nurses often hand-cut them to get the shape they need. I wanted a single use, all-in-one solution that was skin friendly, pre-cut, and extremely secure. The design also helps guard against the infant accidentally pulling out the tube.” The NeoSnug features: Skin friendly Hydrocolloid adhesive base; unique shape ideal for securing tubes close to the nares; fold over flap engineered to relieve stress on tubes and keep them securely in place; non-woven fabric contours to face or body; single patient use; and made in the USA.

New AAP Framework Seeks to Help Pediatricians Monitor Premature Babies

JULY 3 2023

A new framework from the American Academy of Pediatrics published aims to aide general pediatricians in better caring for premature babies who are at risk of developing developmental disabilities. About 1 in 10 babies in the United States are born before full term. Even when they are discharged from neonatal intensive care units, these babies are still at risk for conditions like cerebral palsy, autism spectrum disorder, deafness, and severe hearing loss. The framework, published in the journal Pediatrics , consolidates existing research into a guide for busy pediatricians to categorize patients as very high risk, high risk, or moderate-low risk for neurodevelopmental disabilities. The guidance also lists key identifiers to help providers flag issues early, such as asymmetry of hand use. Beth Ellen Davis, MD, MPH, a framework author, said the goal is to help pediatricians determine what surveillance and screening they can conduct to promote positive health outcomes. Davis said she wished she had this guidance on caring for children who were born prematurely during her 10 years as a general pediatrician in the US Army Medical Corps. "I didn't know what I was supposed to do differently with [the former NICU babies]," said Davis, a professor in the Division of Neurodevelopmental Behavioral Pediatrics at the University of Virginia in Charlottesville. For instance, babies born earlier than 28 weeks who have hypoxic ischemic encephalopathy or retinopathy of prematurity (ROP) requiring surgery or intervention are classified as very high risk for the adverse outcomes, including intellectual disability. The authors recommend follow-up and surveillance based on risk level at roughly 9-month intervals until around age 5. Each visit includes assessing for developmental milestones, like walking by 18-months or noting atypical pencil grasp at age 3.

OCD Linked to Adverse Pregnancy and Neonatal Outcomes

JULY 3 2023

Maternal obsessive-compulsive disorder was associated with increased adverse pregnancy, delivery and neonatal outcomes, according to findings from two cohort studies published in JAMA Network Open. “We believe that women with obsessive-compulsive disorder (OCD) would benefit from early referral in pregnancy and having access to regular antenatal care with the obstetric care team and also the physicians that routinely take care of their mental health symptoms,” Lorena Fernández de la Cruz, PhD, principal researcher at the Centre for Psychiatry Research in the department of clinical neuroscience at Karolinska Institutet, Stockholm, told Healio. “Clinicians should work together to reduce these risks, when possible. For example, preeclampsia, for which we observed an increased risk for women with OCD in our study, can be avoided if a good monitoring during pregnancy is in place.” Fernández de la Cruz and colleagues conducted two register-based cohort studies in Sweden and British Columbia, Canada. These studies included all singleton births at 22 weeks or more gestation. The Swedish cohort included births from 1999 to 2019, and the British Columbia cohort included births from April 2000 to December 2019. Researchers examined maternal OCD diagnosis recorded before childbirth and the use of serotonin reuptake inhibitors (SRIs) during pregnancy. Researchers assessed pregnancy and delivery outcomes including gestational diabetes, preeclampsia, maternal infection, antepartum hemorrhage or placental abruption, premature membrane rupture, labor induction, mode of delivery and postpartum hemorrhage. Neonatal outcomes included perinatal death, preterm birth, small for gestational age, low birth weight, low 5-minute Apgar score, neonatal hypoglycemia, neonatal jaundice, neonatal respiratory distress, neonatal infections and congenital malformations. The Swedish cohort included 8,312 pregnancies among women with OCD that were compared with 2,137,348 pregnancies among unexposed women. Overall, 37.2% of women with OCD were taking SRIs in the Swedish cohort, and 81% were taking SRIs in the British Columbia cohort. Women with OCD who took SRIs during pregnancy had increased risks for several pregnancy, delivery and neonatal outcomes compared with women not taking SRIs. Researchers also observed increased risks for these outcomes among women with OCD not taking SRIs compared with women without OCD. According to Fernández de la Cruz, women with OCD and their health care providers should have all available information and assess risks and benefits of treatment while monitoring any pharmacologic treatment changes and, if indicated and available, other therapeutic options, such as cognitive-behavior therapy, should be explored.

New Study Shows Prolacta's Human Milk-Based Nutritional Fortifiers Save Hospital NICUs Up to $3.4M Annually

JUNE 27 2023

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced a peer-reviewed report demonstrating significant annual cost savings that ranged from $500,000 to $3.4 million per hospital after the implementation of Prolacta's Exclusive Human Milk Diet (Prolacta's EHMD) for preterm infants in the neonatal intensive care unit (NICU). NICU leaders from seven US hospitals varying in size, geographic setting, patient population, and funding levels contributed to the publication in BMC Pediatrics titled "Implementing an Exclusive Human Milk Diet for Preterm Infants: Real-World Experience in Diverse NICUs." The study found that of the five hospitals reporting financial data, all realized significant cost avoidance after implementing Prolacta's EHMD, with savings ranging from $515,113 to $3,369,515 per institution annually from a reduction in comorbidities and shorter lengths of stay among very low birth weight (VLBW) infants. Implementation of Prolacta's EHMD resulted in a reduction in the total (medical and surgical) necrotizing enterocolitis (NEC) rate, regardless of the size or level of care of the NICU, as well as reductions in bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), and late-onset sepsis — all common complications of prematurity. VLBW infants fed Prolacta's EHMD also experienced shorter NICU stays at five of the seven hospitals, savings ranging from $307,916 to $2,520,000 per institution annually. The study emphasizes that the cost of Prolacta's EHMD represents a fraction of the usual cost of care for a VLBW infant — approximately $12,500 per infant for an EHMD over a 90-day NICU stay, compared to a total NICU cost of $693,000 to $774,000 for 90 days, depending on level of care. A reduction in length of stay has a sizable impact on total cost expenditure compared with the investment in an EHMD. "This study provides real-world evidence that an EHMD is not only effective in reducing comorbidities in very preterm infants but also saves money regardless of the institution's size or level of care," said lead author Jonathan R. Swanson, MD, MSc, of the University of Virginia Children's Hospital in Charlottesville. Although protocols differed, feeding volume at initiation of fortification, fortification goals, and criteria for transitioning infants off Prolacta's EHMD were similar among the institutions. All seven hospitals fortified between 60-80 mL/kg/day. Clinical outcomes data for each hospital were obtained either from Vermont Oxford Network (VON) or the institution's NICU database. "While the NICUs participating in this study were diverse, the benefits and cost savings of Prolacta's EHMD were consistently observed, including reduced complication rates, shorter lengths of stay, and reduced costs," said Melinda Elliott, MD, chief medical officer for Prolacta and a practicing neonatologist. "These findings mirror the cost savings seen for years in hospitals adopting Prolacta's fortifiers, including my experience and published research on an EHMD at The Herman & Walter Samuelson Children's Hospital at Sinai in Baltimore."

FDA Panel Backs Sanofi-AstraZeneca's Preventive RSV Therapy

JUNE 15 2023

The US Food and Drug Administration advisers have backed the use of Sanofi and partner AstraZeneca's experimental antibody to prevent respiratory syncytial virus (RSV) infections in infants. The advisers voted unanimously in favor of using the antibody, nirsevimab, in newborns and infants to prevent infections in their first RSV season. In a separate 19-2 vote, the panel backed the therapy's use in children aged up to two years who are vulnerable to severe illness through their second RSV season. Swedish Orphan Biovitrum's treatment Synagis is currently the only approved preventive therapy in the United States for high-risk infants against RSV, a leading cause of hospitalizations during an infant's first year of life. Unlike Synagis, which is given as monthly injections, nirsevimab is a long-acting therapy expected to be given once every season to prevent infection regardless of additional medical conditions in infants. "This is probably the closest thing to an RSV vaccine that we have and it really moves the field forward," said panel member Nimish Patel.

Kangaroo Mother Care May Cut Death Risk for Premature Babies by a Third

JUNE 15 2023

Kangaroo mother care (KMC), with close skin-to-skin contact between mothers and their low-birthweight newborns, appears to reduce mortality risk by almost one-third, compared with conventional care, according to new research published online in BMJ Global Health. Starting the contact, which involves mothers carrying the newborn in a sling, within 24 hours of birth and continuing it for at least 8 hours a day both appear to amplify the effect on reducing mortality and infection, the paper states. Sindhu Sivanandan, MD, with the department of neonatology at Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, and Mari Jeeva Sankar, MD, in the pediatrics department of the All India Institute of Medical Sciences, New Delhi, looked at existing studies to compare KMC with conventional care and to compare starting the intervention within 24 hours of birth versus a later start. Their review looked at 31 trials that included 15,559 low-birthweight and preterm infants collectively. Of the 31 trials, 27 studies compared KMC with conventional care and four compared early with late initiation of KMC.

Tankless Delivery System Recognized as a ‘Technological Breakthrough’

JUNE 13 2023

VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced that it will be honored during Premier, Inc.’s annual supplier Innovation Celebration at the 2023 Breakthroughs Conference and Exhibition. VERO Biotech’s GENOSYL Delivery System (DS) will be recognized as a “Technological Breakthrough.” VERO Biotech’sGENOSYL DS – the first tankless nitric oxide delivery system approved by the FDA – will be one of only seven innovations honored during Premier’s supplier Innovation Celebration, which recognizes groundbreaking healthcare technologies that have been launched throughout the year and the ways these products are helping to improve the health of communities. “We are honored to receive this recognition from Premier. We are deeply committed to continued innovation so that we may better serve patients, respiratory therapists, and healthcare providers.” said Brent V. Furse, CEO and President, VERO Biotech. Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,400 US hospitals and 250,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost. GENOSYL DS is the first tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration (FDA). Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension. Unlike tank-based systems, GENOSYL DS generates and delivers iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks, helps to simplify clinical workflow, and streamlines patient care.

Study Shows Prolacta’s Fortifiers Significantly Increase Bioactivity

JUNE 12 2023

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, today announced that Breastfeeding Medicine has published an independent study demonstrating Prolacta's human milk-based fortifiers (HMBF) reinstate and significantly boost bioactive proteins when added to mother's own milk (MOM) and donor human milk (DHM). The naturally occurring bioactive components in human milk are thought to support infants' immunity, development, growth, and long-term health. The study, "Exclusive Human Milk Diet for Extremely Premature Infants: A Novel Fortification Strategy That Enhances the Bioactive Properties of Fresh, Frozen, and Pasteurized Milk Specimens" was an observational feasibility study that analyzed the bioactive components of human milk to evaluate fortification choices. It was authored by Professor Roy K. Philip, MD, MBA, and colleagues of the University of Limerick School of Medicine, and Bernal Institute, University of Limerick, Ireland. "Freshly expressed mother's milk fortified with HMBF appears to be an optimal nutritional choice for extremely premature infants during the critical early postnatal window of tissue accretion and immunological imprinting," Dr Philip said. "Pasteurized donor human milk showed significantly low bioactive properties in comparison to fresh and frozen MOM; however, the addition of HMBF reinstated and further enhanced bioactivity to partially offset the effects of pasteurization." The study found milk samples fortified with Prolacta's HMBF contained higher protein, fat, and total solids (p < 0.05) compared to unfortified samples and those fortified with cow milk-based fortifier (CMBF). HMBF reinstated lactoferrin and α-lactalbumin and exhibited higher protein, fat, and total solids (p < 0.05) in comparison to unfortified specimens and those supplemented with CMBF. Samples with added HMBF had the highest (p < 0.05) antioxidant activity (AA), suggesting the potential capability of HMBF to enhance oxidative scavenging. "This study highlights the advantages of Prolacta's proprietary processing in retaining important bioactive components," said Melinda Elliott, MD, chief medical officer at Prolacta. "The findings underscore that bioactivity matters and may be a key reason why extremely premature infants fed an Exclusive Human Milk Diet (EHMD) with human milk-based fortifiers fare better, have fewer complications, and go home sooner than those fed a cow milk-based diet."

Dietary Fiber Cut Gestational Diabetes, Preterm Birth

MAY 29 2023

Pregnant women who had a high level of insulin resistance according to their triglyceride and glucose (TyG) index prior to 20 weeks' gestation showed improved glucose metabolism, a reduced risk for gestational diabetes, and significantly fewer preterm births when treated daily with an oral fiber supplement for 5 weeks (gestational weeks 20-24) compared with untreated controls in a single-center, randomized study with 295 women. The fiber supplement intervention did not affect lipid profiles or other maternal and neonatal outcomes. Women who develop gestational diabetes are at risk for maternal and perinatal complications and for type 2 diabetes later in life. High TyG index in the first trimester is associated with gestational diabetes development. Improving glucose metabolism in women with a high TyG index during pregnancy might help prevent gestational diabetes. The study randomly assigned 295 women with a TyG index ≥ 8.5 before 20 weeks' gestation seen at the Department of Obstetrics and Gynecology at the Shanghai General Hospital during June 2021 to July 2022. During gestational weeks 20-24, 97 women received a 12-g dose of oral dietary fiber powder twice daily, and 197 served as controls and received usual care without the fiber supplement. All participants received guidance on how to optimize diet and activity. Forty-six women either dropped out or were lost to follow-up prior to delivery. Participants underwent a 75-g oral glucose tolerance test at 25-28 weeks' gestational age and also underwent additional testing.

Global Push to Tackle Maternal and Newborn Deaths Has Stalled, WHO Report Finds

MAY 29 2023

Progress in reducing deaths during pregnancy and childbirth and among newborn infants has stalled since 2015, and over 60 countries are on track to miss 2030 targets at current rates, a World Health Organization report found. The COVID-19 pandemic, poverty, and worsening humanitarian crises have strained already pressured healthcare systems, the U.N. agency said in a statement. Annually since 2015 there have been about 290,000 maternal deaths, 1.9 million stillbirths, and 2.3 million newborn deaths within a month after birth, the report said. The combined total represents one death every seven seconds, "mostly from preventable or treatable causes if proper care was available," the WHO said. Countries need to ramp up investment in primary care to see different results, said Anshu Banerjee, the WHO's director of maternal, newborn, child and adolescent health and ageing. More than 190 countries backed a plan in 2014 to cut rates of stillbirth and preventable deaths among infants, and subsequently set up global targets such as reducing the maternal mortality ratio to less than 70 per 100,000 live births. Projections indicate the need to accelerate progress in order to meet those targets, according to the report, which could help save at least 7.8 million lives by 2030 if they are met. Progress was faster between 2000 and 2010 than at any time since, the report showed, blaming funding shortfalls among the primary reasons. Only 12% of 106 reporting countries have fully-financed maternal and newborn health plans, it said. The report also found that only 61% of reporting countries have systems for keeping track of stillbirths. The report found that 10 countries with the highest maternal deaths, stillbirths and neonatal deaths account for 60% of all such deaths globally. India, Nigeria and Pakistan led that list in 2020, according to the report.

Clinic Responsible for Misdiagnosing Newborn's Meningitis, Must Pay Millions

MAY 29 2023

A health system serving three Midwest states must pay millions to the parents of a now 10-year-old boy whose meningitis was misdiagnosed at birth, according to a report in the Star Tribune, among other news outlets. The story of the jury verdict begins in 2013, when the boy, Johnny Galligan, was just 8 days old. Alarmed by the newborn's crying, lack of appetite, and fever, his parents, Alina and Steve Galligan, brought him to Essentia-Health-Ashland Clinic, located in Memorial Medical Center, in Ashland, Wisconsin. There, the baby was seen by a family physician, who noted the baby's extreme fussiness and irritability and was concerned that he was being overfed. Without ordering additional tests, the family physician sent the baby home but arranged for the Galligans to be visited by a county nurse the following day. In 2020, the Galligans filed a medical malpractice claim against several parties, Duluth Clinic LTD (doing business as Essentia Health and Essentia Health–Ashland Clinic), and Memorial Hospital. In their suit, Johnny's parents alleged that the collective failure to diagnose their son's severe infection led directly to his permanent brain damage.

New Device Launched to Monitor Oxygen Concentration

April 26 2023

Maxtec, a global leading manufacturer of respiratory care products, is excited to announce the launch of its newest device, the MaxO2ME+p. This device is designed to monitor both oxygen concentration and pressure during bubble CPAP therapy, a care method for infants to treat respiratory distress syndrome (RDS) or other respiratory conditions. This device will help provide clinicians with the critical data they need to deliver effective care to their patients. The MaxO2 ME+p is a state-of-the-art device that helps healthcare providers monitor the oxygen concentration and pressure of the air delivered to neonatal patients during bubble CPAP therapy. By providing real-time, accurate data on oxygen concentration and pressure, the MaxO2 ME+p helps healthcare providers ensure that their patients are receiving the correct therapy. "We are thrilled to introduce the MaxO2 ME+p to the market," said Kathy Ouellette, President and CEO of Perma Pure Group (consisting of Maxtec and Perma Pure). "This device is the result of our ongoing commitment to developing innovative medical devices that make a real difference in the lives of patients and healthcare providers. We believe that the MaxO2ME+p is a game-changer in the field, and we are excited to see the impact it will have on patient care." Maxtec is dedicated to providing clinicians with the tools they need to deliver effective care to their patients. The MaxO2 ME+p is the latest example of this commitment, and Maxtec is proud to bring this product to market as they continue to pursue a mission of helping the world to Breathe Easier and Be Healthier.

Noisy Incubators Could Stunt Infant Hearing

April 14 2023

Incubators save the lives of many babies, but new data suggest that the ambient noise associated with the incubator experience could put babies' hearing and language development skills at risk. Previous studies have shown that the neonatal intensive care unit (NICU) is a noisy environment, but specific data on levels of sound inside and outside incubators are limited, wrote Christoph Reuter, MA, a musicology professor at the University of Vienna, Austria, and colleagues. "By the age of 3 years, deficits in language acquisition are detectable in nearly 50% of very preterm infants," and high levels of NICU noise have been cited as possible contributors to this increased risk, the researchers say. In a study published in Frontiers in Pediatrics, the researchers aimed to compare real-life NICU noise with previously reported levels, to describe the sound characteristics, and to identify resonance characteristics inside an incubator. The study was conducted at the Pediatric Simulation Center at the Medical University of Vienna. The researchers placed a simulation mannikin with an ear microphone inside an incubator. They also placed microphones outside the incubator to collect measures of outside noise and activity involved in NICU care. Data regarding sound were collected for 11 environmental noises and 12 incubator handlings using weighted and unweighted decibel levels. Specific environmental noises included starting the incubator engine; environmental noise with incubator off; environmental noise with incubator on; normal conversation; light conversation; laughter; telephone sounds; the infusion pump alarm; the monitor alarm (anomaly); the monitor alarm (emergency)l; and blood pressure measurement. The 12 incubator handling noises included those associated with water flap, water pouring into the incubator, incubator doors opening properly, incubators doors closing properly, incubator doors closing improperly, hatch closing, hatch opening, incubator drawer, neighbor incubator doors closing (1.82 m distance), taking a stethoscope from the incubator wall, putting a stethoscope on the incubator, and suctioning tube. Noise from six levels of respiratory support was also measured.

SARS-CoV-2 Crosses Placenta and Infects Brains of Two Infants: 'This Is a First'

April 14 2023

Researchers have found for the first time that COVID infection has crossed the placenta and caused brain damage in two newborns, according to a study published online today in Pediatrics. One of the infants died at 13 months and the other remained in hospice care at time of manuscript submission. Lead author Merline Benny, MD, with the division of neonatology, department of pediatrics at University of Miami, and colleagues briefed reporters ahead of the release. “This is a first,” said senior author Shahnaz Duara, MD, medical director of the Neonatal Intensive Care Unit at Holtz Children’s Hospital, Miami, explaining it is the first study to confirm cross-placental SARS-CoV-2 transmission leading to brain injury in a newborn. The two infants were admitted in the early days of the pandemic in the Delta wave to the neonatal ICU at Holtz Children’s Hospital at University of Miami/Jackson Memorial Medical Center. Both infants tested negative for the virus at birth, but had significantly elevated SARS-CoV-2 antibodies in their blood, indicating that either antibodies crossed the placenta, or the virus crossed and the immune response was the baby’s. Dr Benny explained that the researchers have seen, to this point, more than 700 mother/infant pairs in whom the mother tested positive for COVID in Jackson hospital. Most who tested positive for COVID were asymptomatic and most of the mothers and infants left the hospital without complications. “However, (these) two babies had a very unusual clinical picture,” Dr Benny said. Those infants were born to mothers who became COVID positive in the second trimester and delivered a few weeks later.

Can Asthma Be Prevented in Children Before Birth?

March 30 2023

Controlling asthma in mothers-to-be, removing dust mites, taking probiotics and vitamin supplements - is there evidence showing that women's behavior during pregnancy could reduce the risk for asthma in their unborn children? At the 27th French-language convention on respiratory medicine, Cécile Chenivesse, MD, of the department of respiratory medicine, immunology, and allergies at Lille Regional University Hospital in France, answered this question. The risk factors of developing asthma differ with age. "During the fetal period, the first risk factor for asthma in unborn children is having asthmatic parents, especially an asthmatic mother," said Chenivesse. "A second important factor is smoking: first, having a mother who smokes during pregnancy, but this also refers to the environment surrounding the pregnant woman, including, but not exclusive to, the father."

Parental asthma, prenatal environmental tobacco smoke, and prematurity (especially in very premature births) are well-established risk factors of childhood asthma. What's more, current results suggest mild-to-moderate causal effects of certain behaviors or modifiable exposure during pregnancy (such as maternal weight gain or obesity, maternal use of antibiotics or paracetamol, and maternal stress); during the perinatal period (such as cesarean birth); or during the postnatal period (such as serious infection with respiratory syncytial virus, excess weight or obesity, exposure to moisture or mold in the home environment and to air pollution outside of it) on childhood asthma. These findings need to be confirmed via interventional studies or at least well-designed prospective studies.

Inhaled Corticosteroids Can controlling a mother's asthma during pregnancy prevent asthma in her baby? "Yes," said Chenivesse. Taking inhaled corticosteroids (ICS) early on and making sure asthma is well controlled during pregnancy (this includes medication other than ICS too) reduces the risk for asthma in the child. "It is logical to assume that exposure to Th2 inflammation during the fetal period could contribute to the risk of developing asthma," Chenivesse added. "A single center, double-blind, randomized, controlled Australian study carried out in 179 women recruited before 22 weeks' gestation confirms that FeNO-guided (fractional exhaled nitric oxide, an eosinophil inflammation marker) asthma treatment during pregnancy reduces the rate of asthma in children between 4 and 6 years of age (140 children; 36% asthmatic). This study already shows the protective effect of inhaled corticosteroids for everyone. They reduce the risk of asthma in the child."

Neonatal Bilirubin Meters Need Better Accuracy

March 30 2023

Despite their convenience and low cost, handheld point-of-care (POC) devices lack precision for measuring neonatal bilirubin and need refinement in order to tailor jaundice management in newborns, a systematic review and meta-analysis reports in JAMA Pediatrics. Lauren E.H. Westenberg, MD, of the division of neonatology at Erasmus MC Sophia Children’s Hospital in Rotterdam, the Netherlands, and colleagues reported that POC meters tended to underestimate neonatal bilirubin levels, compared with conventional laboratory-based quantification.Furthermore, pooled estimates from 10 studies found these devices to be too imprecise overall, with substantial outer-confidence bounds. On the plus side, Dr. Westenberg’s group said POC bilirubin testing was as much as 60 times faster than lab measurement, and used 40-60 times less blood. “Conventional laboratory-based bilirubin quantification usually requires up to 500 mcL, but sometimes even 1,500 mcL, while POC tests require up to 50 mcL, which means less stress for the baby,” Dr Westenberg said. “Especially when infants are cared for at home, it usually takes a few hours between deciding to quantify bilirubin and obtaining the test result. Meanwhile, bilirubin levels may rise unnoticed.” On the positive side, POC devices are useful where laboratories in low-resource areas may be remote, poorly equipped, and not always able to provide an accurate bilirubin level. “As a result, the diagnosis of jaundice relies mainly on visual inspection, which is known to be unreliable,” she said. POC devices, however, need near-perfect conditions for optimal use, and results can be affected by humidity, preanalytic conditions such as test strip saturation, and hematocrit. Yet results from these devices have recently proven to have acceptable accuracy, resulting, for example, in the same clinical decisions as the reference standard in 90.7% of times according to a 2022 study in a hospital in Malawi. Nevertheless, the authors concluded that the devices’ imprecision limits their widespread use in neonatal jaundice management, especially when accurate lab-based bilirubin quantification is available. Results from these POC tests should be interpreted with caution, Dr Westenberg said. In terms of clinical decision-making, POC devices entail a risk of missing neonates with jaundice who need phototherapy or, in the case of overestimation, of starting phototherapy too early.

Beyond Air Appoints New Chief Medical Officer

March 23 2023

Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, announced the appointment of Dr Jeff Myers as Chief Medical Officer of the Company, effective March 27, 2023. Dr Andrew Colin, the Company’s incumbent Chief Medical Officer, has transitioned to the role of Senior Medical Director Global Clinical Leadership and will remain an integral part of the Beyond Air team. Dr Colin will be working closely with Dr. Myers to ensure a seamless transition. Dr Myers joins Beyond Air with nearly 15 years of leadership experience as a biopharmaceutical executive overseeing clinical development, clinical operations, and regulatory affairs. Prior to industry, Dr Myers was a cardiothoracic surgeon for nine years, most recently at Massachusetts General Hospital. “We are excited to appoint Dr Myers as our Chief Medical Officer. Being an accomplished cardiothoracic surgeon with success at several healthcare companies in medical capacities provides Dr Myers with the attributes Beyond Air needs as we move forward with developing the pipeline for our revolutionary LungFit platform,” stated Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “I want to thank Dr Colin for his commitment to Beyond Air and look forward to working with him in his new role.” “I am excited to join Beyond Air’s highly accomplished team of scientists, engineers, and investigators. This team has successfully advanced development of the Company’s pipeline, including announcing the first FDA-approved product for the LungFit platform in mid-2022. I look forward to building upon this momentum as we continue to harness the power of nitric oxide to treat a broad variety of indications,” commented Dr Myers. Dr Myers’ previous leadership responsibilities include overseeing clinical development, clinical operations, business development, medical affairs, and implementing regulatory strategies in the US and abroad. Previously, he was the Chief Medical Officer for Revolo Biotherapeutics, initiating clinical trials in the US and Europe before leaving to become the CEO of Bioceptive where he continues to serve as a member of the Board of Directors. Dr Myers also served as the Chief Medical Officer for Portola Pharmaceuticals where he was instrumental in the acquisition by Alexion Pharmaceuticals, and Vice President, Medical and Regulatory Affairs, at SteadyMed Therapeutics. Prior to beginning his career in biotechnology, he was a practicing congenital cardiac surgeon and served as the Chief of Pediatric Cardiac Surgery at Tulane University and Massachusetts General Hospital with appointments to Tulane and Harvard Medical Schools. He is passionate about developing novel, first-in-class therapies that significantly improve the lives of patients. Dr Myers began his work with inhaled nitric oxide in pursuit of his PhD at Georgetown University and is thrilled to join Beyond Air and its pursuit of the potential of these therapies across multiple indications in critically ill patients. In connection with the appointment of Dr Myers, the Company granted Dr Myers an inducement stock option award and restricted stock unit award as inducements material to Dr Myers’ entering into employment with the Company in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The Inducement Option is being granted effective as of March 27, 2023 and is exercisable for the purchase of 50,000 shares of the Company’s common stock, at an exercise price equal to the last reported sale price on Nasdaq on March 27, 2023. The Inducement RSU for 50,000 shares of the Company’s common stock is being granted effective as of March 27, 2023. The Inducement Awards were approved by the independent compensation committee of the Board in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The Inducement Option has a ten-year term and will vest over a four-year period, with 25% of the shares underlying the stock option award vesting on the first anniversary of the date of grant and annually thereafter in three equal installments, subject to Dr Myers’ continued service with the Company through the applicable vesting dates. The Inducement RSU will vest over a five-year period, with 20% vesting in December 2023 and 20% annually thereafter. The Inducement Awards are subject to the terms and conditions of the Company’s 2013 Equity Incentive Plan.

Etiometry Announces CE Mark and Health Canada Authorization for Adult Use of AI-Based Algorithm that Detects Risk of Hypercapnia

March 21 2023

Etiometry, the leader in clinical decision-support software for critical care, today announced CE Mark and Health Canada authorization of its IVCO2 Index for adult populations, which allows clinicians to visualize inadequate ventilation of carbon dioxide with other contextual data from the Etiometry Platform to help inform intervention decisions and get ahead of patient deterioration. The IVCO2 Index was first FDA-cleared for pediatric use in 2019 and now carries CE Mark and Health Canada licenses for both pediatric and adult use. On the heels of January’s FDA clearance of its IDO2 Index for adults – which was previously licensed for adult use by Health Canada and CE Marked in 2022 – Etiometry continues to seek authorizations for all of its risk algorithms to be used for both pediatrics and adults in the U.S., Canada and Europe. “We are serious in our pursuit to expand authorizations of all four of our current risk indices,” said Shane Cooke, CEO of Etiometry. “What drives us forward is knowing how our precision analytics bring situational awareness to strained care teams to help mitigate risk and enhance patient outcomes.”  Using mathematical models of human physiology to determine the likelihood a patient is experiencing inadequate carbon dioxide (CO2) ventilation or hypercapnia, Etiometry’s IVCO2 Index continuously tracks the probability that a patient’s arterial blood gas sample has a partial pressure of CO2 (PaCO2) less than 50 mmHg - with the ability to select patient-specific thresholds at the bedside. The IVCO2 Index provides care teams an additional safety net to detect deterioration in patients with conditions that require tight control of PaCO2 or when V/Q mismatch can hamper the management of PaCO2. The IVCO2 Index, along with Etiometry’s other risk indices, indicate the probability a patient will experience a harmful physiologic state and can also be embedded into the Etiometry Platform’s growing list of automated clinical pathways to improve length of stay and decrease ventilation time.

Neonatal Bilirubin Meters Need Better Accuracy

March 16 2023

Despite their convenience and low cost, handheld point-of-care (POC) devices lack precision for measuring neonatal bilirubin and need refinement in order to tailor jaundice management in newborns, a systematic review and meta-analysis reports in JAMA Pediatrics. Lauren E.H. Westenberg, MD, of the division of neonatology at Erasmus MC Sophia Children’s Hospital in Rotterdam, the Netherlands, and colleagues reported that POC meters tended to underestimate neonatal bilirubin levels, compared with conventional laboratory-based quantification. Furthermore, pooled estimates from 10 studies found these devices to be too imprecise overall, with substantial outer-confidence bounds. On the plus side, Dr Westenberg’s group said POC bilirubin testing was as much as 60 times faster than lab measurement, and used 40-60 times less blood. “Conventional laboratory-based bilirubin quantification usually requires up to 500 mcL, but sometimes even 1,500 mcL, while POC tests require up to 50 mcL, which means less stress for the baby,” Dr Westenberg said in an interview. “Especially when infants are cared for at home, it usually takes a few hours between deciding to quantify bilirubin and obtaining the test result. Meanwhile, bilirubin levels may rise unnoticed.” On the positive side, POC devices are useful where laboratories in low-resource areas may be remote, poorly equipped, and not always able to provide an accurate bilirubin level. “As a result, the diagnosis of jaundice relies mainly on visual inspection, which is known to be unreliable,” she said. POC devices, however, need near-perfect conditions for optimal use, and results can be affected by humidity, preanalytic conditions such as test strip saturation, and hematocrit. Yet results from these devices have recently proven to have acceptable accuracy, resulting, for example, in the same clinical decisions as the reference standard in 90.7% of times according to a 2022 study in a hospital in Malawi. Nevertheless, the authors concluded that the devices’ imprecision limits their widespread use in neonatal jaundice management, especially when accurate lab-based bilirubin quantification is available. Results from these POC tests should be interpreted with caution, Dr Westenberg said. In terms of clinical decision-making, POC devices entail a risk of missing neonates with jaundice who need phototherapy or, in the case of overestimation, of starting phototherapy too early.

Human and Nonhuman Milk Products Have Similar Effect on Preemies' Gut Microbiota

March 16 2023

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the UK study, published online in JAMA Network Open. The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.” Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers. The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference. Neither, however, was powered to detect a clinically important difference in surgical NEC.

Infinant Health, Inc Announces “Clean Label Project” and “First 1,000 Day Promise” Certifications for Evivo

March 15 2023

Infinant Health, Inc, a company focused on improving infant health through the gut microbiome, announced that it received the "Clean Label Project" and "First 1,000 Day Promise" certifications from the Clean Label Project on its flagship product, Evivo, an infant probiotic. Infinant's Evivo is used by parents at home as well as in healthcare environments, including with the most vulnerable infant populations in the NICU. The Clean Label Project is a national non-profit committed to transparent food and consumer product labeling. Their awards are given to products that emphasize purity and surpass FDA regulations. Product awards are designated based on safety and require rigorous product sampling and testing. The Clean Label Project's First 1,000 Day Promise standard uses elements of European food regulations to set thresholds products for pregnant women, infants, lactating mothers, and children. Infinant Health's mission is to change the trajectory of human health, one baby at a time, through a deep understanding of infant nutrition and the gut microbiome. The company offers Evivo, an infant probiotic containing B. infantis EVC001, a proprietary strain that helps infants develop a healthy microbiome.  B. infantis EVC001 has unique features that work with human milk to reduce potential harmful bacteria and support healthy immune system function. Potentially harmful bacteria are linked to inflammation and this inflammation may be associated with prevalent childhood issues such as allergies and type 1 diabetes. Evivo is a food for special dietary use, meeting all FDA regulations for food products, and has been used by hospitals, providers and parents for five years with over 4 million feedings to date in over 60,000 babies. "Infinant Health is committed to creating high-quality nutritional products," said Anthony Franco, Chief Operating Officer for Infinant Health. "We maintain best-in-class standards for product testing, manufacturing, packaging and distribution. These certifications are a testament to our commitment to quality and leadership in infant health. At Infinant Health, we focus on a continuous improvement process to perfect our product – that starts by creating and following the highest standards in quality. The Clean Label certifications reflect this commitment." Infinant Health uses third-party testing to ensure viability and purity. Each manufacturing batch of Evivo includes a Certificate of Conformance, and all packaging is BPA free and protects Evivo from moisture, light and oxygen. "Much of the narrative we've been hearing lately about baby food safety is limited to cereals, fruits, and veggies. In addition to the food marketed towards children and toddlers, the focus should include pregnant women, newborns, infants, and lactating mothers," said Jaclyn Bowen, executive director at Clean Label Project. "As a mother and public health practitioner, it's exciting to see brands like Infinant Health, voluntarily choosing to think of food safety differently and setting even stricter specifications than regulations require when it comes to ingredient quality and safety." These efforts are in line with the FDA Closer to Zero initiative aimed to make food safer for babies and young children. Infinant Health supports the FDA's commitment to setting regulations to minimize chemical contaminants.

Babies' Movement in the Womb Means Something

March 1 2023

The random movements that babies make while in the womb help boost their sensorimotor movement that will aid them after birth, according to researchers at the University of Tokyo.
What to know: The hundreds of neurons that control each muscle are synchronized in a fetus to create strong contractions that stimulate its activity. Random movements of babies in the womb help their development and boost the growth of their sensorimotor system, which supports everything from language development, cognitive growth, and hand– eye coordination to problem solving skills and social interaction. Infants develop their own sensorimotor system based on explorational behavior or curiosity, so they are not just repeating the same action but a variety of actions implying a linkage between early spontaneous movements and spontaneous neuronal activity.

Newborns and infants can acquire coordination skills through spontaneous whole-body movements without an explicit purpose or task, showing more common patterns and sequential movements, with an increase in coordinated whole-body and anticipatory movements as they grow older.

Understanding how the sensorimotor system develops starting in vitro could lead to understanding and treating a wide range of neurodegenerative disorders such as multiple sclerosis, spinal cord injuries, motor neuron disease, and even cerebral palsy.

Maternal COVID-19 Vaccine Curbs Infant Infection From Delta Variant

March 1 2023

Maternal vaccination with two doses of the mRNA COVID-19 vaccine was 95% effective against infant infection from the delta variant, and 45% effective against infant infection from the omicron variant, a new study shows. Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, MD, of the University of Toronto, and colleagues in their article published in The BMJ. In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022. Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date. Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date. The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants. The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls). Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron. The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.

Moms’ and babies’ medical data predicts prematurity complications, Stanford Medicine-led study shows

February 27 2023

By sifting through electronic health records of moms and babies using a machine-learning algorithm, scientists can predict how at-risk newborns will fare in their first two months of life. The new method allows physicians to classify, at or before birth, which infants are likely to develop complications of prematurity. A study describing the method, developed at the Stanford School of Medicine, was published online in Science Translational Medicine. “This is a new way of thinking about preterm birth, placing the focus on individual health factors of the newborns rather than looking only at how early they are born,” said senior study author Nima Aghaeepour, PhD, an associate professor of anesthesiology, perioperative and pain medicine and of pediatrics. The study’s lead authors are postdoctoral scholar Davide De Francesco, PhD, and Jonathan Reiss, MD, an instructor in pediatrics. Traditionally defined as birth occurring at least three weeks early, premature birth is linked to complications in babies’ lungs, brains, vision, hearing and digestive system. Although earlier births generally carry higher risks, the timing of birth predicts only approximately how a specific infant will fare. Some infants who are born quite early develop no complications, while others born at the same stage of pregnancy become very ill or die. “Preterm birth is the single largest cause of death in children under age 5 worldwide, and we haven’t had good solutions,” Aghaeepour said. “By focusing our research on predicting the health of these babies, we can optimize their care.” Many complications of prematurity take days or weeks after birth to emerge, causing substantial damage to newborns’ health in the meantime. Knowing which infants are at risk could enable preventive measures. “We look mainly at the baby to make treatment decisions in neonatology, but we are finding that we can get valuable information from the maternal health record, really homing in on how individual babies’ trajectories have been shaped by exposure to their specific maternal environment,” said study coauthor David Stevenson, MD, a neonatologist at Lucile Packard Children’s Hospital Stanford, professor of pediatrics and director of the March of Dimes Prematurity Research Center at the Stanford School of Medicine. “This is a move toward precision medicine for babies,” he added.

NICU Use Up, Birth Weights Down in Babies of Mothers with HCV

FEBRUARY 15 2023

Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity. Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine. As Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.” For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001). The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity. An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Hughes said. There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34). No difference in outcomes was seen when HCV cases with viremia (33%) were excluded. “The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Hughes said.

Maternal COVID-19 Vaccine Curbs Infant Infection from Delta Variant

FEBRUARY 15 2023

Maternal vaccination with two doses of the mRNA COVID-19 vaccine was 95% effective against infant infection from the delta variant, and 45% effective against infant infection from the omicron variant, a new study shows. Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, MD, of the University of Toronto, and colleagues in their article published in The BMJ. In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022. Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date. Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date. The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants. The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls). Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron. The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively. The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant. The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively). Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.

Hope for Catching Infants With CP Early

FEBRUARY 1 2023

A new prognostic tool may help identify infants with cerebral palsy (CP) earlier, allowing them to receive therapies to improve later outcomes. Researchers from Canada used 12 clinical variables to predict the condition. The tool accurately predicted 75% of CP cases. The study was published January 17 in JAMA Pediatrics. The prevalence of CP in the US is two to three children per 1000, a rate that has been relatively unchanged for decades. Although recent innovations in diagnosis using motor scores and MRI scans have aided in diagnosis, these techniques have historically been reserved only for infants who were cared for in neonatal intensive care units, were born prematurely, or who had other neurologic risk factors, such as birth defects. The tool identified 2.4 times more children with CP than would have been detected using current diagnostic methods, according to the researchers. "We developed the prediction tool to try to make these findings accessible to any healthcare provider, which will hopefully help break down the long-held perception that CP is usually related to prematurity or a difficult delivery," said Mary Dunbar, MD, an author of the study. "We know that about half of children with CP aren't premature and didn't have a particularly difficult birth."

The bedside tool weighs factors such as the use by mothers of illicit drugs and tobacco; the presence of diabetes and preeclampsia during pregnancy; whether the infant is male; birth weight; and the number of miscarriages the mother had prior to the birth. The tool also factors in results from a test that measures how well the infant is adjusting to life outside the womb. Dunbar and her colleagues compared 1265 infants with CP from the Canadian Cerebral Palsy Registry from 2003 to 2019 to a control group of 1985 children without CP from the Alberta Pregnancy Outcomes and Nutrition longitudinal study. The study authors hope that the prognostic tool can be integrated into existing newborn screenings and completed by nurses or physicians as part of routine care. "Its cost is low especially in comparison to MRI and specialized neurological assessments," said Sarah Taylor, MD, section chief of neonatal-perinatal medicine at Yale New Haven Children's Hospital in Connecticut. Health systems and doctors may be more apt to adopt the tool, since it does not require specialized equipment or training, Taylor added.

State Quality Initiative Can Reduce Postpartum Hemorrhage and Maternal Morbidity

January 16 2023

A statewide quality initiative can improve severe maternal morbidity (SMM) and reduce the incidence of maternal morbidity and mortality from postpartum hemorrhage (PPH), a modeling analysis found. Such measures could potentially provide savings to birthing hospitals, according to the California cost-effectiveness study, published in Obstetrics & Gynecology. A team led by Eric C. Wiesehan, MHA, MBA, a PhD candidate in health policy at Stanford (Calif.) University, examined the effects of the safety initiative of the California Maternal Quality Care Collaborative (CMQCC) in a theoretical cohort of 480,000 births across a mix of hospital settings and sizes. The CMQCC developed a PPH toolkit and quality-improvement protocol to increase recognition, measurement, and timely response to PPH. Drawing retrospectively on a large 2017 California implementation study, the simulation estimated that collaborative implementation of the CMQCC added 182 quality-adjusted life-years (0.000379 per birth) by averting 913 cases of SMM, 28 emergency hysterectomies, and one maternal mortality. Additionally, it saved $9 million ($17.78 per birth) owing to avoided SMM costs. According to the Centers for Disease Control and Prevention, pregnancy-related maternal deaths in the United States have increased from 7.2 per 100,000 live births to 16.9 per 100,000 live births over the past 20 years, making it the only country in the Organization for Economic Cooperation and Development with rising rates of maternal mortality. PPH accounts for 11% of maternal deaths. As to the study’s broader applicability, Dr. Wiesehan said in an interview, “findings of effectiveness in terms of reducing PPH-related SMM are well known outside of California. In terms of costs, however, it is more of an unknown how much is generalizable. It would go a long way if another state quality care collaborative implementing such a project recorded costs prospectively. Prospective costing, particularly microcosting, would be optimal to precisely place where the most, or least, value of this quality improvement project is achieved.”

Infantile Hemangioma: Analysis Underscores Importance of Early Propranolol Treatment

January 16 2023

Among patients with infantile hemangioma (IH), initiation of oral propranolol 3 mg/kg/day prior to 10 weeks of age was associated with a significantly better rate of treatment success, results from a post-hoc analysis of phase 2 and 3 clinical trial data showed. “It is widely accepted that oral propranolol should be started early to improve the success rate, but proposed thresholds have lacked supportive data,” researchers led by Christine Léauté-Labrèze, MD, of the department of dermatology at Pellegrin Children’s Hospital, Bordeaux, France, wrote in the study, which was published online in Pediatric Dermatology. In the pivotal phase 2/3 trial of propranolol of 460 infants, published in 2015, the mean initiation of treatment was 104 days, they added, but “in real-life studies, most infants are referred later than this.” In addition, a European expert consensus panel set the ideal age for a patient to be seen by a specialist at between 3 and 5 weeks of age, while an American Academy of Pediatrics Clinical Practice Guideline set the ideal age at 1 month. To determine factors associated with a higher success rate with oral propranolol treatment, such as age at treatment initiation, the researchers analyzed data from the pivotal phase 2-3 clinical trial of oral propranolol in IH. They used Generalized Additive Model (GAM) charts with Generalized Linear Models (GLM), then a rule discovery algorithm, to identify subgroups presenting a high probability of occurrence of the predefined outcome: success at 6 months of treatment (defined as complete or nearly complete resolution of the target hemangioma). Study coauthors were Ilona J. Frieden, MD, of the department of dermatology at the University of California, San Francisco, and director of the UCSF Birthmarks & Vascular Anomalies Center; and Alain Delarue, MD, of medical affairs at Pierre Fabre Dermatologie, Lavaur, France, which markets the pediatric formulation of propranolol approved by the Food and Drug Administration in 2014 for treating IH. They found that patients who started oral propranolol 3 mg/kg/day before the age of 10 weeks had a success rate of 86%, while those who started treatment after 10 weeks of age had a success rate of 60%. “Our clinical experience suggested that starting early propranolol gave better results on infantile hemangiomas; however, we were surprised” by the significance of the difference, the three study authors stated in an e-mail reply to this news organization.

EU Commission Approves Delay in Medical Devices Law to Avert Shortages

January 16 2023

The European Commission said it approved delaying the deadline for companies to comply with a new law regulating medical devices in order to prevent shortages of lifesaving equipment. The proposal now must be adopted by the European Parliament and Council through an accelerated process, the EU executive said in a statement. EU Health Commissioner Stella Kyriakides submitted the proposal, saying challenges in implementing the law were threatening supplies of critical devices, such as catheters used for surgeries on newborns with heart conditions. The law requires all devices to be re-certified by May 2024, but the new proposed deadlines push that back to the end of 2027 and the end of 2028, depending on the risk classification of the device. The Medical Devices Regulation came into effect in 2021 and was introduced after the 2010 scandal of exploding breast implants manufactured by a French company that exploited loopholes to sell faulty products at profit.

VERO Biotech Receives FDA Approval of its Third Generation Tankless Inhaled Nitric Oxide Delivery System

January 9 2023

VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system.

GENOSYL DS is a tankless and portable system engineered with redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients with an easy-to-use interface and portability features. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden.

The Third Generation GENOSYL® Delivery System – developed for respiratory therapists by respiratory therapists – has new features that are expected to deliver three key benefits for patients, clinicians and providers.

These include:

Faster dosing, enabled by an adaptive sensor and automated cassette activation that accelerate time to achieve the desired dose.

Simpler workflow, as clinicians can now work from one console. The new delivery system has a dual cassette bay within each console, and transitions cassettes automatically. Previously, with a single cassette, clinicians needed to transition to a second console.

Operational efficiency, facilitated by an improved user interface and smaller, lighter disposable cassettes that alleviate storage constraints within hospitals.

"The enhancements to the GENOSYL Delivery System Console will help me to work more efficiently," said Denise Lauderbaugh, MPH, BSRC, RRT-NPS and Clinical Practice Specialist, Rady Children's Hospital, San Diego, CA. "It has two cassettes in one console, and they are even smaller than before; it automatically activates and transitions to the second cassette when the first one is depleted; and I no longer have to transition from a primary to a standby console. I can care for my patients through the operation of just one console," she added.

"The continuous innovation of the GENOSYL Delivery System represents our commitment to neonatal intensive care and the acute care hospital community in providing solutions to the challenges they face," said Brent V. Furse, CEO and President, VERO Biotech. "We are grateful for the partnership and support we received with the launch of our innovative tankless GENOSYL Delivery System and this collaboration that has and will allow VERO Biotech to continue to expand on its mission to save lives, alleviate suffering and improve the health economics of acute care."

GENOSYL DS is the first tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration (FDA). Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension. Unlike tank-based systems, GENOSYL DS generates iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks and helps to simplify clinical workflow.

GENOSYL (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Important Safety Information

• GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
• Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
• Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours.
• Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.
• In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.
• The most common adverse reaction is hypotension.
• Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
• GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.

Visit www.vero-biotech.com for the full Prescribing Information for GENOSYL.

New Prospective Study Evaluates the Accuracy of Monitoring During Elective Cesarean Section

JANUARY 3 2023

Masimo announced the findings of a prospective study published in the Egyptian Journal of Anesthesia in which Dr. Mohamed Ibrahim Beleta and colleagues at Cairo University evaluated the accuracy of noninvasive, continuous hemoglobin monitoring with Masimo SpHb on patients undergoing elective cesearan section (CS) with antepartum hemorrhage. The researchers found significant positive correlations between SpHb and invasive hemoglobin (Hb) values, and concluded, “In patients undergoing CS with antepartum hemorrhage, continuous SpHb through Masimo Pulse CO-Oximetry demonstrated clinically acceptable accuracy of Hb measurement compared with invasive Hb, even at low hemoglobin levels.” The authors note that antepartum hemorrhage is associated with adverse maternal and neonatal outcomes and that blood transfusion is also associated with a variety of risks, but that invasive laboratory hemoglobin measurement, while a crucial factor in transfusion decisions, yields intermittent and often delayed results. The researchers thus sought to evaluate whether use of noninvasive, continuous hemoglobin monitoring might “enable a more rapid detection of clinically significant blood loss, improve perioperative transfusion practices, allow patient condition to be assessed more quickly and blood management more adequately, and perhaps even reduce needless transfusions.” They enrolled 60 pregnant women, aged 18-45, scheduled for elective CS under general anesthesia between April 2016 and December 2017. All subjects had antepartum hemorrhage and were candidates for blood transfusion. During the procedure, all patients were monitored as per hospital standards, and in addition, with Masimo SpHb. All blood samples (Lab Hb) were analyzed using the same Coulter laboratory analyzer to avoid variance induced by the use of multiple devices. Lab Hb and SpHb values were recorded before induction of anesthesia (baseline), before transfusion, and after transfusion. Blood transfusion was carried out when Lab Hb decreased by more than 20% from baseline. The researchers found significant positive correlations between SpHb and invasive Hb at the three points of comparison: baseline (r = 0.946), pre-transfusion (r = 0.902), and post-transfusion (r = 0.698). Differences at those times were insignificant: p = 0.196, p = 0.092, and p = 0.570, respectively. Using Bland-Altman analysis, they found low bias and moderate limits of agreement: 0.348 g/dL (-0.584 and 1.280) at baseline measurement, 0.314 g/dL (-0.561 and 1.188) at pre-transfusion, and 0.348 g/dL (-0.584 and 1.280) at post-transfusion. The investigators concluded, “Continuous SpHb Masimo Pulse CO-Oximetry shows an appropriate clinically reliable Hb calculation in comparison to Invasive Hb even in patients undergoing CS with low hemoglobin. Further studies are needed on larger sample size with multicenter collaboration. Furthermore, we recommend the assessment of this technique on patients with common morbidities, such as high cholesterol, high blood pressure, and diabetes.” The researchers also noted that “SpHb evaluation has the potential for additional benefits, including patient comfort, increased safety, and decreased complexity for healthcare staff, who are not exposed to the risks of needle-stick injury and bloodspill contamination.” SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

Vaccinating Pregnant Women Protects Infants Against Severe RSV Infection

DECEMBER 30 2022

An investigational vaccine against respiratory syncytial virus (RSV) in pregnant women has been shown to help protect infants against severe disease, according to the vaccine's manufacturer. Pfizer recently announced that in the course of a randomized, double-blind, placebo-controlled phase 3 study, the vaccine RSVpreF had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life, according to a company press prelease. The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. A total of 7400 women had received a single dose of 120 μg RSVpreF in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants. Due to the good results, the enrollment in the study was halted on the recommendation of the study's Data Monitoring Committee after achieving a primary endpoint. The company plans to apply for marketing authorization to the US Food and Drug Administration (FDA) by the end of 2022, and to other regulatory agencies next year. "The directness of the strategy, to vaccinate expectant mothers during pregnancy so that their newborn is then later protected, is new and a very interesting approach," commented Prof. Ortwin Adams, MD, head of virologic diagnostics at the Institute for Virology of the University Hospital of Düsseldorf to the Science Media Center (SMC).

Mothers' Sleep Issues Promote Poor Outcomes for Infants

DECEMBER 30 2022

Outcomes were significantly more likely for infants whose mothers had diagnoses of sleep apnea or insomnia, based on data from approximately 5000 infants. Sleep disturbance is common during pregnancy, and "sleep disorders during pregnancy can have significant consequences for both the pregnant person and their infant," write Jennifer N. Felder, PhD, of the University of California San Francisco, and colleagues. However, data on the impact of maternal insomnia on specific infant outcomes are limited, they said.

In a study published recently in the journal Sleep Health, the researchers reviewed data from 3371 pregnant women diagnosed with sleep apnea and 3213 with insomnia. Of these, 2357 and 2212 were matched with controls in a propensity-score analysis. The referent controls were matched for maternal characteristics, obstetric factors, and infant factors among individuals without a sleep disorder. All were singleton pregnancies.

Three Antiseizure Medications Join List for Newborn Risks

DECEMBER 30 2022

A study of more than 4 million births over 20 years in five Scandinavian countries has reported that three antiseizure medications should be used with caution in women of child-bearing age because they were associated with low birth weights. In results presented at the annual meeting of the American Epilepsy Society, Jakob Christensen, MD, DSc, PhD, a professor at Aarhus University Hospital in Denmark, said that the study found that carbamazepine, oxcarbazepine, and topiramate were associated with low birth weight and increased risk of infants being born small for gestational age. “Because we have this large data set we were able to confirm the suspicion that’s been raised in the past that these drugs may be associated with low birth weight,” Dr Christensen said in an interview. The study analyzed records from population-based registers of 4.5 million births in Denmark, Finland, Iceland, Norway, and Sweden between 1996 and 2017, known as the SCAN-AED project. The researchers analyzed the association between prenatal use of antiseizure medications and birth weight, defining low birth weight as less than 5.5 pounds and small for gestational age as being in the lowest 10th percentile for sex, country, and gestational weight at birth.

‘New Era’ for Company With Breastfeeding Device

DECEMBER 29 2022

Neotech Products announced the acquisition of the Bridge Breastfeeding Assistance Device. The Bridge features a silicone nipple cover with a built-in channel, which attaches to a syringe that can hold and deliver breastmilk or formula. It helps babies latch to the breast and helps promote milk production. It can be used in most circumstances in which a bottle would traditionally be used. The Bridge was invented by Kate Spivak, a Physician Assistant and an International Board Certified Lactation Consultant. “I created the Bridge because there was a lack of solutions for the most common issues I was seeing in practice,” Spivak said. “I consistently saw babies who were being supplemented with a bottle due to low supply and issues with latch. Theoretically, the solution was simple: keep the baby at the breast as much as possible. Realistically, there was no efficient way to do that until the Bridge was created.” The Bridge Breastfeeding Assistance Device: Provides a surface for baby to latch and allows supplementation while breastfeeding which helps to stimulate natural milk production; can be used to provide colostrum, expressed milk, fortified human milk, or formula; allows precise control of supplement flow, rate, and timing. A large percentage of mothers experience breastfeeding challenges, including difficulty with infant feeding at the breast, pain, and milk quantity. “Neotech is primarily known as a NICU company, but the Bridge is a natural progression into the Mother Baby market,” Craig McCrary, Neotech President said. “We have a few other products in the works for the Mother Baby space. The Bridge marks the start of a new era for Neotech.”

Mothers' Sleep Issues Promote Poor Outcomes for Infants

DECEMBER 15 2022

Several adverse infant outcomes were significantly more likely for infants whose mothers had diagnoses of sleep apnea or insomnia, based on data from approximately 5000 infants. Sleep disturbance is common during pregnancy, and "sleep disorders during pregnancy can have significant consequences for both the pregnant person and their infant," write Jennifer N. Felder, PhD, of the University of California San Francisco, and colleagues. However, data on the impact of maternal insomnia on specific infant outcomes are limited, they said. In a study published in the journal Sleep Health, the researchers reviewed data from 3371 pregnant women diagnosed with sleep apnea and 3213 with insomnia. Of these, 2357 and 2212 were matched with controls in a propensity-score analysis. The referent controls were matched for maternal characteristics, obstetric factors, and infant factors among individuals without a sleep disorder. All were singleton pregnancies. Compared with matched controls, the infants born to mothers with sleep apnea had a significantly increased risk for any adverse outcome (50.1% vs 53.5%) and of the specific outcomes of low 1-minute Apgar scores (6.3% vs 9.6%), NICU stays (6.3% vs 8.4%), and an emergency department visit in the first year of life (33.6% vs 36.9%). For infants born to mothers with insomnia, the only significant difference in outcomes compared with controls was an increased likelihood of an emergency department visit (37.2% vs 32.3%).

Three Antiseizure Medications Join List for Newborn Risks

DECEMBER 15 2022

A study of more than 4 million births over 20 years in five Scandinavian countries has reported that three antiseizure medications should be used with caution in women of child-bearing age because they were associated with low birth weights. In results presented at the annual meeting of the American Epilepsy Society, Jakob Christensen, MD, DSc, PhD, a professor at Aarhus University Hospital in Denmark, said that the study found that carbamazepine, oxcarbazepine, and topiramate were associated with low birth weight and increased risk of infants being born small for gestational age. “Because we have this large data set we were able to confirm the suspicion that’s been raised in the past that these drugs may be associated with low birth weight,” Christensen said in an interview. The study analyzed records from population-based registers of 4.5 million births in Denmark, Finland, Iceland, Norway, and Sweden between 1996 and 2017, known as the SCAN-AED project. The researchers analyzed the association between prenatal use of antiseizure medications and birth weight, defining low birth weight as less than 5.5 pounds and small for gestational age as being in the lowest 10th percentile for sex, country, and gestational weight at birth. The antiseizure medications and adjusted odds ratios for risk of low birth rate were:

• Carbamazepine, 1.44 (95% confidence interval [CI], 1.21-1.71).
• Oxcarbazepine, 1.32 (95% CI, 1.03-1.69).
• Topiramate, 1.60 (95% CI, 1.15-2.24).
• Pregabalin, 1.23 (95% CI, 1.02-1.48).
• Clobazam, 4.36 (95% CI, 1.66-11.45).

The odds ratios for being born small for gestational age were:

• Carbamazepine, 1.25 (95% CI, 1.11-1.41).
• Oxcarbazepine, 1.48 (95% CI, 1.27-1.73).
• Topiramate, 1.52 (95% CI, 1.20-1.91).

“Prenatal exposure to carbamazepine, oxcarbazepine, and topiramate were associated with all estimates of adverse birth weight outcomes, thus confirming results from preclinical studies in animals and previous smaller studies in humans,” Christensen said.

Study Looks at Biomarkers During Pregnancy

DECEMBER 12 2022

A discovery by Stanford School of Medicine researchers of biomarkers in the blood and urine of women who later develop a dangerous complication of pregnancy could lead to a low-cost test to predict the condition. The findings, which were published online Dec. 9 in Patterns, lay the groundwork for predicting preeclampsia — one of the top three causes of maternal death worldwide — months before a pregnant woman shows symptoms. Predictive testing would enable better pregnancy monitoring and the development of more effective treatments. Preeclampsia is characterized by high blood pressure late in pregnancy. It affects 3% to 5% of pregnancies in the United States and up to 8% of pregnancies worldwide, and it can lead to eclampsia, an obstetric emergency linked to seizures, strokes, permanent organ damage and death. At present, preeclampsia can be diagnosed only in the second half of pregnancy, and the sole treatment is to deliver the baby, putting infants at risk from premature birth. “The advantage of predicting early in pregnancy who will get preeclampsia is that we could follow moms more closely for early symptoms,” said the study’s co-lead author, Ivana Marić, PhD, a senior research scientist in pediatrics at Stanford Medicine. In addition, taking low-dose aspirin starting early in pregnancy may lower preeclampsia rates in women at risk for the condition, but pinpointing who could benefit has been challenging, Marić said. “There is really a need to identify those pregnancies to prevent tragic outcomes for mothers, and preterm births for babies, which can be very dangerous.” Marić shares lead authorship of the study with Kévin Contrepois, PhD, former scientific director of the Stanford Medicine Metabolic Health Center. The study’s senior authors are Nima Aghaeepour, PhD, associate professor of pediatrics and of anesthesiology, perioperative and pain medicine; Brice Gaudilliere, MD, PhD, associate professor of anesthesiology, perioperative and pain medicine; and David Stevenson, MD, professor of pediatrics and director of the Stanford Prematurity Research Center, which supported the research. “When you reduce preeclampsia, you also likely reduce preterm birth,” Stevenson said. “It’s a double whammy of good impacts.” To figure out which biological signals could provide an early warning system for preeclampsia, the Stanford Medicine research team collected biological samples from pregnant women who did and did not develop preeclampsia. They conducted highly detailed analyses of all the samples, measuring changes in as many biological signals as possible, then zeroing in on a small set of the most useful predictive signals. “We used a number of cutting-edge technologies on Stanford University’s campus to analyze preeclampsia at an unprecedented level of biological detail,” Aghaeepour said. “We learned that a urine test fairly early on during pregnancy has a strong statistical power for predicting preeclampsia.” The research team collected biological samples at two or three points in pregnancy (early, mid and late) in 49 women, of whom 29 developed preeclampsia during their pregnancies and 20 did not. The participants were selected from a larger cohort of women who had donated biological samples for pregnancy research at Stanford Medicine. For each time point, the participants gave blood, urine and vaginal swab samples. The samples were used to measure six types of biological signals: all cell-free RNA in blood plasma, a measure of which genes are active; all proteins in plasma; all metabolic products in plasma; all metabolic products in urine; all fat-like molecules in plasma; and all microbes/bacteria in vaginal swabs. The scientists also conducted measurements of all immune cells in plasma in a subset of 19 of the participants. Using the resulting thousands of measurements, as well as information about which participants developed preeclampsia and when in pregnancy each sample was collected, the scientists used machine learning to determine which biological signals best predicted who progressed to preeclampsia. They aimed to identify a small set of signals detectable in the first 16 weeks of pregnancy that could form the basis for a simple, low-cost diagnostic test feasible to use in low-, middle- and high-income countries. To estimate the accuracy of the machine learning models, the women were divided into two cohorts, a discovery cohort and a validation cohort. The researchers initially constructed the models with data from the discovery cohort, then confirmed the results by testing their performance on data from women in the validation cohort. A prediction model using a set of nine urine metabolites was highly accurate, the researchers found. These urine markers, in samples collected before week 16 of pregnancy, strongly predicted who later developed preeclampsia. The performance of the test was measured by a statistical standard used in machine learning known as area under the curve. An AUC of 1 for a test with two possible outcomes indicates perfect prediction, whereas an AUC of 0.5 indicates no predictive value, the same as the results obtained from a coin toss. For the urine markers, the AUC was 0.88 in the discovery cohort and 0.83 in the validation cohort, indicating high prediction capability. Measuring the same set of urine metabolites in samples collected throughout pregnancy produced similar predictive power, with an AUC of 0.89 in the discovery cohort and 0.87 in the validation cohort. The researchers confirmed that their model had stronger predictive power than using only clinical features linked to a pregnant woman’s preeclampsia risk, such as chronic hypertension, high body mass index and carrying twins.

Medication Approved for Neonatal Seizures

DECEMBER 9 2022

Sun Pharmaceutical Industries Limited announced that the US Food and Drug Administration (US FDA) has approved SEZABY (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. With this approval, SEZABY becomes the first and only product specifically indicated in the US for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the US in Q4FY23. SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the US FDA for the treatment of neonatal seizures. SEZABY was recently licensed by SPARC to Sun Pharma. Under the terms of the license agreement, SPARC is eligible to receive a milestone payment on approval of SEZABY by the US FDA. “SEZABY is an exciting addition to our growing portfolio of specialty branded products in the U.S.,” said Abhay Gandhi, CEO North America, Sun Pharma. “As the first and only product specifically indicated to treat seizures in term and preterm infants, SEZABY has the potential to make a difference in the lives of patients and their families.” “For years, physicians have had limited treatment options to manage neonates with seizures. SPARC is proud to have developed benzyl alcohol-free and propylene glycol-free phenobarbital sodium powder for injection as the first treatment option now approved by the US FDA,” said Anil Raghavan, CEO, SPARC. SEZABY was approved based on the results of NEOLEV2, a phase 2 study that levetiracetam compared to phenobarbital in the first-line treatment of neonatal seizures evaluated.

Twins Born From Embryos Frozen 30 Years Ago

NOVEMBER 30 2022

Twin babies have been born to an Oregon couple from embryos frozen more than 30 years ago. It is believed to be a new record for the longest-frozen embryos ever to result in a successful live birth. They were stored at around -196C (-323F) in liquid nitrogen on 22 April 1992. Rachel Ridgeway, a mother of four from Oregon, gave birth to the twins on 31 October. The father, Philip Ridgeway, said it was "mind-boggling". Lydia Ann and Timothy Ronald Ridgeway likely set a new record, according to the National Embryo Donation Center (NEDC), a private faith-based organisation that says it has helped birth more than 1,200 infants from donated embryos. NEDC's previous record-holder, Molly Gibson, was born in 2020 from an embryo that had been frozen for nearly 27 years. "The decision... to adopt these embryos should reassure patients who wonder if anyone would be willing to adopt the embryos that they created 5, 10, 20 years ago," said Dr John David Gordon, who performed the embryo transfer. "That answer is a resounding yes!" The twin embryos had been created for an anonymous married couple using IVF. The man was in his 50s and reportedly relied on a 34-year-old egg donor. They were kept in storage at a fertility lab on the US west coast until 2007 when the couple donated them to the NEDC in Knoxville, Tennessee for another couple to use them instead.

The Truth About Stillbirths

NOVEMBER 15 2022

A study has found that nearly one in four US stillbirths may be preventable. For pregnancies that last 37 weeks or more, that research shows, the figure jumps to nearly half. Thousands more babies could potentially be delivered safely every year. But federal agencies have not prioritized critical stillbirth-focused studies that could lead to fewer deaths. Nearly two decades ago, both the CDC and the National Institutes of Health launched key stillbirth tracking and research studies, but the agencies ended those projects within about a decade. The CDC never analyzed some of the data that was collected. Unlike with SIDS, a leading cause of infant death, federal officials have failed to launch a national campaign to reduce the risk of stillbirth or adequately raise awareness about it. Placental exams and autopsies, which can sometimes explain why stillbirths happened, are underutilized, in part because parents are not counseled on their benefits. Federal agencies, state health departments, hospitals and doctors have also done a poor job of educating expectant parents about stillbirth or diligently counseling on fetal movement, despite research showing that patients who have had a stillbirth are more likely to have experienced abnormal fetal movements, including decreased activity. Neither the CDC nor the NIH have consistently promoted guidance telling those who are pregnant to be aware of their babies’ movement in the womb as a way to possibly reduce their risk of stillbirth. The American College of Obstetricians and Gynecologists, the nation’s leading obstetrics organization, has been slow to update its own guidance to doctors on managing a stillbirth. In 2009, ACOG issued a set of guidelines that included a single paragraph regarding fetal movement. Those guidelines weren’t significantly updated for another 11 years. Perhaps it’s no surprise that federal goals for reducing stillbirths keep moving in the wrong direction. In 2005, the US stillbirth rate was 6.2 per 1,000 live births. The US Department of Health and Human Services, in an effort to eliminate health disparities and establish a target that was “better than the best racial or ethnic group rate,” set a goal of reducing it to 4.1 for 2010. When that wasn’t met, federal officials changed their approach and set what they called more “science-based” and “realistic” goals, raising the 2020 target to 5.6. The US still fell short. The 2030 goal of 5.7 was so attainable that it was met before the decade started. The 2020 rate, the most current according to the CDC, is 5.74.

Kit is First to Receive Marketing Authorization by US FDA for SMA Screening in Newborns

NOVEMBER 14 2022

PerkinElmer Inc., a global leader committed to innovating for a healthier world, today announced that the US Food and Drug Administration (FDA) has authorized the marketing of the EONIS SCID-SMA assay kit for in vitro diagnostic (IVD) use by certified laboratories for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns. This is the first FDA authorized assay for SMA screening in newborns in the United States and is part of the Company’s broader EONIS Platform. SMA is a leading genetic cause of infant death and is characterized by muscle weakness and atrophy resulting from progressive degeneration and loss of the lower motor neurons in the spinal cord and the brain stem nuclei. SCID, which is a group of rare inherited disorders characterized by the absence of both humoral and cellular immunity, can also lead to life-threatening health complications if untreated. Early detection and intervention are critical for newborns affected by either condition. “For nearly three decades, PerkinElmer has delivered innovative solutions to laboratories and clinicians worldwide that help diagnose newborns with rare diseases and inherited disorders,” said Petra Furu, general manager of reproductive health at PerkinElmer. “This authorization is a major milestone for newborn screening in the United States. Labs across the country will be able to access technologies that detect SMA and SCID, and provide them the confidence that every test meets regulatory, manufacturing and accreditation requirements.” The EONIS Platform is a robust, flexible system that utilizes real-time PCR technology to screen for both SMA and SCID using a single dried blood spot sample, combining DNA extraction and multiplexing. When combined with PerkinElmer’s JANUS liquid handler, PerkinElmer’s workflow allows for maximum automation and efficiency, and can be configured to a laboratory’s individual requirements and throughput. Other components of the platform include the EONIS DNA Extraction kit and EONIS Analysis Software. The EONIS Platform is already CE-IVD marked for use by certified laboratories in countries that accept the CE mark.

Study Finds Improved Neurodevelopmental Outcomes for Extremely Premature Infants

NOVEMBER 11 2022

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today the publication of a journal article that showed improved long-term neurodevelopmental outcomes in extremely premature infants who received Prolacta's 100% human milk-based fortifiers as part of an Exclusive Human Milk Diet (Prolacta's EHMD), compared with infants fed a cow milk-based diet in the neonatal intensive care unit (NICU). Published in the Journal of Perinatology, the retrospective, multicenter cohort study, "Neurodevelopmental Outcomes of Extremely Preterm Infants Fed an Exclusive Human Milk-Based Diet Versus a Mixed Human Milk + Bovine Milk-Based Diet: a Multi-Center Study," examined data from 252 premature infants with a birth weight of less than or equal to 1,250 grams. Researchers assessed the infants' development using the Bayley Scales of Infant Development III (BSID-III), the standard measure of infants' neurological development. They found that infants fed Prolacta's EHMD in the neonatal intensive care unit (NICU) had significantly higher BSID-III cognitive scores and a trend toward improved language scores at a corrected age of 18 to 22 months. "This long-term outcome study demonstrated promising post-discharge cognitive scores for preterm infants fed an EHMD," said lead author Amy B. Hair, MD, of the Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas. "This data is further evidence that human milk nutrition and fortification are both imperative for long-term brain development in infants born prematurely." After adjusting for birth weight, gender, and the presence of necrotizing enterocolitis (NEC) — a serious and often life-threatening intestinal disease that affects neurological development — preterm infants who received Prolacta's EHMD, compared with those fed a cow milk-based diet (CMD), had: significantly higher BSID-III cognitive scores (96.5 ± 15.1 vs. 89.6 ± 14.1; P = 0.001); improved language scores, with a difference that approached significance (85.5 ± 15.0 vs. 82.2 ± 14.1; adjusted P = 0.09). "Infants without NEC also had higher BSID-III scores if they received an EHMD vs. a cow milk-based diet," noted Hair. "This suggests additional mechanisms involved aside from NEC prevention." Nutritional management of extremely low birth weight (ELBW) infants in their first days and weeks of life has potentially long-term implications. During this crucial time, rapid growth and development of vital organs, including the brain and lungs, occurs. Furthermore, early fortification — within the very first days of life — with 100% human milk-based fortifiers is safe and proven to help achieve healthy neonatal growth in the NICU. "Studies such as this one continue to show that human milk and human milk-based fortifiers are critical for these fragile infants," explained Melinda Elliott, MD, FAAP, chief medical officer at Prolacta, and a practicing neonatologist. "The findings of this neurodevelopment study are especially significant as they demonstrate that human milk-based nutrition helps to give preterm infants the best chance at a bright future."

New Vaccine Protects Babies

NOVEMBER 2 2022

An experimental vaccine from Pfizer Inc. significantly reduced the risk of infants developing severe cases of a respiratory virus that kills hundreds of children each year, according to the company. Among mothers who received the vaccine for the respiratory syncytial virus, their infants had an 81.8% lower risk of developing severe lower respiratory tract infections requiring medical attention within three months of birth than infants whose mothers received a placebo, Pfizer said. Within the first six months of life, the risk was reduced by 69.4%, according to the company, which reported the results in a press release and said it intends to submit them for publication in a peer-reviewed scientific journal. The shot didn’t reduce the risk of nonsevere cases by a statistically significant amount in the study, however, though the company said the study’s results were sufficient to ask health regulators by the end of this year to approve the vaccine. “This is a major breakthrough after decades of lack of success,” said William Gruber, Pfizer senior vice president of vaccine clinical research and development. If approved, Pfizer’s RSV shot could be the first to go on sale for a common virus that usually causes a mild cold in healthy people but can be dangerous and even fatal in the very old and young, especially babies under one year. There is no currently approved RSV vaccine. The virus results in 58,000 hospitalizations annually of children under five years, and 100 to 500 deaths each year. Doctors have reported unusually high numbers of RSV infections in children this year, filling up hospital beds ahead of the normally busier winter season.

Immediate Skin-to-Skin Contact With Infant Improves Outcomes for Mother and Infant

OCTOBER 28 2022

Continuous skin-to-skin contact starting immediately after delivery even before the baby has been stabilised can reduce mortality by 25 per cent in infants with a very low birth weight. This according to a study in low- and middle-income countries coordinated by the WHO on the initiative of researchers at Karolinska Institutet published in The New England Journal of Medicine. Continuous skin-to-skin contact between infant and mother, or “Kangaroo Mother Care” (KMC), is one of the most effective ways to prevent infant mortality globally. The current recommendation from the World Health Organization (WHO) is that skin-to-skin contact should commence as soon as a low weight baby is sufficiently stable, which for those weighing under 2 kg at birth normally takes several days.

Connected: Preterm Infant Program Makes Progress

OCTOBER 28 2022

Martha Welch, MD, spent the better part of three decades in private practice treating children with emotional, behavioral, and developmental disorders before accepting a job on the faculty of Columbia University in New York City in 1997. She took the position, she said, with a mission: to find evidence to support what she'd observed in her practice — that parents could, by making stronger emotional connections, change the trajectory of development for preemie infants. With that understanding, Welch created Family Nurture Intervention (FNI), which has been shown to improve the development of premature babies. "We saw that no matter what happened to the baby, no matter how avoidant the baby might be, we're able to overcome this with emotional expression," said Welch, who is now a professor of psychiatry at Columbia University Medical Center. Over the course of the intervention, families work with a specialist who helps bring mother and baby together — both physically and emotionally — until both are calm, which can initially take several hours and over time, minutes. FNI appears to help families — especially mothers — re-establish an emotional connection often interrupted by their babies' stressful and uncertain stay in a neonatal intensive care unit (NICU). In turn, both the infant and maternal nervous systems become better regulated, according to researchers. Babies born preterm can face a range of short-term and long-term challenges such as breathing problems due to an underdeveloped respiratory system, an increased risk of infection from an underdeveloped immune system, and learning difficulties, according to the Mayo Clinic. Many aspects of FNI are not new: The neonatal intensive care unit has long incorporated activities such as scent cloth exchanges, talking to the baby, and skin-to-skin contact. But the approach Welch and her colleagues advocate emphasizes building a bond between the mother and the infant. Mounting evidence shows that FNI can improve a wide range of outcomes for premature babies. In a 2021 study, for example, Welch's group showed that FNI was associated with lower heart rates among preemies in the NICU. A 2016 study linked the intervention to reduced depression and anxiety symptoms in mothers of preterm infants. And a 2015 randomized controlled trial showed FNI improved development and behavioral outcomes in infants up to 18 months. A new study published in Science Translational Medicine, showed that the intervention led to a greater likelihood that babies had improved cognitive development later on, narrowing the developmental gap between healthy, full-term babies.

FDA Panel Recommends Withdrawal of Makena for Preterm Birth

OCTOBER 28 2022

A federal advisory panel recommended the United States withdraw from the market an injection given to women at risk for giving birth prematurely. Many of its members argued this step is needed to allow further testing to see if this drug actually works. The Food and Drug Administration has been seeking to pull the approval of hydroxyprogesterone caproate (17P) injection (Makena, Covis) since 2020, after the drug failed to show a benefit in the PROLONG study. This study was meant as a confirmatory trial for the accelerated approval the FDA granted Makena in 2011 based on promising results from an earlier small study, known as the Meis trial. The manufacturer, Covis, contends that the flaws in the PROLONG study made Makena appear ineffective. The FDA asked its Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the evidence gathered to date on Makena at a hearing that ran from Oct. 17 to Oct. 19. At the conclusion, the FDA asked the committee to vote on whether the agency should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted. The vote was 14-1 against this plan. There needs to be another study as a "tiebreaker" to determine which of the previous Makena trials was correct, said FDA panelist Michael K. Lindsay, MD, MPH, who is also director of the division of maternal-fetal medicine for Grady and Emory University Hospital Midtown, Atlanta. "I think there needs to be another trial," Lindsay said. "If you can do the trial without the medication being FDA approved, then I am supportive of that." Members of the FDA panel noted the difficulties that would ensue if Covis attempted further study of Makena with the drug still approved, including difficulties in recruiting patients. Indeed, there were delays in recruiting patients for the PROLONG trial in part because Makena was perceived as the standard of care for pregnant women who had a prior spontaneous preterm birth. That led to efforts to enroll patients outside of the United States, particularly in Eastern European countries. Panelist Cassandra E. Henderson, MD, of the New York-based Garden OB/GYN practice, was the dissenter in the 14-1 vote. Withdrawing the approval of Makena may lead to increased use of pharmacy-compounded versions of this medicine, as women look for options to try to extend their pregnancies, she said. "They may seek it in other ways and get something that we don't have any control over, and we don't know what the fetus may be exposed to," Henderson said. Henderson also said there should be greater discussion with patients about questions of potential "intergenerational risk" because of fetal exposure to the medicine. Covis could add a registry similar to the University of Chicago's DES Program to its research program for Makena, she said.

Sentec and PyrAmes form partnership to bring noninvasive care to critically ill infants

OCTOBER 21 2022

Sentec and PyrAmes have established a commercial partnership to bring Boppli, PyrAmes’ first-of-its-kind continuous noninvasive blood pressure device, to neonatal intensive care teams throughout the United States. Boppli has received Breakthrough Device Designation from the US Food & Drug Administration (FDA) and will be available after FDA 510(k) clearance, which is anticipated in the first half of 2023. “We are excited to join forces with Sentec to commercialize our Boppli product,” said Xina Quan, PhD, Co-Founder and CEO of PyrAmes. “This important step enables us to bring our breakthrough technology to market and transform patient care. We believe Sentec is an ideal partner for us in the NICU, given our companies’ shared mission and focus on noninvasive technologies to enable better healthcare delivery.” In the neonatal intensive care unit (NICU) today, a baby’s blood pressure is either monitored continuously through an invasive arterial catheter or intermittently through cuff measurements. Both techniques present certain clinical challenges. The Boppli platform offers a new solution to overcome those challenges. “Blood pressures can be difficult to obtain with a cuff, especially in our tiny neonatal patients where the cuffs are too big which impacts accuracy. Arterial lines are the alternative, but any invasive line increases the risk of infection, so we are always trying to remove them earlier if we can. A non-invasive option that provides continuous, accurate measurements would be an important step forward so we can keep a close eye on our babies without causing them pain or overstimulation,” said Lamia Soghier, MD, MEd, MBA, Medical Director and Quality & Safety Officer of the NICU at Children’s National Hospital. Recent clinical research for neonates has highlighted the importance of neuroprotective care for premature infants, providing an optimal sensory environment for babies who should otherwise still be in utero. Everything from sound and light levels to the frequency of painful or stimulating procedures (such as blood draws, cuff measurements, suctioning, or even diapering) can impact proper neurological development. More and more, NICUs are creating quality care bundles with the goal of systematically providing neuroprotective care and improving neurological outcomes for their patients. Sentec’s flagship transcutaneous CO2 monitoring technology has been adopted by top NICUs around the world looking to keep a close eye on their patients’ respiratory status while limiting painful and invasive blood draws. The exclusive distribution partnership between PyrAmes and Sentec will allow Sentec customers to be among the first NICUs to adopt the Boppli solution. “We are humbled and enthusiastic about offering our healthcare customers yet another option for noninvasive monitoring that advances their goals of providing less invasive, more neuroprotective care in this critical and vulnerable patient population,” said Bob Cormier, President of Sentec North America. “We are confident that our partnership with PyrAmes will provide value to our companies, our customers, and most importantly, to patients.

Donation Helps Significantly Expand Capacity for Sickle Cell Disease Screening in Ghana

OCTOBER 14 2022

PerkinElmer Inc., a global leader committed to innovating for a healthier world, today announced the Company has donated to Ghana’s Health Services’ initiative to increase the country’s screening of newborns for sickle cell disease (SCD) from its current 4 percent of all babies born in the country to 50 percent by 2030. PerkinElmer’s contribution of easy-to-use, scalable laboratory solutions enables Noguchi Memorial Institute for Medical Research, University of Ghana to be a Center of Excellence and National Training Center for SCD newborn screening with the ability to build screening capacity for an additional 50,000 babies annually. The PerkinElmer-provided Migele Gel Electrophoresis Systems will support Ghana’s need for reliable, fast, and cost-efficient SCD screening. With the government’s desire to enact a country-wide screening program, the PerkinElmer solution’s flexible and scalable design can meet growing high-capacity requirements as screening coverage and sample volumes increase. “PerkinElmer is committed to helping the government of Ghana develop sustainable end to end solutions that focus on screening and diagnosis, in addition to comprehensive care for SCD,” said Marika Kase, business director, reproductive health at PerkinElmer. “We would like to congratulate Ghana Health Services and the Sickle Cell Foundation for the milestones gained so far, in advancing the diagnosis and care of patients with the disease in the country. We hope that this donation will facilitate development of Ghana’s SCD screening program and will therefore improve the lives of children in the region.” As part of its commitment to the Sub-Saharan African region, PerkinElmer, together with the Novartis Africa Sickle Cell Disease program, is aiming to expand advocacy efforts to educate patients, caregivers and communities about the importance of newborn screening and early intervention with hydroxyurea (HU) and other SCD treatments.

Study Finds Vat Pasteurization Retains Molecular Structure of Naturally Occurring Bioactive Proteins in Human Donor Milk

OCTOBER 14 2022

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced the publication of a journal article that compares the effects of various manufacturing methods on bioactive proteins in donor human milk. The naturally occurring bioactive proteins in human milk play a vital role in infant nutrition. In addition to providing key nutrients like amino acids, calcium, and phosphorus, bioactive proteins also protect against bacterial and viral infections and contain anti-inflammatory properties. The peer-reviewed article, which focuses on structural and functional changes of bioactive proteins, found that the molecular structure of bioactive proteins in donor human milk that had been vat pasteurized most closely resembled those in raw milk controls, compared with other human milk processing methods, including ultra-high-temperature (UHT) sterilization and retort sterilization. Authored by Ningjian Liang, PhD; David C. Dallas, PhD; and colleagues at Oregon State University and the University of California, Davis, "Structural and Functional Changes of Bioactive Proteins in Donor Human Milk Treated by Vat-Pasteurization, Retort Sterilization, Ultra-High-Temperature Sterilization, Freeze-Thawing and Homogenization" was published in September in the peer-reviewed journal Frontiers in Nutrition. The study compared the effects on human milk when treated by commonly used processing methods. The researchers concluded that different bioactive proteins have different sensitivity to the treatments tested. Overall, vat pasteurization preserved more of the bioactive proteins than UHT sterilization or retort sterilization did. This was especially true of three bioactive proteins: immunoglobulins, lactoferrin, and caseins. Intake of human milk is especially critical for babies born prematurely, with mother's own milk (MOM) being the best feeding option. When an adequate amount of MOM is not available, the American Academy of Pediatrics recommends the use of donor human milk. Donor human milk must be processed to eliminate the possibility of pathogen contamination before being given to infants in the neonatal intensive care unit (NICU). Once the milk is processed and/or pasteurized to ensure safety, bioactivity is impacted. But prior to this study, the extent of those changes based on each processing method were unknown. "Currently, donor milk processors lack information about the extent to which different processing techniques degrade or preserve bioactive milk proteins. Our study addresses this critical research gap as we examined the extent to which various treatments can preserve bioactive proteins," wrote Liang, a postdoctoral researcher in the laboratory of David Dallas, an assistant professor in the College of Public Health and Human Sciences at Oregon State University. "This information will support milk processors in determining how to optimally process donor milk to preserve specific milk proteins." Liang et al. tested processed milk samples using the SDS-PAGE method, which separates proteins based on their molecular weight. They then tested the milk samples using the enzyme-linked immunoabsorbent assay (ELISA), a widely used laboratory technique that measures proteins and other substances. "The more we learn about the importance of bioactivity in human milk, the more important it is that we understand how processing affects the milk we rely on to provide optimal nutrition to our patients," said Melinda Elliott, chief medical officer of Prolacta and a practicing neonatologist. "This study reinforces that how human milk is processed matters. Prolacta's human milk-based products are vat pasteurized to preserve as much of the natural bioactivity of the milk as possible."

Increased Risks for Newborns of Women With Disabilities

SEPTEMBER 30 2022

Babies of women with disabilities have a greater chance of experiencing rare health complications and requiring intensive care – though many of the health issues are preventable, according to a new study. “There's good evidence that, especially for preterm birth and low-birth-weight babies, better access to prenatal care can make a big difference,” says Hilary Brown, co-author of the paper and assistant professor in the department of health and society at the University of Toronto Scarborough. Published by the American Academy of Pediatrics, the study – one of the largest of its kind –found the greatest risks were in newborns of women with intellectual or developmental disabilities, and multiple disabilities. Researchers used data from the non-profit research institute ICES to look at all births in Ontario from 2003 to 2018. They compared the newborns of about 200,000 women diagnosed with a disability to the 1.5 million babies of women without disabilities. They also classified four types of disability in the mothers: physical; sensory; intellectual or developmental; and multiple disabilities. “Looking at different types of disabilities is important because when we think about making perinatal care more accessible, there's broad recommendations that can be made around physician training, but there's more specific recommendations we can make depending on the type of disability, such as making sure newborn intensive care units (NICUs) are physically accessible,” says Brown, who holds a cross appointment at the Dalla Lana School of Public Health and is an adjunct scientist at ICES and the Women’s College Research Institute at Women’s College Hospital.

Study Identifies Skin Biomarkers That Predict Newborn Eczema Risk

SEPTEMBER 30 2022

Researchers have identified an immune biomarker in newborns that can predict the subsequent onset and severity of paediatric atopic eczema, a new study presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress has shown. The Barrier dysfunction in Atopic newBorns (BABY) study analysed a cohort of 450 babies (300 term and 150 preterm newborns) to examine whether skin barrier and immune biomarkers could predict the onset and severity of eczema during the first 2 years of life. Both term and preterm babies with elevated levels of Thymus and Activation-Regulated Chemokine (TARC) at 2 months were found to be more than twice as likely to develop eczema by the age of 2 years. This increased risk was still prevalent after adjusting for parental atopy (where the immune system is more sensitive to allergic diseases) and filaggrin gene mutations, which is a major predisposing factor for eczema. The study found a positive association between the level of TARC and the severity of eczema. Researchers used tape strips to painlessly and non-invasively collect skin cells from the back of babies' hands at 0-3 days and 2 months in term children and from the skin between the shoulder blades at 2 months of age in preterm children. The strips were analysed for immune biomarkers and babies were followed up for the next 2 years. First author and co-researcher Dr Anne-Sofie Halling, from the Bispebjerg Hospital at the University of Copenhagen, commented "To our knowledge, this is the first to show that non-invasively collected skin biomarkers can be used to predict the subsequent onset and severity of paediatric atopic eczema." "The study will help us investigate and create future preventative strategies for children with elevated TARC levels to help stop the development of this common and debilitating disease, which is an exciting prospect." Eczema affects up to 20% of the paediatric population and diagnoses continue to rise. "The test is painless and easy to perform and can help us to identify skin changes that occur prior to the development of eczema, particularly for the most severe forms of the disease. This provides a window of opportunity to develop targeted trials and prevent cases of eczema from occurring", concluded Dr Anne-Sofie Halling.

Newborns Get Routine Heel Blood Tests, but Should States Keep Those Samples?

SEPTEMBER 17 2022

Close to 4 million babies are born in the United States every year, and within their first 48 hours nearly all are pricked in the heel so their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such a crucial public health measure that states typically require it and parents aren’t asked for their permission before it’s done. But the lab tests for newborn screenings generally don’t use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood spots,” as they’re called, often without parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of the material. Some states allow the blood spots to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has prompted lawsuits from parents who want to make those decisions themselves and who seek to protect their children’s medical and genetic information. In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who said they didn’t receive enough clear information to provide informed consent for the blood to be used in research the state might conduct. The fate of millions of additional blood spots stored by the state will be determined at trial. Philip L. Ellison, an attorney in Hemlock, Michigan, who is spearheading the suit, said he became aware of the issue when his son was born five years ago. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Ellison said, he was approached by a hospital staffer who asked whether he wanted to sign a consent form allowing the blood from Patton’s heel-stick test to be donated for research. The unexpected request set off alarm bells for Ellison. “We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time, he said, is difficult to know. “A program that first starts out for one purpose, to test for disease, has now crept into medical research and then to law enforcement,” he said. Michigan is the rare state that asks parents for permission to use leftover newborn blood spots in research. Most do not, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life are crucial.

EU Panel Backs New Drug for Infant Immunization of RSV

SEPTEMBER 17 2022

The European Medicines Agency's human medicines committee on Friday recommended marketing authorization for an immunization against respiratory syncytial virus (RSV) for newborns and infants. The agency's Committee for Medicinal Products for Human Use (CHMP) based its positive opinion for Beyfortus (nirsevimab) for prevention of lower respiratory tract infections linked to RSV, the leading cause of hospitalization among infants. The US Food and Drug Administration granted nirsevimab (MEDI8897 in the United States) a breakthrough therapy designation in February 2019, although the product is still in the clinical trials stage and has not received marketing approval. RSV is the leading cause of lower respiratory tract infections in infants, according to a press release from AstraZeneca and Sanofi, which are jointly developing the vaccine. Worldwide, acute lower respiratory infections associated with RSV account for about 1.4 million hospitalizations and 27,300 in-hospital deaths among infants under age 6 months annually, according to the World Health Organization. The highly contagious virus is also a concern for adults with compromised immune systems and older people with underlying health conditions, who are at increased risk for severe disease. Nirsevimab is a long-acting antibody given as a single intramuscular injection at a dose of 50 mg for infants with a body weight of less than 5 kg, and 100 mg for infants weighing at least 5 kg. The European authority based its positive opinion on results from several trials, including the phase 3 MELODY study of nearly 1500 infants, which reported a reduced incidence of medically attended lower respiratory tract infections associated with RSV with nirsevimab of 74.5% versus placebo (95% CI, 49.6, 87.1; P < .001).

Prolacta Bioscience Recognizes Nurses Caring for Fragile Infants Every Day

SEPTEMBER 12 2022

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, is celebrating National Neonatal Nurse's Week and NICU Awareness Month by recognizing the dedication of the neonatal intensive care unit (NICU) nurses who work tirelessly to care for the most fragile patients: premature infants. "NICU nurses work around the clock year-round to provide the best care to the tiniest, most vulnerable patients in the hospital," said Melinda Elliott, MD, chief medical officer at Prolacta. "We celebrate NICU nurses every day, but especially this month, and thank them for helping premature infants grow and thrive with an Exclusive Human Milk Diet including Prolacta's 100% human milk-based fortifiers." Established by the National Association of Neonatal Nurses (NANN) two decades ago, Neonatal Nurses Week 2022 is observed September 12-18 to celebrate the nurses who care for the medically fragile babies in the NICU. The week falls during NICU Awareness Month, which honors families with infants experiencing a stay in the NICU and the health professionals who care for them. Throughout Neonatal Nurses Week, Prolacta is recognizing NICU nurses with free educational offerings, such as CE-credited webinars to support the growth and health of premature infants in their care. Each day, Prolacta will provide a new resource to support NICU nurses in meeting the health and nutritional needs of premature infants. "All of us at Prolacta recognize and honor the critical role that NICU nurses play in caring for critically ill, premature infants," said Scott Elster, Prolacta's chief executive officer. "We are grateful for and inspired by their commitment to ensuring these infants receive the highest standard of care possible to give them the best chance at a bright and healthy future." The major difference between cow milk-based and human milk-based products is the composition — notably, the bioactive components that are unique to human milk. These include immunoglobulins, lactoferrin, milk fat globule membrane, and the wide spectrum of prebiotics known as human milk oligosaccharides (HMOs), which are not easily manufactured and thus are greatly decreased or missing from cow milk-based nutritional products. Bioactivity is thought to support infants' immunity, development, growth, and long-term health. Prolacta's 100% human milk-based nutritional products have the highest bioactivity in the human milk industry. Prolacta's nutritional products are vat pasteurized using profiles defined by the US Food and Drug Administration (FDA) to ensure pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible. Prolacta's vat pasteurized products retain higher bioactivity than products processed using other methods, including retort sterilization and ultra-high-temperature (UHT) processing.

AngelEye Health Introduces NICU Technology Conversion Team

SEPTEMBER 7 2022

AngelEye Health, a leading provider of family engagement solutions for hospital neonatal and pediatric intensive care units, announced the introduction of the company's inaugural NICU technology conversion team. Comprised of some of the healthcare organization's most seasoned onboarding specialists, the unit will help new customers navigate the process of converting from existing solutions to the AngelEye CameraSystem. Members of the dedicated integration team include project managers, clinical specialists, and systems analysts: Allison Hassett, Morgan Johnston, BSN, RN, Monique Landor, MSN, RNC-NIC, CLC, CPPS, Kyle Curry and Jonathan Fuchs "Exemplary customer support is the cornerstone of the AngelEye Health service offering and has been since day one," said Christopher Rand, CEO of AngelEye Health. "As our team continues to quickly add new hospital partners who are converting from other NICU camera solutions, we realized that some of their onboarding needs were unique. We saw an opportunity to proactively ensure that we had the resources in place to address any technical and clinical needs they may have. We are proud to introduce the industry's first NICU technology conversion team, purpose-built to support these transitions every step of the way." Patient and family engagement technology for hospital settings has been growing in acceptance as it presents NICUs and other pediatric units with additional opportunities to support families during their child's time in the hospital. It also fosters an instant and lasting bond with family members even when they can't be at the hospital. In response to this need, AngelEye developed a state-of-the-art CameraSystem™, which brings live-streaming video of the patient to family members anywhere, anytime, on any device. Web-camera technologies provide families with a unique opportunity to connect with their hospitalized children through interactive, real-time technologies. Thus, a cost-efficient pediatric webcam program like AngelEye Health's has the potential to improve the quality of life for participating families by relieving anxiety and cultivating a distant bonding experience. While the AngelEye onboarding process is always thorough and well-executed, customers who are already familiar with and reliant on cameras in their NICU can now benefit from a specialized level of solution migration support that is unique to their situation. As AngelEye continues to add conversion customers to its portfolio of hospital partners - and at an increasingly accelerated rate - introducing a team of professionals who are well versed in the technology conversion process can add a layer of technical and clinical support to ensure that the transition is seamless and the hospital's NICU care team is up and running on the system quickly and with minimal downtime. Arkansas Children's Hospital was one of AngelEye’s first NicView conversion projects which involved 90 cameras. Since day one of the technology migration, their hospital team has benefited from the cohesive support from AngelEye’s team of project managers, clinical specialists, and systems analysts, each dedicated to ensuring that the onboarding process was as streamlined and painless as possible. "AngelEye Health has been very accommodating and willing to work with us and tailor the entire camera system conversion to meet our needs," said Luann Jones, DNP, APRN, NNP-BC, NE-BC, formerly the neonatal services director, Arkansas Children's Hospital. "Every NICU is in a different place at different times, and there's not really a one size fits all approach. Their team was willing to collaborate with us as an institution and as a unit to figure out what really worked best to meet our needs." For hospitals and health systems interested in learning more about what their own camera system conversion might look like and how the AngelEye NICU technology conversion team can support them through every step of the process, please read the Top 10 Questions from Conversion Partners or schedule a call with one of AngelEye's Account Managers.

Vaccine Hopes for RSV, Leading Cause of Death in US Infants

AUGUST 30 2022

Respiratory syncytial virus (RSV) is the leading cause of US infant hospitalizations overall and across population subgroups, new data published in the Journal of Infectious Diseases confirm. Acute bronchiolitis caused by RSV accounted for 9.6% (95% confidence interval, 9.4%-9.9%) and 9.3% (95% CI, 9.0%-9.6%) of total infant hospitalizations from January 2009 to September 2015 and October 2015 to December 2019, respectively. The latest issue of the journal includes a special section with results from 14 studies related to the widespread, easy-to-catch virus, highlighting the urgency of finding a solution for all infants. In one study, authors led by Mina Suh, MPH, with EpidStrategies, a division of ToxStrategies in Rockville, Md., reported that, in children under the age of 5 years in the United States, RSV caused 58,000 annual hospitalizations and from 100 to 500 annual deaths from 2009 to 2019 (the latest year data were available). Globally, in 2015, among infants younger than 6 months, an estimated 1.4 million hospital admissions and 27,300 in-hospital deaths were attributed to RSV lower respiratory tract infection (LRTI). The researchers used the largest publicly available, all-payer database in the United States — the National (Nationwide) Inpatient Sample — to describe the leading causes of infant hospitalizations. The authors noted that, because clinicians don’t routinely perform lab tests for RSV, the true health care burden is likely higher and its public health impact greater than these numbers show. There are no preventative options currently available to substantially cut RSV infections in all infants, though immunization candidates are advancing, showing safety and efficacy in clinical trials. Palivizumab is currently the only available option in the United States to prevent RSV and is recommended only for a small group of infants with particular forms of heart or lung disease and those born prematurely at 29 weeks’ gestational age. Further, palivizumab has to be given monthly throughout the RSV season. Another of the studies in the journal supplement concluded that a universal immunization strategy with one of the candidates, nirsevimab (Sanofi, AstraZeneca), an investigational long-acting monoclonal antibody, could substantially reduce the health burden and economic burden for US infants in their first RSV season. The researchers, led by Alexia Kieffer, MSc, MPH, with Sanofi, used static decision-analytic modeling for the estimates. Modeled RSV-related outcomes included primary care and ED visits, hospitalizations, including ICU admission and mechanical ventilations, and RSV-related deaths. “The results of this model suggested that the use of nirsevimab in all infants could reduce health events by 55% and the overall costs to the payer by 49%,” the authors of the study wrote.

CDC Says More Is Needed to Protect Infants From Hepatitis B

AUGUST 15 2022

Progress has occurred in reducing maternal-to-child transmission of hepatitis B but is still lagging, particularly in Africa, according to a recent report from the Centers for Disease Control and Prevention (CDC) on maternal-to-child transmission (MTCT) of hepatitis B virus (HBV). By December 2020, 190 (98%) of 194 World Health Organization (WHO) member states had introduced universal infant vaccination with hepatitis B vaccine (HepB), four countries more than in 2016. During this period, there was a 10% increase in providing hepatitis B birth dose (HepB-BD) to all newborns within 24 hours of birth, up to 110 countries (57%). The slow increase suggests progress may have stalled, the authors write. In 2020, fewer than half of infants globally were given a HepB-BD shot. Rania Tohme, MD, MPH, the team lead of the Hepatitis B and Tetanus Team in the Global Immunization Division at the CDC, said: "There are still almost 50 countries that do not provide the hepatitis B birth dose, most of them in the African region…The coverage has dropped more recently in 2020 and 2021 as a result of the COVID 19 pandemic, which impacted the access and the use of healthcare services." She emphasized that Africa "has the highest prevalence of hepatitis B infection in children, over 4 million infected with hepatitis B, representing a 2.5% prevalence of chronic infection in children under 5, which is the highest among all regions globally." Other regions have less than 1% prevalence of hepatitis B in children. Yet, "despite the higher burden in the African region, it's still lagging behind in the introduction of the hepatitis B birth dose and HepB3," Tohme said. HBV is the leading cause of cirrhosis of the liver and liver cancer in adulthood. The scale of the problem is vast. If not prevented with vaccination, 90% of children will become infected at birth. There are currently 6.4 million young children with chronic HBV globally.

Death Risk Doubles for Black Infants With Bronchopulmonary Dysplasia

AUGUST 15 2022

Infants with bronchopulmonary dysplasia (BPD) who were born to Black mothers were significantly more likely to die or to have a longer hospital stay than infants of other ethnicities, based on data from more than 800 infants. The overall incidence of BPD is rising, in part because of improved survival for extremely preterm infants, wrote Tamorah R. Lewis, MD, of the University of Missouri, Kansas City, and colleagues. Previous studies suggest that racial disparities may affect outcomes for preterm infants with a range of neonatal morbidities during neonatal ICU (NICU) hospitalization, including respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis. However, the association of racial disparities with outcomes for preterm infants with BPD remains unclear, they said. In a study published in JAMA Pediatrics, the researchers, on behalf of the Bronchopulmonary Dysplasia Collaborative, reviewed data from 834 preterm infants enrolled in the BPD Collaborative registry from Jan. 1, 2015, to July 19, 2021, at eight centers in the United States. The study infants were born at less than 32 weeks’ gestation and were diagnosed with severe BPD according to the 2001 National Institutes of Health Consensus Criteria. The study population included 276 Black infants and 558 white infants. The median gestational age was 24 weeks, and 41% of the infants were female. The primary outcomes were infant death and length of hospital stay. Although death was infrequent (4% overall), Black maternal race was significantly associated with an increased risk of death from BPD (adjusted odds ratio, 2.1). Black maternal race also was significantly associated with a longer hospital stay for the infants, with an adjusted between-group difference of 10 days. Infants of Black mothers also were more likely than those with White mothers to receive invasive respiratory support at the time of delivery. Black infants were more likely than White infants to have lower gestational age, lower birth weight and length, and smaller head circumference. However, the proportions of cesarean deliveries, gender distribution, and infants small for gestational age were similar between Black and White infant groups. Medication exposure at 36 weeks postmenstrual age (PMA) also was similar for Black and White infants, and 50% of patients overall were treated with nasal continuous positive airway pressure at 36 weeks’ PMA. Awareness of the increased risk of death and longer hospital stay for Black infants is critical, “given the highly variable outcomes for patients with BPD and the uncertainty regarding demographic factors that contribute to late respiratory morbidity in severe BPD,” the researchers wrote.

Agency Donates Breathing Devices for Premature Babies to Ukraine

AUGUST 15 2022

Global health aid agency Unitaid is donating 220 specialised portable breathing devices to Ukraine that can help save lives of premature babies even in frontline hospitals where there is no electrical power. Russia's invasion of Ukraine on Feb. 24 has seen hundreds of hospitals damaged or destroyed, disrupting supply lines and placing newborn babies at risk of death or disability from a lack of access to equipment and oxygen. Herve Verhoosel, spokesperson for Unitaid, told a media briefing that the war was causing extra stress on pregnant women, leading to an increase in the number of premature births, which had tripled in some areas. The new bubble nasal continuous positive airway pressure (bCPAP) devices are now available in 25 facilities across Ukraine, Verhoosel said. Unitaid funds medical innovation programmes mainly in poor countries, and is hosted by the World Health Organization.

COVID-19 Infection Late in Pregnancy Linked to Sevenfold Risk for Preterm Birth

AUGUST 15 2022

Pregnant women who get infected with SARS-CoV-2 in their third trimester are almost three times as likely to have a preterm birth, while infection after 34 weeks’ gestation raises this risk sevenfold, based on the largest matched population-based cohort study published to date. These findings support previous studies, underscoring the need for pregnant women and their families to take preventive measures against infection, lead author Noga Fallach, MA, of the Kahn-Sagol-Maccabi Research and Innovation Center, Tel Aviv, and colleagues reported. Past research has suggested that COVID-19 may cause low birth weights and preterm birth in pregnant women, but those studies didn’t report outcomes for each trimester, the investigators wrote in PLoS ONE, noting that “timing of viral infection during fetal development may affect birth and other health outcomes.” To address this knowledge gap, the investigators looked back at data from 2,703 pregnant women in Israel who tested positive for SARS-CoV-2 from Feb. 21, 2020, to July 2, 2021. Pregnancy outcomes in these women were compared with outcomes in an equal number of uninfected pregnant women. Vaccination status was not reported. Comparing the two groups showed that catching COVID-19 in the third trimester was linked with nearly triple the risk of preterm birth (odds ratio, 2.76; 95% confidence interval, 1.63-4.67), and more than quadruple the risk if COVID-19 symptoms were present (OR, 4.28; 95% CI, 1.94-9.41). Women who tested positive for SARS-CoV-2 after 34 weeks’ gestation were seven times more likely than uninfected women to deliver early (OR, 7.10; 95% CI, 2.44-20.61). Pregnant women who caught COVID-19 in the first two trimesters were not significantly more likely to have a preterm birth. Infection was not associated with abnormally low birth rates, or pregnancy loss, in any trimester.

Prolacta Names New Director of Clinical Education

AUGUST 2 2022

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced that neonatologist and breastfeeding advocate Erin Hamilton Spence, MD, IBCLC, has been appointed director of clinical education and professional development. Hamilton Spence brings more than 14 years of clinical experience as a board-certified neonatologist and lactation consultant to Prolacta's Medical Science Liaison team, having practiced at multiple hospital neonatal intensive care units (NICUs), including Cook Children's Medical Center and Baylor Scott & White Health-Andrews Women's Hospital. At Pediatrix Medical Group of Texas, Hamilton Spence has been an attending neonatologist and lead physician for the breast milk continuous quality improvement (CQI) initiative. At Cook Children's Medical Center, Hamilton Spence currently chairs the Department of Critical Care. She founded the Gastrointestinal Rehabilitation Adaptive Care & Education (GRACE) team in 2020. Since 2010, Hamilton Spence has also served as associate medical director of the NICU at Baylor Scott & White Health- Andrews Women's Hospital leading QI efforts, including as lead physician for multidisciplinary round as well as its Uber Preemie Team, caring for infants less than or equal to 24 weeks gestation, since 2016. "Dr Erin Hamilton Spence is an experienced neonatologist with a demonstrated history of clinical leadership in some of the country's top NICUs," said Melinda Elliott, MD, chief medical officer at Prolacta. "Her extensive NICU and milk banking experience makes her perfect for the role of educating other neonatologists about the importance of an Exclusive Human Milk Diet (EHMD). Her leadership will be key to ensure that more critically ill, premature infants can benefit from human milk when they need it most." A noted human milk researcher, Hamilton Spence has authored or co-authored studies published in the Journal of Perinatology, PLOS One, Gut, and the Journal of Human Lactation. She has presented her work at numerous conferences, including those of the Academy of Breastfeeding Medicine, the Pediatric Academic Societies, the American College of Obstetrics and Gynecology, and the Human Milk Banking Association of North America. Hamilton Spence holds an academic appointment as a clinical assistant professor at Texas Christian University School of Medicine. She served as the co-medical director and past president of the Mother's Milk Bank of North Texas and is a member of the Texas Breastfeeding Coalition. Additionally, Hamilton Spence serves on the faculty of both the Scott & White Annual Neonatology (SWAN) Conference and the NEO Conference. "I'm honored to join Prolacta's Medical Science Liaison team. I've witnessed the lifesaving value of Prolacta's products in our NICUs. This position for Prolacta marries all my strongest interests in human milk nutrition research, education, and quality," Hamilton Spence said. "Prolacta has led the way in advancing human milk-based nutritional care for premature infants in the NICU, and I am thrilled to make a difference beyond my own NICU for the most vulnerable infants and their families." A fellow of the Academy of Breastfeeding Medicine and the American Academy of Pediatrics, Hamilton Spence completed her fellowship and pediatrics residency at the University of Texas Health Science Center – Houston. She graduated from medical school at the University of Texas Medical Branch in Galveston.

Nurse Midwives Step Up to Provide Prenatal Care After Two Rural Hospitals Shutter Birthing Centers

JULY 29 2022

Eleven certified nurse midwives from the University of Iowa travel regularly to Muscatine and Washington, another southeastern Iowa town where the local hospital closed its birthing unit. The university’s pilot project, which is supported by a federal grant, doesn’t aim to reopen shuttered birthing units. Instead, the midwife team helps ensure area women receive related services. Last year, it served more than 500 patients in Muscatine and Washington. Muscatine is one of hundreds of rural areas in the U.S. where hospitals have dropped birthing services during the past two decades, often because they lack obstetricians and other specialized staff members. Hospital industry leaders say birthing units also tend to lose money, largely because of low payments from Medicaid, the public health insurance program that covers more than 40% of births in the U.S. and an even greater share in many rural areas. The loss of labor-and-delivery services hits especially hard for women who lack resources and time to travel for care. Muscatine, which is on the Mississippi River, has more than 23,000 residents, making it a relatively large town by Iowa standards. But its hospital is one of 41 Iowa facilities that have closed their birthing units since 2000, according to the Iowa Department of Public Health. Most were in rural areas. Just one has reopened, and only 56 Iowa hospitals now have birthing units. The nurse midwife team’s work includes crucial prenatal checkups. Most pregnant people are supposed to have a dozen or more such appointments before giving birth. Health care providers use the checkups to track how a pregnancy is progressing and to watch for signs of high blood pressure and other problems that can lead to premature births, stillbirths, or even maternal deaths. The midwives also advise women on how to keep themselves and their babies healthy after birth.

COVID-19 Infection Late in Pregnancy Linked to Sevenfold Risk for Preterm Birth

JULY 29 2022

Pregnant women who get infected with SARS-CoV-2 in their third trimester are almost three times as likely to have a preterm birth, while infection after 34 weeks’ gestation raises this risk sevenfold, based on the largest matched population-based cohort study published to date. These findings support previous studies, underscoring the need for pregnant women and their families to take preventive measures against infection, lead author Noga Fallach, MA, of the Kahn-Sagol-Maccabi Research and Innovation Center, Tel Aviv, and colleagues reported. Past research has suggested that COVID-19 may cause low birth weights and preterm birth in pregnant women, but those studies didn’t report outcomes for each trimester, the investigators wrote in PLoS ONE, noting that “timing of viral infection during fetal development may affect birth and other health outcomes.” To address this knowledge gap, the investigators looked back at data from 2,703 pregnant women in Israel who tested positive for SARS-CoV-2 from Feb. 21, 2020, to July 2, 2021. Pregnancy outcomes in these women were compared with outcomes in an equal number of uninfected pregnant women. Vaccination status was not reported. Comparing the two groups showed that catching COVID-19 in the third trimester was linked with nearly triple the risk of preterm birth (odds ratio, 2.76; 95% confidence interval, 1.63-4.67), and more than quadruple the risk if COVID-19 symptoms were present (OR, 4.28; 95% CI, 1.94-9.41). Women who tested positive for SARS-CoV-2 after 34 weeks’ gestation were seven times more likely than uninfected women to deliver early (OR, 7.10; 95% CI, 2.44-20.61). Pregnant women who caught COVID-19 in the first two trimesters were not significantly more likely to have a preterm birth. Infection was not associated with abnormally low birth rates, or pregnancy loss, in any trimester.

Moms' Cooing Swapped With Morphine for Newborns in Withdrawal

JULY 29 2022

Four years ago, Atrium Health, in Charlotte, North Carolina, embarked on a dramatic change in how it cares for newborns exposed to opioids in the womb. Until then, most of the 700 or so babies who underwent opioid withdrawal each year in the hospital system spent their first weeks in a neonatal intensive care unit (NICU), isolated from their parents and treated with regular doses of morphine to ease their symptoms. Now, most babies stay in the hospital for just a few days under a new approach called Eat, Sleep, Console. These young patients stay in private rooms where they can bond with their parents and volunteer caregivers. The usual course of treatment is no longer extended therapy with opioid replacements. Instead, mothers are encouraged to stay overnight and are taught how to sooth their babies with swaddling, rocking, and cooing. As a result, the average length of stay for newborns with neonatal abstinence syndrome (NAS) has dropped from 12 days to 6. Use of morphine has fallen by 79%, from 2.25 to 0.45 mg/kg per stay, according to results of a quality improvement pilot project at one of Atrium's community hospitals.

Similar outcomes from other hospitals around the country have led to widespread uptake of Eat, Sleep, Console since its advent in 2017. That year, according to federal data, seven newborns were diagnosed with NAS for every 1000 births. Advocates say the family-centric model helps parents feel less stigmatized and more confident in their ability to care for their babies, who can have symptoms such as irritability and difficulty feeding for months.

Studies Show Prolacta's 100% Human Milk-Based Nutritional Fortifiers Reduce Risk of Life-Threatening Comorbidities

JULY 29 2022

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, reports that data from a growing body of peer-reviewed clinical studies show a reduced risk of several comorbidities among premature infants who received Prolacta's 100% human milk-based fortifiers as part of Exclusive Human Milk Diet (Prolacta's EHMD), compared to premature infants fed cow milk-based fortifiers. "Premature infants are susceptible to life-threatening complications that risk not only their very survival but also their long-term health and development," said Melinda Elliott, MD, FAAP, and chief medical officer of Prolacta. "Multiple peer-reviewed studies found that Prolacta's nutritional fortifiers, when used as part of an EHMD, play an integral role in helping reduce rates of the most common comorbidities in these fragile infants while also improving their long-term neurodevelopment." Neonatal intensive care units (NICUs) worldwide are working to reduce complications in premature infants. Mounting clinical evidence shows that replacing cow milk-based fortifiers with Prolacta's EHMD delivers the concentrated nutrition premature infants need to promote adequate growth and development, increases feeding tolerance, and reduces several of the most serious complications, including bronchopulmonary dysplasia (BPD), late-onset sepsis, necrotizing enterocolitis (NEC), and retinopathy of prematurity (ROP). An infant's lungs are among the last organs to fully develop inside the womb, leaving many premature infants at high risk of developing BPD. BPD is also called chronic lung disease (CLD) of prematurity. It is one of the most serious complications of prematurity and can cause respiratory morbidity, longer hospital stays, and long-term neurodevelopmental impacts. The longer a premature infant receives supplemental oxygen or mechanical ventilation, the higher the risk of developing BPD. Several studies have reported significant decreases (weighted average of 9.7%) in the incidence of BPD in premature infants fed Prolacta's EHMD compared to those fed cow milk-based nutritional products. Another study revealed that time is of the essence: Early fortification with Prolacta's fortifiers as part of an EHMD led to a 15% reduction in the incidence of BPD, compared with late fortification. Late-onset sepsis is a dangerous systemic infection with subsequent inflammatory response and the leading cause of mortality in NICUs. It is estimated that premature infants have up to a 26% chance of developing this serious complication. Late-onset sepsis is associated with several potential complications, including increased ventilation use, neurodevelopmental disabilities, predisposition to other comorbidities like BPD and ROP, longer NICU stays, and higher NICU costs. Several studies show that premature infants fed Prolacta's EHMD are less likely to develop late-onset sepsis than those fed cow milk-based fortifiers. NEC is a serious intestinal disease among extremely preterm infants (those born < 28 weeks gestational age) and is one of the leading causes of mortality among these very fragile, young patients. NEC is especially prevalent in premature infants who are fed cow milk-based fortifiers. Mortality for premature infants with NEC requiring surgical intervention can be as high as 34.9%, and 20.3% mortality in infants with medical NEC. Several studies have reported that premature infants who received Prolacta's EHMD instead of cow milk-based fortifiers have a reduced incidence of medical NEC or surgical NEC. ROP is an eye disease primarily affecting premature infants that results in abnormal development of retinal blood vessels. Between 40% and 80% of preterm infants develop ROP, making it a leading cause of blindness and decreased vision in children worldwide with a direct impact on neurodevelopment. Multiple studies have shown that infants fed Prolacta's EHMD have lower incidence and/or severity of ROP than those who are fed cow milk-based fortifiers. "The significant body of clinical evidence supporting short- and long-term health benefits with the use of an EHMD with Prolacta's fortifiers is encouraging and positively impacts not only the infants but also their families, communities, and the health system as a whole," said Scott Elster, president and CEO of Prolacta. "Addressing premature infant complications through nutrition in the NICU means getting these babies home sooner and healthier, and ultimately reducing hospital costs." The major difference between cow milk-based and human milk-based products is the composition — notably, the bioactive components that are unique to human milk. These include immunoglobulins, lactoferrin, milk fat globule membrane, and the wide spectrum of prebiotics known as human milk oligosaccharides (HMOs), which are not easily manufactured and thus are greatly decreased or missing from cow milk-based nutritional products. Bioactivity is thought to support infants' immunity, development, growth, and long-term health. Prolacta's 100% human milk-based nutritional products have the highest bioactivity in the human milk industry. Prolacta's nutritional products are vat pasteurized using profiles defined by the U.S. Food and Drug Administration (FDA) to ensure pathogen inactivation and the highest level of safety while retaining as much of the natural bioactivity of the milk as possible. Prolacta's vat pasteurized products retain higher bioactivity than products processed using other methods, including retort sterilization and ultra-high-temperature (UHT) processing.

Partnership to Enhance Neonatal Intensive Care Clinical Workflows and Patient Outcomes

JUNE 30 2022

Etiometry, a leader in clinical decision-support software for critical care, and Radiometer, a leading medical device company specializing in acute care testing solutions, announced a new collaboration to enhance the clinical workflows in Neonatal Intensive Care Units (NICU). The partnership pairs Etiometry’s platform to create a holistic view of the patient’s clinical picture empowering rapid, informed decision-making with Radiometer’s Transcutaneous Monitoring (TCM) solution, focused on monitoring ventilation of neonatal patients. Integrating the Etiometry platform with Radiometer’s real-time Transcutaneous Monitoring solutions will allow clinicians across the care continuum to view carbon dioxide trends with other physiologic parameters consolidated on one screen to streamline patient care management. The data will also help fuel clinical research activities by Etiometry and Radiometer aimed to demonstrate the minimization of ventilation times and improve extubation failure rates, with the goal to help reduce the time a patient needs to spend in the NICU as well as the associated costs of long NICU stays. The first phase of the partnership will validate proof of concept. “The care that neonates receive in the first hours and days of their life can have a significant impact on their quality of life,” said Henrik Schimmell, President and CEO of Radiometer. “Supporting caregivers in making well-informed treatment decisions is therefore crucial, and this partnership with Etiometry has the potential to make it easier for clinicians to provide the right treatment at the right time.” Etiometry’s platform enables hospitals to embed their specific clinical protocols and workflows into the software, automatically screening all patients for eligibility and tracking performance once a protocol is initiated. Incorporating Radiometer’s transcutaneous monitoring data into the Etiometry platform can further reduce the burden of manual protocol management. “Etiometry brings deep expertise in managing data analytics with our Clinical Decision Support platform that modernizes clinical workflow management and associated patient care activities through its customizable Clinical Management Application,” said Shane Cooke, CEO of Etiometry. “This partnership with Radiometer propels our ability to serve our customers with the essential patient data they need to make informed care decisions.”

In Utero COVID Exposure Tied to Neurodevelopmental Disorders at 1 Year

JUNE 30 2022

Infants exposed to SARS-CoV-2 in utero are at increased risk for neurodevelopmental disorders in the first year of life, new research suggests. But whether it is exposure to the pandemic or maternal exposure to the virus itself that may harm early childhood neurodevelopment is unclear, caution investigators, led by Roy Perlis, MD, MSc, with Massachusetts General Hospital, Boston. "In this analysis of 222 offspring of mothers infected with SARS-CoV-2, compared with the offspring of 7550 mothers in the control group (not infected) delivered during the same period, we observed neurodevelopmental diagnoses to be significantly more common among exposed offspring, particularly those exposed to third-trimester maternal infection," they write. The study included 7772 mostly singleton live births across six hospitals in Massachusetts between March and September 2020, including 222 (2.9%) births to mothers with SARS-CoV-2 infection confirmed by polymerase chain reaction testing during pregnancy. In all, 14 of 222 children born to SARS-CoV-2-infected mothers (6.3%) were diagnosed with a neurodevelopmental disorder in the first year of life vs 227 of 7550 unexposed offspring (3%) (unadjusted odds ratio [OR], 2.17; 95% CI, 1.24 - 3.79; P = .006). In models adjusted for preterm delivery, as well as race, ethnicity, insurance status, child sex and maternal age, COVID-exposed offspring were significantly more likely to receive a neurodevelopmental diagnosis in the first year of life (adjusted OR, 1.86; 95% CI, 1.03 - 3.36; P = .04). The magnitude of the association with neurodevelopmental disorders was greater with third-trimester SARS-CoV-2 infection (adjusted OR, 2.34; 95% CI, 1.23 - 4.44; P = .01). The majority of these diagnoses reflected developmental disorders of motor function or speech and language.

The researchers note the finding of an association between prenatal SARS-CoV-2 exposure and neurodevelopmental diagnoses at 12 months are in line with a "large body of literature" linking maternal viral infection and maternal immune activation with offspring neurodevelopmental disorders later in life. They caution, however, that whether a definitive connection exists between prenatal SARS-CoV-2 exposure and adverse neurodevelopment in offspring is not yet known, in part because children born to women infected in the first wave of the pandemic haven't reached their second birthday — a time when neurodevelopment disorders such as autism are typically diagnosed. There is also the risk for ascertainment bias arising from greater concern for offspring of infected mothers who were ill during pregnancy. These parents may be more inclined to seek evaluation, and clinicians may be more inclined to diagnose or refer for evaluation, the researchers note.

Milk Allergy Frequently Overdiagnosed

JUNE 30 2022

Many infants in some countries are misdiagnosed with allergy to cow, sheep, or goat milk, and they're prescribed specialized formulas they don't need, according to a consensus study. "Milk allergy overdiagnosis is common in some regions and can potentially harm mothers and infants," the authors write in Clinical & Experimental Allergy. "These new consensus recommendations on the safe detection and management of milk allergy in children under 2 years aim to reduce harms associated with milk allergy overdiagnosis."

"This guidance, developed by experts without commercial ties to the formula industry, aims to reduce milk allergy overdiagnosis and [to] support…breastfeeding and less use of specialized formula, compared with current guidelines," they add. Up to 1% of European infants 2 years of age and younger are considered allergic to cow's milk. Prescriptions for specialized formula for bottle-fed infants allergic to cow's milk in Australia, England, and Norway have grown to over 10 times the expected volumes. Lead study author Hilary I. Allen, National Heart and Lung Institute, Imperial College London, United Kingdom, and her colleagues on several continents developed practical guidance for providers on safely detecting and managing milk allergy in infants. Due to lack of high-certainty research evidence in this area, they used the Delphi consensus method. The study involved two rounds of anonymous consensus-building surveys and one formal meeting in 2021. The team identified experts from diverse geographic and cultural settings by searching medical databases for the term "milk hypersensitivity." They asked those experts to recommend colleagues. The researchers also contacted experts with ties to international professional organizations, such as the International Board of Lactation Consultant Examiners, as well as societies associated with the World Allergy Organization.

Best Practices Award Honors Commitment to Neonatal/Respiratory Care

JUNE 21 2022

Dräger, an international leader in the fields of medical and safety technology, announced that Frost & Sullivan has selected the company for its 2022 Global New Product Innovation Leadership Award in the categories of neonatal and respiratory care. Dräger was the recipient of Frost & Sullivan’s Global Technology Innovation Leadership Award for mechanical ventilation in 2014, 2017, and 2020, which are consecutive evaluation periods in this specific category. It remains unmatched in achieving this level of recognition as a single company during this time-period. Frost & Sullivan’s award criteria evaluate companies on their devices and the overall value they deliver to healthcare. Reflective of this year’s award, Dräger’s approach goes beyond its extensive expertise and best-in-class capabilities, with customer value as a strategic imperative. “Healthcare executives are looking for value beyond devices to support care delivery in the NICU and critical care environments,” said President and CEO for Draeger, Inc., Lothar Thielen. “This award validates our approach of combining best-in-class products, cost-effective accessories, and service solutions that deliver unmatched value for our hospital customers.” Frost & Sullivan applauded Dräger’s focus on improving outcomes for a baby’s neonatal intensive care unit (NICU) stay, highlighting the NICU by Dräger concept, which is designed to achieve this goal. Through this single, comprehensive solution, Dräger supports clinicians in delivering flexible, family-oriented, and patient-centric care, providing best-in-class neonatal ventilation and lung protection solutions, thermoregulation, jaundice phototherapy devices, and neonatal care accessories, along with expert NICU design and workflow consultancy. “Dräger’s new and purpose-built solution suite for neonatal care sets it apart from its competitors, with superior design, reliability, and quality as its central pillars,” the award text reads. In its research, Frost & Sullivan noted a key differentiator for the company; its commitment to supporting customers’ paths toward clinical needs, “Unlike competitors, Dräger builds its products by collaborating closely with a range of stakeholders and partners to evolve alongside market needs and trends. It works with leading physicians leveraging its advisory board, product managers, and research and development team to interact with key opinion leaders around the globe to understand the actual customer and market demands.” The award also honors Dräger’s commitment to continuing education. Dräger’s “A Breath Ahead” portal provides clinicians access to live and online continuing respiratory care education (CRCE) courses. Through its INSIGHTS program, Dräger shares ideas and innovations that can help hospitals achieve their goals by improving clinical outcomes, managing the cost of care, ensuring staff satisfaction, and enhancing the patient experience. “Dräger maximizes patient outcomes by improving safety, increasing the education level for clinicians, streamlining supply chain issues, and creating cost-effective and reliable biomedical solutions,” said Bhaskar Vittal, industry principal for Frost & Sullivan. “Everything that makes a healthier hospital in terms of patients’ safety, costs and outcomes for customers are the reasons driving Dräger’s successful momentum and continuous development over decades.”

PerkinElmer and Novartis Collaborate to Address the Unmet Need of Sickle Cell Disease in Sub-Saharan Africa

JUNE 17 2022

PerkinElmer Inc., a global leader committed to innovating for a healthier world, today announced that it is collaborating with Novartis, a leading global medicines company, to expand newborn screening for sickle cell disease (SCD) in sub-Saharan Africa. PerkinElmer together with the Novartis Africa Sickle Cell Disease program aims to expand advocacy efforts to educate patients, caregivers and communities about the importance of newborn screening and early intervention with hydroxyurea (HU) and other SCD treatments. Newborn screening for SCD and comprehensive disease management in high-income countries like the United States has reduced mortality in children under five years old by 94%. Yet, in sub-Saharan Africa which bears the highest burden of the disease, no national newborn screening program exists. This collaboration aims to galvanize governments to provide universal newborn screening as part of national health programs in support of early diagnosis and comprehensive interventions such as prophylactic penicillin, a pneumococcal vaccination and therapies like HU. With effective screening and management of SCD, governments could save many precious lives. The Novartis Africa Sickle Cell Disease program was launched in Ghana in 2019 as an end-to-end effort that encompasses SCD screening, diagnosis, treatment, education, research and advocacy. Today this unique program has been expanded to Uganda, Tanzania, Kenya and Zambia, with plans to reach a total of 10 countries. Among its varied contributions to the program, PerkinElmer will work toward strengthening existing SCD programs by providing training, consultations, support and related services to health care professionals and lab technicians across participating countries in sub-Saharan Africa. The Company will also help establish new lab facilities to build capacity for SCD screening in participating countries. “As a global leader in newborn screening solutions we are pleased to be working with Novartis to assist people across sub-Saharan Africa affected by this condition,” said Petra Furu, general manager, reproductive health at PerkinElmer. “By building awareness around the importance of newborn screening, our hope is that more babies receive an early diagnosis that leads to earlier treatment – ensuring they have the best possible chance of a healthy start to life.” “This collaboration with PerkinElmer reaffirms our commitment to reimagining care for sickle cell disease patients, by accelerating access to national newborn screening and hydroxyurea through public-private partnerships with local governments and other organizations,” said Racey Muchilwa, Country President and the Head of Novartis sub-Saharan Africa. “We will also be educating patients, caregivers and communities on the importance of newborn screening, early intervention and treatments while elevating the capacity for healthcare professionals to address the high unmet need of SCD.” In an initiative announced in March 2021, PerkinElmer works alongside the American Society of Hematology and its Consortium on Newborn Screening in Africa (CONSA) to provide resources for SCD screening programs in countries throughout sub-Saharan Africa, including Ghana, Kenya, Nigeria, Uganda, Zambia, Liberia and Tanzania. Novartis announced its partnership with ASH in early June, which will advance ASH’s CONSA objectives to demonstrate the benefits of newborn screening and early interventions for children with SCD and create a sustainable infrastructure for SCD newborn screening.

In Utero COVID Exposure Tied to Neurodevelopmental Disorders at 1 Year

JUNE 15 2022

Infants exposed to SARS-CoV-2 in utero are at increased risk for neurodevelopmental disorders in the first year of life, new research suggests. But whether it is exposure to the pandemic or maternal exposure to the virus itself that may harm early childhood neurodevelopment is unclear, caution investigators, led by Roy Perlis, MD, MSc, with Massachusetts General Hospital, Boston. "In this analysis of 222 offspring of mothers infected with SARS-CoV-2, compared with the offspring of 7550 mothers in the control group (not infected) delivered during the same period, we observed neurodevelopmental diagnoses to be significantly more common among exposed offspring, particularly those exposed to third-trimester maternal infection," they write. The study included 7772 mostly singleton live births across six hospitals in Massachusetts between March and September 2020, including 222 (2.9%) births to mothers with SARS-CoV-2 infection confirmed by polymerase chain reaction testing during pregnancy. In all, 14 of 222 children born to SARS-CoV-2-infected mothers (6.3%) were diagnosed with a neurodevelopmental disorder in the first year of life vs 227 of 7550 unexposed offspring (3%) (unadjusted odds ratio [OR], 2.17; 95% CI, 1.24 - 3.79; P = .006). In models adjusted for preterm delivery, as well as race, ethnicity, insurance status, child sex and maternal age, COVID-exposed offspring were significantly more likely to receive a neurodevelopmental diagnosis in the first year of life (adjusted OR, 1.86; 95% CI, 1.03 - 3.36; P = .04). The magnitude of the association with neurodevelopmental disorders was greater with third-trimester SARS-CoV-2 infection (adjusted OR, 2.34; 95% CI, 1.23 - 4.44; P = .01). The majority of these diagnoses reflected developmental disorders of motor function or speech and language.

Vaccines in Pregnancy Reduce Infants' COVID-19 Risk

JUNE 15 2022

COVID-19 vaccination during pregnancy appears to lower newborns' risk of coronavirus infection, according to a study conducted in Norway. Norwegian researchers tracked 9,739 babies whose mothers received a second or third dose of a COVID-19 vaccine from Pfizer (PFE.N)/BioNTech (22UAy.DE) or Moderna (MRNA.O) while pregnant, and 11,904 babies whose mothers were not vaccinated before or during pregnancy. Overall, COVID infections were rare in the babies. But the risk of a positive COVID-19 PCR test during the first four months of life was 71% lower during the Delta era and 33% lower when Omicron was dominant for babies whose mothers got vaccinated during pregnancy compared with infants born to unvaccinated mothers, the researchers reported.

Pregnant Women With Monkeypox Advised to Have C-Section

JUNE 15 2022

Pregnant women with monkeypox will be advised to give birth by C-section to avoid infecting their baby during delivery, according to a new paper in Ultrasound in Obstetrics & Gynecology. The risk of monkeypox infection remains low for the general public, the authors wrote, though cases continue to grow worldwide, particularly in the U.K. “We are aware infants and children are at greater risk of becoming seriously ill if they do catch monkeypox,” Edward Morris, one of the authors and president of the Royal College of Obstetricians and Gynecologists, said in a statement. “Therefore, to minimize the risk of a baby contracting the virus, we recommend healthcare professionals discuss the benefits and risks of having a caesarean birth with a pregnant women or person who has or is suspected of having the virus,” he said. Morris and colleagues pulled together existing evidence on monkeypox diagnosis, treatment, and recommended modes of birth for mothers and babies. “The World Health Organization states there could be adverse consequences for pregnant women and babies if they become infected, including congenital monkeypox, miscarriage, or stillbirth, which is why we have provided clear guidance for healthcare professionals in this paper,” Morris said. The monkeypox virus typically spreads through direct contact, droplets, or contaminated surfaces and objects. But some limited evidence shows that the virus can be passed from a mother to a baby via the placenta, which can lead to congenital monkeypox.

Prolacta Bioscience Introduces Its First Evidence-Based Feeding Protocol for an Exclusive Human Milk Diet in the NICU

JUN 15 2022

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, today announced the introduction of the first evidence-based feeding protocol for the use of an Exclusive Human Milk Diet including Prolacta's products (Prolacta's EHMD) in the neonatal intensive care unit (NICU). Prolacta's EHMD Protocol addresses the nutritional risks of late and inadequate nutrition facing low birth weight premature infants and is the first nutritional guidance issued for the use of the company's human milk-based nutritional products. Developed in conjunction with independent clinicians, registered dieticians, nurses, and neonatologists, Prolacta's EHMD Protocol is backed by 15 years of clinical experience and more than 20 clinical studies. The protocol presents additional perspective on the standard of care in NICUs that can help premature infants avoid complications and reach key growth goals. "This protocol provides best-practice guidance to members of the NICU team as we tailor nutrition to each infant's needs and risk factors," said Rangasamy Ramanathan, MD, professor of pediatrics, division chief, Division of Neonatal Medicine, LAC+USC Medical Center. "A standardized feeding approach for an EHMD with human milk-based products helps eliminate the uncertainty in meeting infants' protein goals to achieve adequate growth with fewer complications." Prolacta's EHMD Protocol supports clinicians in delivering the optimal nutrients to fragile infants at the optimal time — helping as they work to achieve better health outcomes lower hospital costs, and significantly reduce the risk of complications and feeding intolerance associated with cow milk-based fortifiers. Over the past 15 years, more than 20 clinical studies involving more than 5,000 premature infants have shown that hospitals with the best outcomes followed similar feeding practices with the use of Prolacta's fortifiers.1 Inversely, it is proven that delayed fortification leads to less-optimal results in critically ill, premature infants. An EHMD is achieved when 100% of the protein, fat, and carbohydrate in an infant's diet are derived from human milk. An EHMD with Prolacta's 100% human milk-based fortifiers, compared with the use of cow milk-based fortifiers or formula, is known to reduce the risk of severe complications and feeding intolerance in preterm infants. For years, the risks associated with cow milk-based fortifiers left healthcare professionals in the NICU cautious about starting fortification too early. With Prolacta's EHMD Protocol, clinicians can safely begin fortification as early as the first week of an infant's life, confident that issues such as feeding intolerance and other complications have been shown to be significantly reduced. "Prolacta's EHMD Protocol can reduce the incidence of comorbidities, support adequate growth, and improve mortality rates, offering groundbreaking benefits for this fragile patient population," said Melinda Elliott, MD, FAAP, and chief medical officer at Prolacta. "Even the most vulnerable infants born weighing less than 750 g have been shown to greatly benefit from an EHMD, giving them the best chance for a healthy, bright future." To help meet each patient's unique needs, Prolacta's EHMD Protocol is designed to provide flexible feeding advancement based on each premature infant's weight, clinical status, and health risk factors. Prolacta's EHMD Protocol supports adequate growth with fewer complications as measured by increases in length, head circumference, and weight. These gains lower the risk of long-term metabolic morbidities including obesity, diabetes, and cardiovascular disease. Research has shown that Prolacta's fortifiers, when used as part of an EHMD, support healthy body composition with improvements in lean body mass, normal total body fat, and adequate bone mineralization. Furthermore, for premature infants fed an EHMD, the benefits of appropriate nutrition extend to long-term neurocognitive development.

International Conference on Human Milk Science & Innovation to Discuss Latest Research

JUNE 9 2022

World-renowned scientists, researchers, and clinicians will convene at the eighth annual International Conference on Human Milk Science and Innovation (ICHMSI) to share the latest research surrounding the scientific and clinical aspects of human milk and its applications. Taking place June 10-11 at the Andaz Vienna Am Belvedere in Vienna, Austria, ICHMSI is the premier forum for thought leaders and medical experts in human milk science. Conference co-chairs, Professor Angelika Berger of the Medical University of Vienna and Professor Michael Zemlin of Saarland University Medical Center, will provide opening and closing remarks. “Since the inception of this conference eight years ago, there has been an incredible evolution in our understanding of the health benefits of human milk,” Professor Berger said. “As clinical applications of human milk evolve, ICHMSI offers the ideal forum for thought leaders worldwide to share the latest research on the clinical potential of human milk, such as the importance of an Exclusive Human Milk Diet (EHMD) on neurodevelopment of critically ill, premature infants, as well as bioactivity and its health benefits for this population.” “It's an exciting time at the intersection of human milk science and neonatology as the benefits of an EHMD in premature infants continue to be demonstrated in study after study," Professor Zemlin said. "By bringing together the greatest minds in the field at ICHMSI, we can share cutting-edge data and engage in important dialogue that will, ultimately, allow us to improve the lives of more infants with human milk nutrition." ICHMSI will include presentations from leading experts in their respective fields:

• Dr Siobhain O'Mahoney, senior lecturer, University College Cork, Ireland: Linking the Microbiome, Gut and Brain in Neonates – the Role of Human Milk
• Professor Charlotte Tscherning, division chief of neonatology and professor in pediatrics, Sidra medicine, Doha, Qatar: Human Milk and Transmission of Viral Disease: A Comprehensive Overview
• Professor Roy Philip, adjunct clinical professor of neonatology, and consultant pediatrician and neonatologist, University Hospital Limerick, Ireland: Influence of Fortification on Human Milk Bioactivity: Sharing an Irish Experience
• Professor Michael Zemlin, clinic director for General Paediatrics and Neonatology, Saarland University Medical Center, Homburg, Germany: Probiotics in ELGANs – Results from a German Multi-Center Trial
• Dr Stephan Seeliger, professor of neonatology, Universitätsmedizin Göttingen, Celle, Germany: Nutrition of Infants With Very Low Birth Weight Using Human and Bovine Based Milk Fortifier – Benefits and Costs
• Professor Rangasamy Ramanathan, chief, Division of Neonatology, Keck School of Medicine of the University of Southern California, USA: Bronchopulmonary Dysplasia: Human Milk May Be the Missing Link
• Professor Maria Lorella Giannì, associate professor of pediatrics, University of Milan, Italy: Human Milk Feeding and Preterm Infants' Growth and Body Composition – Should We Rethink Our Approach?
• Dr Alecia-Jane Twigger, postdoctoral research associate at University of Cambridge, UK: Transcriptional Changes in the Mammary Gland During Lactation
• Professor Christoph Fusch, chair and chief, University Children's Hospital, Paracelsus Medical University and Nuernberg General Hospital, Germany: Feeding the Most Vulnerable – First Look at a Series of <750g Neonates
• Dr Heidi Karpen, neonatologist, Children's Healthcare of Atlanta, and associate professor of pediatrics at Emory University School of Medicine, USA: Impact of an Exclusive Human Milk Diet in Neonates With Congenital Gastrointestinal Disorders – Initial Clinical Results
• Professor Ursula Kiechl-Kohlendorfer, managing director of the Department of Pediatrics and Adolescent Medicine, Medizinische Universität Innsbruck, Austria: Prematurity and Vascular Aging
• Dr Johanna Kostenzer, head of scientific affairs for the European Foundation for the Care of Newborn Infants (EFCNI): Human Milk Regulation in the EU – Implementing Cross-Border Safety and Quality Standards
• Professor Umberto Simeoni, professor and head of pediatrics, CHUV University Hospital, Lausanne, Switzerland: The Role of Nutrition in Defining Long-Term Health Outcomes
• Professor Ann Hellström, professor and chief physician, University of Gothenburg, Sweden: Impact of Enteral Lipid Supplementation and Severe ROP: Results from an RCT
• Dr Christoph Binder, head of Nutritional Medicine (Growth and Body Composition) and deputy head of the neonatal intensive care unit, Medical University of Vienna, Austria: The Impact of an Exclusive Human Milk Diet on Growth, Body Composition and Neurodevelopment – the Vienna Experience
• Professor Boris W Kramer, professor and chair of the faculty of Health, Medicine, and Life Sciences, Maastricht University, the Netherlands: Do Human Milk Fortifiers Improve Neurodevelopmental Outcomes of ELGANs – Results of a Meta-Analysis

This year’s conference will also include a presentation by Dr Alecia-Jane Twigger, PhD, the fourth recipient of the Ruth A Lawrence Investigator Award for Research in Human Milk Science. The annual award recognizes a medical fellow or postdoctoral scholar for their original research in the science of human milk. Dr Twigger was selected based on her study titled "Transcriptional Changes in the Mammary Gland During Lactation Revealed by Single Cell Sequencing of Cells From Human Milk," which found over 110,000 viable or living cells from human milk and breast tissue, which may offer clues to the interplay between pregnancy, lactation, and breast cancer.

New Tool May Identify Pregnant Women With Eating Disorders

MAY 31 2022

A new screening tool may help clinicians identify pregnant women with eating disorders. The 12-question instrument is intended to be a quick way to help clinicians identify women who may may need to be referred to a mental health expert for further evaluation, according to the researchers, who reported on the instrument in a study published in Archives of Women's Mental Health. "It would be most appropriate for clinical encounters so that women can get screened and referred," said Elizabeth Claydon, MD, assistant professor in the Department of Social and Behavioral Sciences at West Virginia University's School of Public Health, in Morgantown, who led the study. "If you miss it, they may carry on their eating disorder throughout their pregnancy." Pregnant women who have an eating disorder are at increased risk for gestational diabetes, premature birth, labor complications, difficulties nursing, and postpartum depression, according to the National Eating Disorders Association. Their babies are at increased risk for premature birth, low birth weight, and poor development. However, clinicians have not had an accurate way of screening pregnant women who may have an eating disorder. The American College of Obstetricians and Gynecologists offered its first clinical guidelines for managing anorexia in pregnancy in April 2022. The group's recommendations include regular monitoring of cardiac and liver function, blood pressure, and heart rate, as well as tests to monitor iron, sodium, potassium, bone density, and blood sugar levels. Anorexia, bulimia, binge eating, and subthreshold disorders — also known as other specified feeding or eating disorder — are among the most common eating disorders among pregnant women. There are no recent data on the incidence or prevalence of eating disorders among pregnant women, according to Lauren Smolar, vice president of mission and education at the National Eating Disorders Association. "It's hard to capture the number of pregnant women affected, since it so often goes undetected," Smolar said. Existing screening tools for eating disorders ask patients whether they're currently pregnant; a questionnaire specifically tailored to pregnant women may help to better gather data on the prevalence within this group, Smolar said. For the new study, Claydon and her colleagues tested the questionnaire among more than 400 mostly White women aged 25–34 years. They found that it could reliably identify women who may have an eating disorder. The questionnaire was validated for women to take during any trimester, according to the findings. A score of 39 or above would serve as an indicator for follow-up. Women who score at least 39 were up to 16 times more likely to receive a diagnosis of an eating disorder compared to women who scored less, the researchers found.

Births Rise for First Time Since 2014

MAY 31 2022

More than 3 million live births occurred in the United States in 2021, the largest increase in the nation's birth rate since 2014, according to the US Centers for Disease Control and Prevention (CDC). Provisional data showed a 1% uptick in births, to 3.66 million, after 6 years of dropping by approximately 2% per year. The gains were concentrated among birthing people ages 25 and older. Teenage births, on the other hand, are at their lowest level since the 1990s, according to the CDC. The agency reported a record 6% decrease in births for teenagers aged 15 to 19 years between 2020 and 2021. Women ages 20 to 25 years also had a record decrease in births of 4% during that period. Brady E. Hamilton, PhD, of the CDC's National Center for Health Statistics, and the lead author of the new report, said the rise in births points to childbearing that was postponed during the pandemic. Data from 2021 showed a 4% drop in the nation's birth rate between 2019 and 2020. "The option to forgo birth is not always viable for older women, but you saw a lot of that during the pandemic," Hamilton said. "Events happened related to job security and the economy that caused people to wait to have a child." Hamilton said more data are needed to determine the full impact of increased overall birth rates on individuals. The final report, which will be released in July, will delve deeper into the influence increased birth rates had on demographics and preterm births, which Hamilton and his team found have increased by 4%.

Food Allergy Risk Not Greater in C-Section Infants

MAY 31 2022

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found. Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery. “The infant immune system undergoes rapid development during the neonatal period,” Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said. In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6. Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally. Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30). Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively. Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Warning Against Increased Lingual Frenotomy in Infants

MAY 31 2022

The French Academy of Medicine published an official statement calling for "more cautiousness for lingual frenotomy in newborns and infants." In January, several academic societies had already expressed concern about the abnormal increase, in France and worldwide, in lingual frenulum surgeries in children following their discharge from maternity clinics. André Chays, MD, member of the French National Academy of Medicine, and Michel Le Gall, MD, member of the French Federation of Orthodontics, have shed light on the practice "A lingual frenulum section (frenotomy) or excision (frenectomy) in newborns or infants involves surgically cutting (with scissors or a laser) a short and/or thick lingual frenulum to restore range of motion of the mobile tongue, in particular its protraction. Until recently, this rare surgical procedure has been indicated for ankyloglossia with a significant effect on function," the Academy of Medicine explained in an official statement published on April 26. Ankyloglossia limits the tongue's range of motion due to a "restrictive" very anterior and/or thick lingual frenulum. It is a congenital anomaly. "This is not a new procedure. It is old and well-known," said Chays, an ear, nose, and throat specialist and member of the French National Academy of Medicine. But what concerns the academy is "the dramatic increase, in France and worldwide, in lingual frenotomy, a procedure which, if performed very soon after discharge from the maternity clinic, supposedly then permits breastfeeding that is both effective for the newborn and infant and painless for the mother." Thus, in Australia, it found an increase of more than 420% in this procedure over a decade. "The increase has not been quantified in France,” said Chays. In January 2021, several academic medical, surgical, and paramedical societies, such as the French Society of Oral Surgery, the French Association for Pediatric Otolaryngology, the French Society of Pediatric Dentistry, and the French Pediatric Society, were already troubled by the abnormal increase, in France and worldwide, in lingual frenulum surgeries in children after their discharge from maternity clinics. Thus, the academic societies pointed out that "lingual frenotomy has always been a standard, albeit quite rare, practice in the maternity clinic. They are performed to address sucking problems following a clinical evaluation and a lack of success in breastfeeding assistance measures. Their unjustified recent increase in the months following birth warrants alerting parents, early childhood experts, and institutional specialists."

The Tiniest Babies: Survival Rates on the Rise

MAY 16 2022

Growing numbers of extremely premature infants are getting lifesaving treatment and surviving. A pivotal study in the Journal of the American Medical Association this year, which looked at nearly 11,000 such births in a neonatal research network that is part of the National Institutes of Health, found that 30% of babies born at 22 weeks, 56% born at 23 weeks and 71% born at 24 weeks lived at least until they were healthy enough to be sent home if doctors tried to save them. Those gains happened gradually and quietly as the notion of viability got a lot more attention in the abortion arena. Viability is mentioned 36 times in the initial draft of the leaked majority opinion by the U.S. Supreme Court in a Mississippi case that would strike down Roe v. Wade. The decades-old abortion ruling says the Constitution protects a woman's right to an abortion before viability, a standard Mississippi argues is arbitrary. But viability has nothing to do with the vast majority of abortions; more than 99% of abortions occur at or before 21 weeks, according to federal statistics. So although viability is central to abortion law, the crux of the argument around the procedure comes down to disagreement about whether and in which cases someone should have the choice to terminate a pregnancy. Meanwhile, viability is a growing real concern for those who care for premature babies as science keeps moving the line lower and lower.

Journal Retracts Cesarean Delivery Paper With 'Impossible’ Data

MAY 16 2022

An ob-gyn journal has retracted a clinically influential 2016 paper on the use of steroids in women undergoing cesarean delivery, citing questions about the data. The article, “Antenatal corticosteroid administration before elective caesarean section at term to prevent neonatal respiratory morbidity: a randomized controlled trial,” appeared in the European Journal of Obstetrics & Gynecology and Reproductive Biology (EJOG), and was written by a group at Cairo University in Egypt led by Adel Nada. The study purported to involve nearly 1,300 women – making it the largest analysis of women receiving steroids for the indication in the trial. But Ben Mol, an ob-gyn researcher and data sleuth at Monash Medical Centre in Australia, noted that the paper – which has been cited 32 times, per Clarivate Analytics’ Web of Science – was based on a thesis by the second author, M.M. Shafeek. Mol and his colleagues questioned the data – and those from two other currently unretracted papers – in an article they submitted to the EJOG in January 2021, titled “Effectiveness of antenatal corticosteroids at term: Can we trust the data that ‘inform’ us?” Short answer: No. Mol noted that new data show that children exposed to steroids via the mother in the antenatal period appear to be at risk of brain damage.

Maternal Autoimmune Diseases Up Risk of Mental Illness in Children

MAY 16 2022

Mental disorders were significantly more likely in children whose mothers had one of five common autoimmune diseases, a new study found. Previous research has linked both maternal and paternal autoimmune diseases and specific mental disorders, such as attention-deficit/hyperactivity disorder (ADHD), but most of these studies focused on specific conditions in relatively small populations. The new study included data on more than 2 million births, making it one of the largest efforts to date to examine the association, according to the researchers, whose findings were published in JAMA Network Open. Previous evidence of the possible association between certain maternal autoimmune diseases and mental disorders in offspring has been "scattered and limited," which "hampered an overall understanding" of the link, Fei Li, MD, the corresponding author of the study, said. Li, of Shanghai Jiao Tong University School of Medicine, in China, and her colleagues reviewed data from a Danish registry cohort of singleton births with up to 38 years of follow-up. They explored associations between a range of maternal autoimmune diseases diagnosed before childbirth and the risks of mental disorders in children in early childhood through young adulthood. The study population included 2,254,234 births and 38,916,359 person-years. Data on mental health were collected from the Psychiatric Central Research Register and the country's National Patient Register. The median age of the children at the time of assessment was 16.7 years; approximately half were male. A total of 50,863 children (2.26%) were born to mothers who had been diagnosed with autoimmune diseases before childbirth. During the follow-up period, 5460 children of mothers with autoimmune diseases and 303,092 children of mothers without autoimmune diseases were diagnosed with a mental disorder (10.73% vs 13.76%), according to the researchers. The risk of being diagnosed with a mental disorder was significantly higher among children of mothers with any autoimmune disease (hazard ratio [HR], 1.16), with an incidence of 9.38 vs 7.91 per 1000 person-years, the researchers report. The increased risk persisted when the results were classified by organ system, including connective tissue (HR, 1.11), endocrine (HR, 1.19), gastrointestinal (HR, 1.11), blood (HR, 1.10), nervous (HR, 1.17), and skin (HR, 1.19). The five autoimmune diseases in mothers that were most commonly associated mental health disorders in children were type 1 diabetes, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and psoriasis vulgaris. The greatest risk for children of mothers with any autoimmune disease was observed for organic conditions such as delirium (HR, 1.54), followed by obsessive-compulsive disorder (HR, 1.42), schizophrenia (HR, 1.54), and mood problems (HR, 1.12). Children of mothers with any autoimmune disorder also had a significantly increased risk of autism (HR, 1.21), intellectual disability (HR, 1.19), and ADHD (HR, 1.19).

Genomic Testing Services Expanded with Ultrarapid Whole Genome Sequencing

MAY 16 2022

PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced the availability of ultrarapid whole genome sequencing (urWGS) through PerkinElmer Genomics. This addition to the Company’s portfolio of whole genome sequencing (WGS) offerings provides physicians with comprehensive, meaningful results in five days to help inform clinical management and improve outcomes for critically ill patients in neonatal and pediatric intensive care units (NICUs and PICUs). With many genetic diseases being chronic and progressive in nature, reducing the time to reaching an accurate diagnosis can eliminate unnecessary procedures, initiate treatment and improve clinical outcomes. The PerkinElmer Genomics urWGS offering uses a dried blood spot sample to provide phenotype-driven analysis with a mean coverage of 40x of a patient’s genome. Studies suggest that up to 15 percent of disease-causing genetic variants may be found in the non-coding regions of the genome, which WGS helps identify. In addition to an analysis of the mitochondrial genome, CNV detection – which identifies deletions, duplications, and other gene- and chromosomal-level events, SMA and a repeat disorders screen – the PerkinElmer urWGS offering includes a StepOne Comprehensive Biochemical Profile. The StepOne offering screens for more than 70 inherited conditions and disorders, including the Recommended Universal Newborn Screening Panel (RUSP) and many others that may not be found in state-mandated programs. “Increasingly, whole genome sequencing is proving its value as a first-tier clinical test for many patients, especially in a NICU and PICU where timely clinical decisions are critical for timely intervention,” said Madhuri Hegde, PhD, FACMG, SVP and chief scientific officer, Global Lab Services, PerkinElmer Inc. “By making services such as this urWGS combined with StepOne available to more hospital systems and physicians, our hope is that we may help shorten the diagnostic odyssey for more newborns and their families. With PerkinElmer’s global leadership in newborn screening using dried blood spot card technology, we will continue to enhance urWGS with additional assays.” As a result of informing and initiating changes in clinical management, rapid WGS tests have been shown to reduce healthcare costs for patients in NICUs and PICUs. Additional benefits of these testing services include the elimination of unnecessary tests and procedures, and reduced length of hospital stays. PerkinElmer Genomics is among the first commercial clinical laboratories to receive approval from the State of New York for its next generation sequencing-based method for WGS using saliva, whole blood, and dried blood spot specimens. In December 2021, the Company also launched a prenatal WGS test offering, further expanding its capabilities as a leader in this space.

Sentynl Therapeutics Announces Launch of Patient Access Program

MAY 4 2022

Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases, owned by Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), today announced the continued availability of NULIBRY (fosdenopterin) for Injection and the launch of Sentynl Cares. NULIBRY is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening pediatric genetic disorder. Sentynl Cares provides a comprehensive set of support programs dedicated to helping children with MoCD Type A in the United States gain access to NULIBRY. Recognizing that most patients with MoCD Type A experience delayed or missed diagnoses that may affect patient outcomes, Sentynl plans to advance initiatives aimed at providing an earlier diagnosis and treatment of the disease. These initiatives include: Supporting the development of a novel newborn screening test, including facilitating the collection of whole blood samples from patients with MoCD Type A disease for assay development and validation, with the aim of universal screening for all babies in the first days of life. Also, advocating for the inclusion of the MOCS1 gene to the commercially available genetic test panels that will aid in the diagnosis of MoCD Type A patients. Plus, launching Sentynl Cares a comprehensive set of support programs dedicated to helping children get access to our therapies. Sentynl Cares also provides tools and resources to help facilitate the access process. Sentynl's Chief Executive Officer, Matthew Heck, said, "Early diagnosis and therapeutic intervention is critical to MoCD Type A disease patients and their caregivers.  Our company is proud to advance initiatives that are aimed at earlier diagnosis and treatment of rare diseases like MoCD Type A." Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., said, "These initiatives align with our core purpose to empower patients suffering from rare disease with the freedom to live healthier and fulfilled lives. Zydus is proud that NULIBRY (fosdenopterin) is now among its portfolio of rare disease treatments designed improve outcomes for patients and their caregivers." MoCD Type A is an autosomal recessive, inborn error of metabolism caused by mutations in the molybdenum cofactor synthesis 1 gene and characterized by a deficiency in molybdenum cofactor production, leading to a lack of molybdenum-dependent enzyme activity. The lack of activity leads to decreased sulfite oxidase activity with buildup of sulfite and secondary metabolites (such as S-sulfocysteine) in the brain, which causes irreversible neurological damage. MoCD Type A is an ultra-rare disease. The incidence and prevalence of MoCD Type A in the United States are not known, but the estimated incidence is 1 per 100,000 live births. Based on these estimates, MoCD Type A is likely to be underdiagnosed, with an estimated 22 to 26 missed diagnoses per year in the United States and European Union. The most common presenting symptoms of MoCD Type A are seizures, feeding difficulties and encephalopathy. Patients with MoCD Type A who survive beyond infancy typically suffer from progressive brain damage, which presents in characteristic patterns on magnetic resonance imaging (MRI). This damage leads to severe psychomotor impairment and an inability to make coordinated movements or communicate with their environment.

Second-Trimester Blood Test Predicts Preterm Birth

APR 29 2022

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial. The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues. “Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.” Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added. The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB. Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded. The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87). Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr Camunas-Soler and colleagues suggested.

Furosemide Seen as Safe for Preventing Newborn Lung Disease

APR 29 2022

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study. Furosemide (Lasix) — which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble — is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting. BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood. "There are so few drugs that have been tested for newborns and there are very little data to help neonatologists decide if certain medications are safe and effective," said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, North Carolina. "We found there was no greater risk of safety events for newborns given furosemide." Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks' gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo. Although babies given furosemide had more problems with electrolytes — an expected outcome from the use of diuretic medications — the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Greenberg said. "The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen," she said. "The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes." The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Greenberg said the study was underpowered to detect such an effect.

Nafcillin Therapy a Safe Alternative to Vancomycin for Infants With Late-Onset Sepsis

APR 29 2022

A change in treatment guidance to reduce the use of vancomycin in the neonatal intensive care unit (NICU) for late-onset sepsis was safe, sustained, and resulted in similar mortality outcomes, a study of three Ohio NICUs found. In the retrospective review of over 350 infants who received an empirical antibiotic course for possible late-onset sepsis, use of vancomycin fell from 84% in 2013-2014 to 25% in 2017-2019 following vancomycin reduction guidelines for those without a history of methicillin-resistant Staphylococcus aureus (MRSA). And the proportion of infants receiving nafcillin jumped from 16% to 75% between the two study periods, reported Jacqueline Magers, PharmD, of Nationwide Children’s Hospital in Columbus.

Award Handed Out For Research Into Human Milk Science

APR 27 2022

The International Conference on Human Milk Science and Innovation (ICHMSI) announced that Dr Alecia-Jane Twigger is the fourth recipient of the Ruth A. Lawrence Investigator Award for Research in Human Milk Science. Established by ICHSMI in 2016, the Ruth A. Lawrence Investigator Award goes to outstanding contributors advancing human milk science and breastfeeding medicine through original research. It is named in honor of Dr. Ruth A. Lawrence, MD, a pioneer in the field of lactation and breast milk. Twigger's research, published in Nature Communications and titled "Transcriptional Changes in the Mammary Gland During Lactation Revealed by Single Cell Sequencing of Cells From Human Milk," was selected by an independent panel of expert judges. Twigger's research found over 110,000 viable or living cells from human milk and breast tissue, which may offer clues to the interplay between pregnancy, lactation, and breast cancer. "As we continue to advance the scientific and clinical innovations of human milk, we rely on research such as Alecia-Jane Twigger's and are looking forward to how her findings will further our goal of raising awareness on the scientific potential and benefits of human milk," Lawrence said. Twigger's findings may have significant implications for the industry, with her study demonstrating the power demographic factors such as age and parity have on the composition of the adult mammary gland and how this might influence long-term breast cancer risk. "I have always been fascinated by cells in milk and think they hold the key to helping us understand human milk production," Twigger said. "This work has taken over four years to complete, but it was well worth it. I hope the findings will advance our understanding of how to optimize milk products to support long-term maternal and infant health outcomes." Twigger will accept the award and present her research at the eighth-annual International Conference on Human Milk Science and Innovation in Vienna on June 10-11, 2022. She will also receive a $10,000 award and travel expenses to attend the event. Twigger is currently a research associate in the Department of Pharmacology at the University of Cambridge, Wellcome-MRC Cambridge Stem Cell Institute. She received her bachelor's degree from The University of Western Australia and received her Ph.D. in cell biology, biochemistry, and human nutrition from the School of Chemistry and Biochemistry at The University of Western Australia. Throughout her career, Twigger has been awarded several prestigious recognitions, including the Federation of American Societies for Experimental Biology (FASEB) Junior Investigator Award, the Seed Funding grant of the UHU collaborative network, and a postdoctoral fellowship at Helmholtz Zentrum München, to name a few. The current research that has earned the Ruth A. Lawrence Award has also been covered in several prominent media outlets, including Medical News Today, SciTechDaily, and ScienceDaily.

Neonatal Hypoglycemia Doesn't Affect Childhood Academics

APR 17 2022

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children. Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues. In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL. The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health. Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95). No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behaviour manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted. However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%). The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said. The study findings were limited by several factors including the lack of data on several measures of cognition, notably processing speed, and a lack of adjustment for intelligence quotient at age 4.5 years, the lack of data on any treatment for developmental impairment, and the inclusion of a population with well-managed hypoglycemia, the researchers said. However, the results were strengthened by having a sample size large enough to detect associations, the prospective design, and the accurate measure of neonatal glycemic exposure, they said. Although the results suggest that at-risk children reach similar endpoints by the end of primary school, “efforts to prevent and optimize adverse pregnancy conditions remain important, and developmental surveillance after birth should be considered for at-risk infants,” they concluded.

Preterm C-Sections, Induced Deliveries Dropped During COVID-19 Pandemic

APR 17 2022

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found. Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics. The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question. The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted. That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said. Dr Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.” Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March. So far, Dr Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention. To better understand those implications, Dr Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year. If there was no change in fetal deaths at the same time as the drop in preterm births, Dr Dench said, that could point to physician interventions that may not have been necessary.

No Adverse Effect of mRNA Shot for Pregnant Women, Newborns

APR 17 2022

According to the European Medicines Agency (EMA)’s COVID-19 task force (ETF), a growing body of evidence suggests that messenger RNA (mRNA) COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies. The ETF undertook a detailed review of several studies involving around 65,000 pregnancies at different stages and did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination. Despite some limitations in the data, the EMA stated the results appear consistent across studies looking at these outcomes. The studies also highlighted that COVID-19 vaccines are as effective at reducing the risk of hospitalisation and deaths in pregnant people as they are in non-pregnant people. In addition, the most common side effects in pregnant people are the same as those in the overall vaccinated population. These symptoms, including pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills, are usually mild or moderate and improve within a few days of vaccination.

Company Awarded Patent on International Women’s Day

APR 7 2022

Ultrasound AI, Inc., an artificial intelligence company dedicated to improving women’s health, announced that they were awarded their first patent on International Women’s Day for the software powering their groundbreaking predictive diagnostic medical technology, Preterm AI (PAI). PAI combines the power of ultrasound with artificial intelligence to predict preterm birth. The U.S. patent application states PAI’s software has been applied to real-world data obtained from a clinical context and has been shown to consistently produce a positive predictive value (the AI predicts a preterm birth, and the mother then delivers preterm) above 90% and a negative predictive value (the AI predicts a normal birth, and then the mother delivers the baby at full term) above 90%. "This technology has the potential to revolutionize obstetric care as well as accelerate research to develop new interventions to prevent both premature births and miscarriages," said Dr Garrett K. Lam, FACOG, Chief Medical Officer at Ultrasound AI. Preterm birth is when a baby is born before 37 weeks of pregnancy. In 2020, preterm birth affected one in 10 infants born in the United States. Preterm birth complications are the leading cause of death among children under five years of age, responsible for approximately one million deaths annually. Premature births often result in emotional trauma for families, prolonged stays in specialty care nurseries, and profound health consequences for preterm infants. Many women who deliver prematurely have no known risk factors or early symptoms of complications. “Doctors assume 280 days until birth, and they may be able to label someone as ‘at risk,’ but that isn’t necessarily accurate. The ability to accurately predict if a baby will be born early and how early are non-existent using ultrasound imaging. The current blood tests are limited in use and accuracy, and can be expensive,” explains Robert Bunn, President and Founder of Ultrasound AI. Bunn is the pioneering expertise behind this discovery. After he and his wife experienced nine miscarriages and the happy arrival of four daughters over time, he knew he wanted to “make a huge dent in every serious affliction that only impacts women.” He used AI to analyze the data from 400,000+ de-identified ultrasound images. The AI learned patterns from those images and was eventually able to recognize patterns in images and associate them with birth outcomes. “There’s a lot of noise in the images in ultrasound, so humans have difficulty seeing the image and understanding it. Our AI software is trained to do what we can’t and see things that we can’t see. Most people wouldn’t even consider this possible,” shared Bunn. Now, after four years of cutting-edge research and development, this revolutionary new AI software shows the promise to change the lives of countless families around the world. PAI has the power to give providers and patients timely, accurate information to make better-informed decisions and improve the wellbeing of babies and mothers.

New Faces on Company’s Board

APR 5 2022

Nonin Medical announced the appointment of five new members to the company’s board of directors. The new directors bring a diverse and unique set of experiences, along with a passion for growth and innovation in the medical device and healthcare sectors. Together, they will provide Nonin with strategic guidance and support the company’s continued growth. The new board members are:

• Waqaas Al-Siddiq, Founder and CEO of Biotricity
• Larry Betterley, President and CEO of Lexington Advisors, LLC
• Angela Dillow, Strategic Consultant and Board Director at Regions Hospital
• Laura Gillund, Corporate Board Director and Global Human Resources Executive
• Robert Rajalingam, President, U.S. Medical Products & Distribution, Cardinal Health

“We have assembled a team of world-class board members with successful track records in the industry who will provide valuable business insights as we accelerate our growth trajectory and serve customers across the globe. Looking to the future of Nonin, we are confident the new board members are uniquely qualified to support the next growth phase of the company,” stated Phil Isaacson, Executive Chairman, Chief Technology Officer and Founder, Nonin Medical. With healthcare technology playing a major role in the management of the global pandemic, the Nonin leadership team recognized the need for a new board of directors to help the company address rapidly changing market needs and meet the demands of providers, payors, and other audiences using health-driven digital and data solutions. Phil Isaacson will continue in his board role. The biographies of the new board are available at Nonin.com.

BridgeBio Pharma and Sentynl Therapeutics Announce Asset Purchase Agreement

APR 4 2022

BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, and Sentynl Therapeutics, Inc., a US-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases owned by Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), announced the execution of an asset purchase agreement (the Agreement) for the sale of BridgeBio’s NULIBRY (Fosdenopterin) for Injection. NULIBRY is approved by the US Food and Drug Administration (FDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening pediatric genetic disorder. The closing of the asset purchase is subject to customary closing conditions. “Sentynl’s focus on meaningful treatments for serious rare diseases is further enhanced by the acquisition of Fosdenopterin. We will leverage our existing platform of ultra-rare pediatric disease initiatives to facilitate early diagnosis and treatment by enhancing awareness, newborn screening, genetic testing and patient support across multiple products and rare diseases. By partnering with BridgeBio, we hope to reach even more patients born with MoCD Type A as quickly as possible with the hope of reducing the risk of mortality and progression of this devastating disease,” said Matt Heck, CEO of Sentynl. Under the Agreement, Sentynl will acquire global rights to NULIBRY and will be responsible for the ongoing development and commercialization of NULIBRY in the United States and developing, manufacturing and commercializing Fosdenopterin globally. BridgeBio will share development responsibilities for Fosdenopterin through approval of the marketing authorization application already under accelerated assessment with the European Medicines Agency and through approval of its regulatory submission with the Israeli Ministry of Health. Sentynl will provide cash payments upon the achievement of certain regulatory milestones. BridgeBio will be eligible to receive commercial milestone payments as well as tiered royalties on adjusted net sales of NULIBRY. “Sentynl is an ideal partner given its expertise in the rare pediatric neurodevelopment space and its relationships with physicians who diagnose and treat children with MoCD Type A,” said Neil Kumar, Ph.D., founder and CEO of BridgeBio. “Focused execution means reducing the scope of our internal activity. We will continue to advance high-quality programs in our pipeline while expanding our reach to patients in need of options.”

No Adverse Effect of mRNA Shot for Pregnant Women, Newborns

MAR 31 2022

According to the European Medicines Agency (EMA)’s COVID-19 task force (ETF), a growing body of evidence suggests that messenger RNA (mRNA) COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies. The ETF undertook a detailed review of several studies involving around 65,000 pregnancies at different stages and did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination. Despite some limitations in the data, the EMA stated the results appear consistent across studies looking at these outcomes. The studies also highlighted that COVID-19 vaccines are as effective at reducing the risk of hospitalisation and deaths in pregnant people as they are in non-pregnant people. In addition, the most common side effects in pregnant people are the same as those in the overall vaccinated population. These symptoms, including pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills, are usually mild or moderate and improve within a few days of vaccination.

Hydrocortisone Fails to Prevent Bronchopulmonary Dysplasia in Preemies

MAR 31 2022

Systemic hydrocortisone (HC) does not reduce the risk for bronchopulmonary dysplasia (BPD) or for a composite endpoint of BPD or death in very preterm infants receiving mechanical ventilation, a randomized trial shows. However, a planned secondary analysis suggests that HC may reduce the risk for death when analyzed as an endpoint on its own. "Our study shows that HC does not reduce BPD. Our finding that it does reduce death is somewhat surprising, although trials on prophylactic HC use indicated that this might be a benefit from HC," senior author Anton H. van Kaam, MD, PhD, from the department of neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, the Netherlands, said. Wes Onland, MD, PhD, from the department of neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, the Netherlands, and colleagues published their findings online January 29 in JAMA for the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) Study Group. Dexamethasone is effective at reducing the risk for death or BPD in this patient population. "However, this benefit may be outweighed by an increased risk of neurodevelopmental impairment. As a result, clinicians started using dexamethasone less frequently, in lower doses, and at later postnatal ages. Furthermore, international guidelines recommended investigating whether hydrocortisone would be an effective and safe alternative to dexamethasone," the authors write. The researchers conducted a double-blind, placebo-controlled randomized trial to determine whether systemic hydrocortisone treatment started between 7 and 14 days after birth decreased the incidence of death or BPD at 36 weeks' postmenstrual age in ventilator-dependent very preterm infants. The study included 372 infants (mean gestational age, 26 weeks; 55% male) in 19 neonatal intensive care units with a gestational age of less than 30 weeks and/or birth weight below 1250 g. The infants were randomly assigned to receive systemic hydrocortisone (cumulative dose, 72.5mg/kg; n = 182) or placebo (n = 190) for 22 days. One infant treated with hydrocortisone was withdrawn from the study by the parents.

ART Associated With Less Risk of Preterm Birth in Large US Study

MAR 31 2022

Over the past decade, data have suggested that antiretroviral therapy (ART) may be associated with an increased risk for adverse pregnancy outcomes, namely, preterm birth (PTB). But a combination of methodologic challenges, demographic gaps, and spotty clinical data has left the question unresolved, especially for pregnant women with HIV who reside in developed countries. "Given that a lot of the emerging data has come out of resource-limited settings where patient and clinical characteristics are different from developed world settings like the United States, we felt that this was an important question to address," Kartik Venkatesh, MD, PhD, a high-risk obstetrician and perinatal epidemiologist at the Ohio State Wexner Medical Center, said. In a prospective cohort study of US women with or at risk for HIV, Venkatesh and his colleagues found that ART exposure (including highly active antiretroviral therapy [HAART]) was associated with as much as an 80% decline in the likelihood of PTB (defined as birth <34 weeks). The study was published in the upcoming special April issue of HIV Medicine, devoted to women and HIV. Venkatesh and his team analyzed self-reported birth data of women with singleton live-born pregnancies enrolled in the ongoing, multicenter, prospective observational Women's Interagency HIV Study (WIHS) from October 1, 1995, to March 31, 2019. "We first looked at women with HIV vs without HIV, [who were] matched on many clinical and sociodemographic characteristics and at similarly high risk of some of these obstetrical outcomes like PTB," explained Venkatesh. "We then looked at the relative impact of antiretroviral therapy amongst women living with HIV compared to no antiretroviral therapy." ART regimens were classified as none, monotherapy, dual therapy, or HAART. (HAART was defined as more than three antiretrovirals, including at least one protease inhibitor [PI], nonnucleoside reverse transcriptase inhibitor, integrase inhibitor, or entry inhibitor.) In this cohort, for 63.5% of women receiving ART, therapy was initiated before pregnancy (mean duration of HAART, 6 years), and most were virally suppressed. Among the 4944 women assessed in the WIHS trial, 74% (3,646) had HIV. In total, 383 women had 488 singleton deliveries, including 218 women with HIV (272 deliveries) and 165 without HIV (216 deliveries). Sociodemographics in both cohorts were well matched. For most participants, the mean age was 40–41 years at delivery, most were non-Hispanic Black persons, and the mean pregnancy body mass index was ≥29 kg/m2. Of the women with HIV, 33% had chronic hypertension; of those without HIV, 42.1% had chronic hypertension; 4.7% and 5.0%, respectively, had pregestational diabetes.

Neurodevelopmental Disorders Prevalent With Extremely Preterm Birth

MAR 31 2022

A large registry-based cohort study in Sweden has revealed that 75% of children born before 24 weeks of gestation had neurodevelopmental disorders, including intellectual disabilities and autism, and required habilitative services. In addition, somatic disorders such as asthma and failure to thrive/short stature were diagnosed in 88% of the cohort. The findings, published in Acta Paediatrica, emphasize the need for further study of this population, especially as survival rates continue to increase. “The primary aim of this large, retrospective, national study was to report clinical diagnoses registered after children born before 24 weeks were discharged from neonatal care,” explained lead author Eva Morsing, MD, PhD, of Lund (Sweden) University, and colleagues. Data on diagnoses of neurodevelopmental disorders and selected somatic diagnoses were obtained from national Swedish registries. Study participants’ individual medical files were also examined by the researchers. The study cohort comprised 383 infants born at a median of 23.3 weeks of gestation (range, 21.9-23.9 weeks). The median birthweight of participants was 565 grams (range, 340-874 grams), with a median birthweight standard deviation (SD) of −0.40 (range, −3.63–3.17). The majority (75%) of infants had a neurodevelopmental disorder, including speech disorders (52%), intellectual disabilities (40%), attention-deficit/hyperactivity disorder (30%), autism spectrum disorder (24%), visual impairment (22%), cerebral palsy (17%), epilepsy (10%), and hearing impairment (5%). With respect to gender, a greater number of boys than girls born at 23 weeks had intellectual disabilities (45% vs. 27%; P < .01) and visual impairment (25% vs. 14%; P < .01). Moreover, 55% of the participants were referred for habilitative services. With respect to somatic diagnoses, failure to thrive/short stature was diagnosed in 39% of the cohort, and it occurred more often in those born at 21 and 22 weeks than in those born at 23 weeks (49% vs. 36%; P < .05). In addition, asthma and childhood bronchopulmonary dysplasia, pulmonary hypertension, and vocal cord paresis were diagnosed in 63%, 12%, and 13% of participants, respectively.

Neonatal Hypoglycemia Doesn't Affect Childhood Academics

MAR 31 2022

Children at risk of neonatal hypoglycemia who were screened and treated if needed showed no difference in educational achievement from controls at age 9-10 years, based on data from 480 children. Previous studies have shown an increased risk of poor executive and visual-motor function in children with neonatal hypoglycemia, but the effect on later childhood academic performance remains unclear, wrote Rajesh Shah, PhD, of the University of Auckland, New Zealand, and colleagues. In a prospective cohort study published in JAMA, the researchers enrolled moderate to late preterm and term infants born at increased risk for hypoglycemia; those with episodes of hypoglycemia were treated to maintain a blood glucose concentration of at least 47 mg/dL. The study population was enrolled between 2006 and 2010 at a regional perinatal center in New Zealand, and their educational achievement was assessed 9-10 years later. The primary outcome of low educational achievement was defined as performing below the normal curriculum level in standardized tests of reading comprehension or math. The researchers also identified 47 secondary outcomes related to executive function, visual-motor function, psychosocial adaptation, and general health. Rates of low educational achievement were not significantly different for children with and without neonatal hypoglycemia (47% vs. 48%, adjusted risk ratio 0.95). No significant differences appeared between the two groups for any secondary outcomes, including reading comprehension, math, behavior manifestations of executive function, fine motor function, autism traits, and overall well-being, the researchers noted. However, children with neonatal hypoglycemia were significantly less likely to be rated as below or well below reading curriculum level by teachers compared to those without neonatal hypoglycemia (24% vs. 31%). The researchers cited a previous study of the same patient cohort at age 4.5 years, which suggested an association between adverse neurodevelopmental outcomes and infant hypoglycemia. However, the reason this association did not persist at age 9-10 years remains unclear, the researchers wrote in their discussion. “Early disturbances in brain development may have diminishing effects over time due to neuroplasticity, that is, reorganization of neural networks, or delayed maturation with mid-childhood catch-up in neurocognitive function,” they said.

Study Shows Benefits of Human Milk-based Fortifiers

MAR 29 2022

An independent, head-to-head study from Neuburg, Germany, shows extremely low birth weight preterm infants fed Prolacta Bioscience 100% human milk-based fortifiers (HMBF) as part of an Exclusive Human Milk Diet (EHMD) had reduced  incidences of life-threatening comorbidities and experienced shorter stays in the neonatal intensive care unit (NICU), compared to those fed cow/bovine milk-based fortifiers (CMBF), offsetting the higher therapeutic costs of HMBF. The study, “Nutrition of Infants with Very Low Birth Weight Using Human and Bovine Based Milk Fortifier: Benefits and Costs,” was published in Neonatal and Pediatric Medicine and is the first head-to-head clinical trial of nutritional fortifiers conducted within Germany’s national health care system. The findings corroborate the results from more than 20 peer-reviewed studies demonstrating the benefits of Prolacta’s 100% human milk-based fortifiers, compared to cow-milk based fortifiers. The study compared whether preterm infants benefited from Prolacta’s human milk-based fortifier supplementation compared to cow/bovine milk-based fortifiers and whether the higher purchase costs were economically viable for hospitals. It found that preterm infants tolerate human milk-based fortifiers significantly better than bovine-based fortifiers, and while the human milk fortifiers entail higher therapeutic costs, they are offset by shorter in-hospital stays and fewer morbidities. The objective of the independent study was twofold: 1) To determine whether extremely low birth weight preterm infants benefit from a HMBF compared to CMBF regarding food tolerance and common comorbidities of prematurity; and 2) To evaluate whether the higher purchase costs associated with HMBFs are economically viable for Germany’s hospital NICUs. The study included 23 preterm infants of < 32 + 0 gestational weeks, born weighing less than 1,000 g (2.2 Ibs), admitted to the NICU at KJF Klinik St. Elisabeth, Neuburg an der Donau, Germany, between January 2019 and December 2020.1 The study allowed parents to choose between HMBF or CMBF supplementation; there were no other differences in the remaining nutrition and care. Based on the total number of events observed in the study, typical morbidities in the HMBF group were significantly less frequent (30%) than in the CMBF group (77%, P = 0.04). Due to the small sample size, individual comorbidities did not reach statistical significance. All comorbidities were higher in the CMBF group. As such, the study concluded the group of infants fed Prolacta’s human milk-based fortifier had significantly fewer preterm neonate morbidities over the entire clinical course compared with preterm infants given the cow milk-based fortifier. Additionally, fecal calprotectin values in the stools of preterm infants – a marker for gastrointestinal tract inflammation – were significantly lower in the HMBF group than the CMBF group at days 35 (P = 0.02) and 42 (P = 0.03), suggesting improved gastrointestinal tolerance and reduced inflammation. Even though the HMBF group was smaller at birth, weight gain was as good as the CMBF group and resulted in fewer comorbidities. The study reported that preterm infants given HMBF were discharged from the hospital a median of 75.5 days versus 80 days in the CMBF group. This resulted in a revenue gain of €5958.20 ($6,758.65 USD) per patient in the HMBF group. Making the same calculation for the CMBF group, this resulted in a per-patient revenue loss of €346.00 ($392.48 USD)‚ respectively. Likely due to the small number of comorbidities throughout the study, the revenue gain in the HMBF group was negated by the cost of the fortifier. Larger centers with higher case numbers may see a distinct economic advantage due to earlier discharge of preterm infants and decreased morbidities. Furthermore, earlier discharge creates additional capacity in NICUs, resulting in a positive impact on cost-effectiveness. “The German study reaffirms, in a head-to-head trial, that not only is early fortification with human milk fortifiers better tolerated by the smallest neonates, but it is also the key to achieving healthy growth and reduced complications among these infants,” said Melinda Elliott, MD, chief medical officer at Prolacta and a practicing neonatologist. “Human milk is a complex, dynamic bioactive fluid with a myriad of compounds that make it the preferred nutrition for extremely low birth weight preterm infants to support their immunity, growth, neurodevelopment, and overall long-term health.  The resulting benefit of Prolacta’s fortifiers, as part of an EHMD, to preterm infant health and the reductions in the cost of care, as demonstrated in this study, are being replicated worldwide by institutions using Prolacta’s feeding protocol in the first days of life.”

Neotech Turns 35

MAR 29 2022

Neotech Products LLC is excited to celebrate its 35th year developing and manufacturing innovative medical devices. Neotech Products is an essential brand in hospitals worldwide. Products include the RAM Cannula, Little Sucker suction tips, NeoShades Phototherapy Eye Shields, NeoBar ET Tube Holder, and more. Neotech made its mark as a neonatal company, but its reach extends beyond the NICU into pediatrics, children’s oncology, home healthcare, and more. They even offer products for adults, like EZCare trach ties and NeoSucker suction tips. “I think I am most proud of the impact we’ve made as a company over the last 35 years,” said Craig McCrary, Neotech President. “Impact to employees, impact to clinicians, and impact to patients and parents. “We’ve done things that have made a positive difference in many lives around the globe.” McCrary, who has been with Neotech for over 30 years, credits company success to: Simple, unique products; clinician-driven products that fill a need, and products made in the USA. “Made in the US has truly set us apart,” McCrary said. “Especially this past year when so many companies have experienced supply chain issues.” Neotech is a proud Certified B Corporation that continues to expand its international presence by developing simple solutions to medical needs. To learn more about Neotech and its products, please visit neotechproducts.com.

Article Looks at Homogenization of Human Milk-based Products

MAR 23 2022

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for premature, critically ill infants, announced the publication of a journal article that summarizes existing evidence on the impact of homogenization on human milk-based nutritional products. The article focuses on changes to the macromolecular structure of the milk fat globule (MFG) and the subsequent impact on digestion and was published in December in the peer-reviewed journal Current Developments in Nutrition. Authored by Sarah M. Reyes, Ph.D., MSc, and colleagues, "The Impact of Homogenization on Donor Human Milk and Human Milk-Based Fortifiers and Implications for Preterm Infant Health" uses published data to create a conceptual framework for the potential implications of homogenized human milk-based nutritional products on preterm infant health and suggests avenues for future research. "Homogenization disrupts the milk fat globule, which may lead to premature digestion of bioactive components, including sphingolipids and long-chain polyunsaturated fatty acids (LCPUFAs), linked to favorable neurological outcomes. The implications of these changes for infant health are unknown," according to Reyes, scientific liaison, human milk and clinical research, at Prolacta. Homogenization is a process that evenly disperses two liquids to create a single uniform mixture. In the dairy industry, homogenization is used to improve cow milk's taste, consistency, and appearance, as well as to extend its shelf life. Dairies homogenize cow milk to disperse fat droplets and prevent the cream from rising to the top. Human milk is a complex, dynamic bioactive fluid with a myriad of compounds that make it the preferred nutrition for infants to support their immunity, growth, neurodevelopment, and overall long-term health. "The well-established clinical benefits of human milk-based nutritional products only apply to currently available non-homogenized products. The safety and efficacy of homogenized human milk-based nutritional products have not been established," Reyes wrote. "Human milk-based nutritional products are not created equally," said Melinda Elliott, chief medical officer for Prolacta, practicing neonatologist, and a study co-author. "As human milk researchers and medical professionals, it is our opinion that the use of industrial processing techniques such as homogenization, with or without high-heat processing, should be avoided for human milk-based nutritional products until their safety and efficacy have been established."

Baby-Friendly' Steps Help Women Meet Prenatal Breastfeeding Goals

MAR 15 2022

A first-ever study of the effect of evidence-based maternity care practices on prenatal breastfeeding intentions in women from low-income U.S. households shows that the use of "baby-friendly steps" during birth hospitalization made it possible for almost half to breastfeed exclusively for 1 month. Analyses of national data from a longitudinal study of 1,080 women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) revealed that 47% were able to meet their prenatal intention to breastfeed without formula or other milk for at least 30 days.

The odds of meeting prenatal breastfeeding intentions more than quadrupled when babies received only breast milk (risk ratio, 4.4; 95% confidence interval, 3.4-5.7), the study showed. Breastfeeding within 1 hour of birth was also associated with greater likelihood of breastfeeding success (RR, 1.3; 95% CI, 1.0-1.6). The study, led by Heather C. Hamner, PhD, MS, MPH, of the National Center for Chronic Disease Prevention and Health Promotion, Atlanta, was reported online in Pediatrics. "This study confirms the relationship between experiencing maternity care practices supportive of breastfeeding and meeting one's breastfeeding intentions, and adds evidence specifically among low-income women, who are known to be at higher risk of not breastfeeding," the study authors wrote. Women from low-income households often face additional barriers to meeting their breastfeeding goals, including lack of access to professional lactation services, Hamner said in an interview. "We want physicians to know how important maternity care practices supportive of breastfeeding are to helping all women achieve their breastfeeding goals. Physicians can be champions for implementation of evidence-based maternity care practices in the hospitals and practices in which they work." Hamner emphasized that physicians need to discuss the importance of breastfeeding with patients and their families, brief them on what to expect in the maternity care setting, and ensure women are connected to lactation resources. The American Academy of Pediatrics is working to increase physician capacity to support breastfeeding through the Physician Engagement and Training Focused on Breastfeeding project. For the study, Hamner and colleagues analyzed data from the longitudinal WIC Infant and Toddler Feeding Practices Study-2 (ITFPS-2), which assessed the impact of 6 steps from a 10-step maternity care protocol known as The Ten Steps To Successful Breastfeeding. These steps are part of the worldwide Baby-Friendly Hospital Initiative (BFHI), which has been shown to improve rates of breastfeeding initiation, duration, and exclusivity.

Enzyme Deficiency Linked to Preeclampsia

MAR 15 2022

Both preeclamptic mice and human placentas from women with preeclampsia show a deficiency of S-nitrosoglutathione reductase (GSNOR), suggesting that the deficiency underlies the condition, researchers have found. Notably, in mice, ascorbic acid ameliorated most of the symptoms. “It was surprising that a mutation in a single gene, GSNOR, can cause many of the complications associated with preeclampsia,” Shathiyah Kulandavelu, PhD, of the University of Miami, said. “Preeclampsia is a multisystemic/multifactorial disease, and based on the heterogeneity of the clinical presentation, there may be different subtypes,” she said. “Therefore, identifying women showing dysregulation in nitrosylation and/or altered GSNOR activity levels may be an ideal target subpopulation for treatment with vitamin C or another antioxidant, permitting for a precision medicine approach for future clinical trials.” The disorder is characterized by “an increase in nitrosylated proteins and reactive oxygen species, suggesting a pathophysiologic role for dysregulation in nitrosylation and nitrosative stress,” Dr Kulandavelu and colleagues noted in their study, published in the Journal of the American Heart Association. The team showed that mice lacking S-nitrosoglutathione reductase, a denitrosylase that regulates protein S-nitrosylation, have a preeclampsia phenotype, including hypertension, proteinuria, renal pathology, cardiac concentric hypertrophy, decreased placental vascularization, and fetal growth retardation. In such mice, reactive oxygen species, nitric oxide, and peroxynitrite levels are elevated and, notably, mass spectrometry showed elevated placental S-nitrosylated amino acid residues. Further investigation showed that ascorbate reverses the phenotype, except for fetal weight, and reduces the difference in the S-nitrosoproteome. The team then studied human preeclamptic placentas and found decreased GSNOR activity and increased nitrosative stress, similar to the mouse model. “Deficiency of GSNOR creates dysregulation of placental S-nitrosylation and preeclampsia in mice, which can be rescued by ascorbate. Coupled with similar findings in human placentas, these findings offer ... .insights and therapeutic implications for preeclampsia,” the authors wrote. Dr Kulandavelu said the team’s next research steps will include studying the placentas collected from preeclamptic mothers to identify biomarkers that could inform treatment and better mechanistic understanding of what may be driving the increased mortality and complications in both the mother and newborn. “Furthermore,” she said, “emerging data suggest that preeclamptic mothers and babies born to preeclamptic mothers are predisposed to future cardiovascular and renal disease. Therefore, the next step will be to follow these mothers and newborns later in life to examine whether they show early signs of cardiovascular and renal disease.” Lara Kovell, MD, director of the Pregnancy and Heart Disease Clinic at the University of Massachusetts, Worcester, said in an email, “This is an exciting study that helps to shed light on the pathology of preeclampsia” Regarding specific findings, she noted, “Antioxidant treatment rescued preeclampsia phenotypes in the mouse model. However, prior human studies on antioxidants have not ended up helping to prevent preeclampsia. The authors suggest that is because of multiple preeclamptic phenotypes, with likely more than one potential cause. Eventually, precision medicine should help to determine who would benefit the most from these antioxidant treatments. “Another concern is that in the mouse model, fetal weight did not improve in the GSNOR knockout mice treated with ascorbate,” she said. “So, while the maternal condition improved, the infant outcomes were not uniformly improved.”

Obesity, Diabetes in Women Linked to Their Birth Weight

MAR 15 2022

In a study of just over 4000 middle-aged women in China, researchers found: A U-shaped relationship between low, normal, or high birth weight and risk of adult obesity, with the lowest risk at a birth weight of 3000 g (the midpoint of the normal birth weight range of 2500 g to < 3500 g); risk of type 2 diabetes in normal-weight women was highest in those with a low birth weight and decreased as birth weight increased. Among these middle-aged women, those with a high birth weight had a high obesity rate but a low prevalence of type 2 diabetes, whereas those with a low birth weight had a high obesity rate and a high prevalence of type 2 diabetes. Women with overweight or obesity had a higher prevalence of type 2 diabetes, independent of their birth weight. Women with a lower birth weight and overweight or obesity had the highest prevalence of type 2 diabetes. The results confirmed that overall low birth weight is associated with increased risk of having type 2 diabetes in middle-aged women. The results also showed that overweight or obesity in middle age upped the risk of diabetes, independent of birth weight.

Assisted Reproduction Tied to Increased Risk for Vascular, Pregnancy Complications

FEB 28 2022

Women who conceive with assisted reproductive technology (infertility treatment) may be at increased risk for vascular and pregnancy-related complications, according to new research published today in a special Go Red for Women issue of the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association. Assisted reproductive technology, also known as ART, is the umbrella term for infertility treatments in which eggs or embryos are handled to improve the odds of pregnancy. These treatments may involve administering medication to control timing of ovulation, as well as procedures such as in vitro fertilization (IVF) or intracytoplasmic sperm injection, during which a woman's eggs are surgically retrieved and fertilized in a laboratory before being implanted back into her uterus. According to 2019 statistics from the U.S. Centers for Disease Control and Prevention, the use of assisted reproductive technology has more than doubled during the past decade. More than 2% of infants born in the U.S. every year are conceived with assisted reproductive technology. Since 1978, ART has contributed to the birth of more than 5 million infants worldwide.

Pediatrics Group Stresses Benefits of Vitamin K Shots for Infants

FEB 28 2022

After the American Academy of Pediatrics (AAP) began recommending vitamin K shots for newborns in 1961, infant bleeding as a result of vitamin K deficiency plummeted. The life-threatening disorder is so rare that some parents now question the need for injections to safeguard against it. The situation amounts to "a failure of our success," Ivan Hand, MD, a co-author of a new AAP statement on vitamin K, said Much like diseases that can be prevented with vaccines, vitamin K deficiency bleeding isn't top of mind for parents. "It's not something they're aware of or afraid of," he said. In 2019, however, the AAP listed public education about the importance of the shots in its 10 most important priorities. The policy update urges clinicians to bone up on the benefits and perceived risks of vitamin K deficiency, which is essential for clotting, and to "strongly advocate" for the shot in discussions with parents who may get competing messages from their social circles, the internet, and other healthcare professionals. Hand, director of neonatology at NYC Health + Hospitals Kings County in Brooklyn, said clinicians walk a line between educating and alienating parents who favor natural birth processes. "We're hoping that by talking to the families and answering their questions and explaining the risks, parents will accept vitamin K as a necessary treatment for their babies," he said.

Vitamin K does not easily pass through the placenta and is not plentiful in breast milk, the preferred nutrition source for newborns. It takes months for babies to build their stores through food and gut bacteria. Infants who do not receive vitamin K at birth are 81 times more likely to develop late-onset vitamin K deficiency bleeding, which occurs a week to 6 months after birth, according to the Centers for Disease Control and Prevention. One in five babies with the disorder dies and about half have bleeding in the skull that can lead to brain damage.

Obesity, Diabetes in Women Linked to Their Birth Weight

FEB 28 2022

In a study of just over 4000 middle-aged women in China, researchers found: A U-shaped relationship between low, normal, or high birth weight and risk of adult obesity, with the lowest risk at a birth weight of 3000 g (the midpoint of the normal birth weight range of 2500 g to < 3500 g); Risk of type 2 diabetes in normal-weight women was highest in those with a low birth weight and decreased as birth weight increased; Among these middle-aged women, those with a high birth weight had a high obesity rate but a low prevalence of type 2 diabetes, whereas those with a low birth weight had a high obesity rate and a high prevalence of type 2 diabetes; Women with overweight or obesity had a higher prevalence of type 2 diabetes, independent of their birth weight; Women with a lower birth weight and overweight or obesity had the highest prevalence of type 2 diabetes. The results confirmed that overall low birth weight is associated with increased risk of having type 2 diabetes in middle-aged women. The results also showed that overweight or obesity in middle age upped the risk of diabetes, independent of birth weight.

LGBTQ Parents Fare Worse Giving Birth

FEB 28 2022

Members of the LGBTQ community who give birth appear to have a greater risk of hypertensive disorders of pregnancy and postpartum hemorrhage, according to new research presented at the annual meeting sponsored by the Society for Maternal-Fetal Medicine.

“Our study found that birthing patients in likely sexual and gender minority partnerships experienced disparities in clinical outcomes,” Stephanie Leonard, PhD, an epidemiology and biostatistics instructor at the Stanford (Calif.) University division of maternal-fetal medicine and obstetrics, told attendees at the meeting. The disparities are likely because of various social determinants and possibly higher use of assisted reproductive technology (ART). The findings establish “how these are significant disparities that have been largely overlooked and set the groundwork for doing further research on maybe ways that we can improve the inclusivity of obstetric care.” Jenny Mei, MD, a maternal-fetal medicine fellow at the University of California, Los Angeles, who attended the presentation but was not involved in the research, said the findings were “overall unfortunate but not surprising given the existing studies looking at LGBTQ patients and their poorer health outcomes, largely due to lack of access to health care and discrimination in the health care setting.” Leonard described the societal, interpersonal, and individual factors that can contribute to health disparities among gender and sexual minority patients.

“At the societal level, there are expectations of what it means to be pregnant, to give birth, and to be a parent. At the community level, there’s the clinical care environment, and at the interpersonal level, there’s an obstetrician’s relationship with the patient,” Leonard said. “At the individual level, most notably is minority stress, the biological effects of the chronic experience of discrimination.” It has historically been difficult to collect data on this patient population, but a change in the design of the California birth certificate made it possible to gather more data than previously possible. The updated California birth certificate, issued in 2016, allows the parent not giving birth to check off whether they are the child’s mother, father, parent, or “not specified” instead of defaulting to “father.” In addition, the parent giving birth can select mother, father, parent or not specified instead of being “mother” by default. The researchers classified sexual and gender minority (SGM) partnerships as those in which the parent giving birth was identified as the father and those where both parents were identified as mothers. Non-SGM minority partnerships were those in which the birthing parent was identified as the mother and the non-birthing parent was identified as the father.

Pregnancy Outcomes Improving After Treatment for High-Grade Cervical Neoplasia

FEB 15 2022

The risk for pregnancy-related complications following treatment for grade-3 cervical intraepithelial neoplasia (CIN 3) has declined over time, thanks to advances in treatment, a new study indicates. However, women treated for CIN 3 should still be managed as "high risk" to reduce risk of preterm birth, infant sepsis, and other adverse outcomes, researchers write in Annals of Internal Medicine. Treatment for CIN 3 removes or destroys part of the cervix and might subsequently influence pregnancy outcomes. However, over the years, treatment for CIN 3 has advanced, with more conservative treatment methods used today. The researchers used data from five national Swedish registries to investigate pregnancy outcomes in women diagnosed with CIN 3 between 1973 and 2018. They identified 78,450 births after a maternal CIN 3 diagnosis and matched them to 784,500 births to women without a CIN 3 diagnosis. Even after accounting for family factors, a history of treatment for CIN 3 was significantly associated with adverse pregnancy outcomes, including preterm birth, especially extremely preterm (odds ratio, 3.00) or spontaneous preterm (OR, 2.12); infection-related outcomes, including chorioamnionitis (OR, 3.23) and infant sepsis (OR, 1.72); and early neonatal death (OR, 1.83). A sibling-comparison analysis that included 23,199 babies born to women diagnosed with CIN 3 and 28,135 born to their sisters without a CIN 3 diagnosis rendered largely similar results. Of note, say the researchers, the risk for all pregnancy complications in women treated for CIN 3 declined over the 46-year study period time and the risk for infant death disappeared. A possible explanation for this is less-invasive treatment methods for CIN 3. "Our results indicate that caution should be taken when applying a screen-and-treat approach to women of reproductive age, given that over treatment of the cervix may have a detrimental effect on future pregnancies," write Dr Wei He with Karolinska Institutet in Stockholm and colleagues. "In the context of a screen-and-treat strategy in countries where diagnostic resources are limited, patients are often treated after a positive result on a screening test, without additional diagnostic confirmation. As such, a large proportion of women with low-grade lesions or with a healthy cervix may be treated unnecessarily, which may consequently lead to adverse outcomes in future pregnancies," they caution.

Perinatal Deaths From COVID Show 'Extensive' Placental Damage

FEB 15 2022

Recent evidence has shown women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how. Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes "widespread and severe" destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID, and that all the women in the study had not been vaccinated against the disease. The findings were published online today in the Archives of Pathology & Laboratory Medicine. Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood; death of cells in the trophoblast; and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition. The researchers called the extent of damage "striking," affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage "was extensive and highly destructive," they write. Notably, none of the women in the analysis was known to have severe COVID.

Endometriosis Not Linked With Preterm Birth, New Study Finds

FEB 15 2022

Researchers evaluating whether endometriosis is linked with preterm birth found no such association in a multicenter cohort study of more than 1300 women. These new findings, which were published online in JAMA Network Open, suggest that changing monitoring strategies to prevent preterm birth for women with the disease may not be necessary. The research team, led by Louis Marcellin, MD, PhD, with the Department of Obstetrics and Gynecology at Université de Paris, in France, also found that disease phenotype or whether the preterm birth was induced or spontaneous did not appear to alter the result. Those results differ from previous research. Data on the phenotypes and their link with preterm birth have been scarce, but previous studies have shown the risk for preterm birth is more pronounced in women who have deep endometriosis than in women with ovarian endometriosis. Marcellin said, "Little is known about the impact of endometriosis on obstetric outcomes. In contrast to previous studies, we reported no differences in the risk for preterm delivery between women with endometriosis (34 of 470 [7.2%]) and those without endometriosis (53 of 881 [6.0%]), even when adjusted for multiple factors." The authors accounted for mother's age, body mass index before pregnancy, birth country, number of times the woman had given birth, previous cesarean delivery, and history of preterm birth. After adjusting for potential confounders, endometriosis was not associated with preterm birth (adjusted odds ratio, 1.07; 95% CI, 0.64 – 1.77). The researchers found no differences among preterm births based on a mother's endometriosis phenotype. Those phenotypes include Isolated superficial peritoneal endometriosis, ovarian endometrioma, and deep endometriosis. "Monitoring pregnancy beyond the normal protocols or changing management strategies may not be warranted in cases of endometriosis," Marcellin said.

Vaginal Progesterone for Preterm Birth Has Mixed Results

FEB 15 2022

The potential effectiveness of using vaginal progesterone to prevent preterm birth in two different populations was the focus of a pair of studies with mixed results at the annual meeting sponsored by the Society for Maternal-Fetal Medicine. One study found no benefit from vaginal progesterone in those with first trimester bleeding, while the other, in a head-to-head comparison with 17-alpha-hydroxyprogesterone caproate (17-OHPC), found vaginal progesterone performs similarly to 17-OHPC in singleton pregnancies with a history of preterm birth. While the first study does not suggest any changes in clinical practice, the second one suggests that vaginal progesterone is an alternative to 17-OHPC, as the American College of Obstetricians and Gynecologists currently recommends. SMFM currently only includes 17-OHPC in its guidelines. “In otherwise low-risk pregnancies with first trimester bleeding, progesterone should not be prescribed for the prevention of miscarriage or prematurity,” Haim A. Abenhaim, MD, MPH, of the Jewish General Hospital at McGill University, Montreal, told attendees in his presentation. ”Publishing the negative result is so important because this helps the overall body of literature reduce the amount of publication bias that exists in the literature,” Michael Richley, MD, an ob.gyn. and maternal-fetal medicine fellow at the University of California, Los Angeles, said in an interview. Dr Richley was not involved in the research but attended the presentation. Most preterm birth occurs in pregnancies with no identifiable risk factors, but first-trimester bleeding may indicate subchorionic hemorrhage from placental detachment, which can increase the risk of preterm birth. Other risk factors where progesterone has previously shown effectiveness in reducing preterm birth risk include short cervix and a history of prior preterm birth. The first study (PREEMPT) was a double-blind, randomized controlled trial conducted at six Canadian hospitals with 533 women. The participants all experienced bleeding within the first 14 weeks of pregnancy and a documented subchorionic hemorrhage. The trial excluded those who already required progesterone, had contraindications to progesterone or had an alternate cause of bleeding. The intervention group included 264 women randomly assigned to use 200 mg of micronized progesterone administered with a vaginal suppository at bedtime, while the placebo group included 269 women who used a vaginal suppository with no medication, both administered until 34 weeks of pregnancy. The groups were not significantly different in age, race, or former pregnancies, live births, and miscarriages. They were also similar in clinical characteristics of bleeding and subchorionic hemorrhage.

Data Suggests B. infantis EVC001 Improves Preterm HMO Utilization

JAN 31 2022

A study published in January in Frontiers in Pediatrics shows B. infantis EVC001 is well-tolerated and improves human milk oligosaccharide utilization in preterm infants in the neonatal intensive care unit. Not all infants carry specialized gut microbes such as Bifidobacterium infantis (B. infantis), meaning they cannot fully digest human milk oligosaccharides (HMOs), an important constituent of human milk. In fact, according to one analysis of samples taken from across the United States, more than 90% of infants studied were not seeded with B. infantis. Research has shown that B. infantis EVC001 converts the full array of HMOs in human milk into compounds usable by the infant, making it an ideal candidate to stabilize gut function and improve nutrition in preterm infants. A prospective, open-label study was conducted at one of the most technologically advanced NICUs in the nation to evaluate the tolerability of B. infantis EVC001 and its effects on the fecal microbiota in preterm infants in the NICU. “This study clearly establishes the tolerability of activated B. infantis EVC001 in preterm infants,” said Dr Sarah Bajorek, DO, neonatologist and co-lead author of the study. “There is so much upside to activated B. infantis EVC001 effectively populating the infant intestine, as it can potentially outcompete pathogenic bacteria and improve the health of infants.” The study followed 30 preterm infants divided into two matched groups. Fifteen control infants received no EVC001 and 15 infants received once-daily feedings of B. infantis EVC001 (8.0 x 10 9 CFU) in MCT oil. Control infants were discharged before enrollment of EVC001 group to reduce cross-colonization. Clinical information regarding medications, growth, nutrition, gastrointestinal events, diagnoses, and procedures was collected throughout admission. Infant stool samples were collected at baseline, Study Days 14 and 28, and 34-, 36-, and 38-weeks of gestation to assess the taxonomic composition of the fecal microbiota, functional microbiota analysis, B. infantis, and excretion of human milk oligosaccharides (HMOs). Researchers found no adverse events or tolerability issues related to EVC001. Moreover, control infants had no detectable levels of B. infantis, while EVC001 infants achieved high levels of B. infantis by Study Day 14, correlating with fewer fecal HMOs, indicating better HMO utilization in the gut. To conclude, B. infantis EVC001 was shown to be safe, well-tolerated, and efficient in colonizing the preterm infant gut, able to increase the abundance of bifidobacteria that metabolizes HMOs, resulting in significantly improved utilization of human milk. “This study further builds strain-specific evidence regarding the safety and tolerability of activated B. infantis EVC001,” said Rebbeca Duar, PhD, co-lead author of the study and Principal Scientist at Evolve BioSystems. “This study is a positive step in setting the stage for future research into the potential health benefits of the single-strain probiotic B. infantis EVC001 in the hospitalized infant population.”

After Preterm Birth, Family Care May Boost Dads' Mental Health Too

Jan 28 2022

After the birth of a preterm baby, new fathers appear to derive as much benefit from a family-integrated-care model in the neonatal ward as do new mothers, with less stress and improvements in mental health, according to a prospective study conducted in the Netherlands. "Integrating the family as a relevant and irreplaceable part of the health care team and creating an environment welcoming continuous parental presence and active participation in neonatal care, or family integrated care (FICare), has been shown to be beneficial for mothers and their newborns," the study team explains in JAMA Network Open. But during the newborn's stay, fathers often feel anxious and excluded from the baby's care and decision-making and few studies and interventions have focused on their mental health and participation in neonatal care, they point out. To investigate, Dr Anne van Kempen of the Department of Pediatrics and Neonatology at OLVG, in Amsterdam, and colleagues enrolled 263 fathers of preterm newborns staying in the hospital for more than one week; 126 were enrolled in a FICare model consisting of single family rooms with couplet-care for the mother and newborn and 137 were enrolled in standard neonatal care (SNC) in open bay units. Mental health and parent-participation surveys were completed by 89 fathers in FICare (71%; mean age, 35 years) and 93 fathers in SNC (68%; mean age, 36 years). At discharge, FICare fathers perceived less stress (adjusted beta, -10.02; 95% CI, -15.91 to -4.13) and potentially participated more in caring for their newborns (adjusted odds ratio, 3.4; 95% CI, 0.86 to 5.988) compared with fathers in standard neonatal care, the researchers report. This FICare model allows fathers to "participate more, which is associated with fewer depressive symptoms and better parent-newborn bonding," they note in their paper. Regardless of the neonatal unit's architectural design, fathers should be supported to actively participate in all aspects of care of preterm newborns, the researchers say. "Fathers should be enabled and supported to participate actively in all aspects of newborn care, and NICU care culture should be tailored to participation and the needs of fathers regardless of architectural design of the neonatal unit," they add.

At-Home Cervical Ripening Safely Shortens Inpatient Labor

Jan 28 2022

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found. The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to "create and adhere to evidence-based guidelines" for outpatient balloon use, according to the researchers. "Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients, and labor and delivery units," the authors reported in Obstetrics and Gynecology. The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours. The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the "most comprehensive" examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say. The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity. Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion.

Alternative Birthing Practices Tied to Neonatal Infection Risk

Jan 28 2022

Increasingly popular alternative peripartum practices such as water immersion and nonseverance of the umbilical cord may increase the risk of infections in newborns, a new clinical report from the American Academy of Pediatrics found. Another perinatal measure potentially raising infection risk was placentophagy, according to a review led by Dawn Nolt, MD, MPH, a professor of pediatric infectious diseases at Oregon Health & Science University, Portland. “Awareness of emerging alternative peripartum and neonatal practices helps pediatricians provide counseling to families before birth and to appropriately evaluate and treat neonates who have been exposed to these practices,” Dr. Nolt and colleagues wrote online in Pediatrics. Amid growing inquiries made from women seeking a positive and meaningful birth experience through alternative approaches as well as reports of possibly related illness in newborns, Dr. Nolt’s group reviewed observational studies, case series, and medical society guidance on the risks associated with seven alternative birthing practices. Based on their summation, it was not possible to quantify the actual risk associated with any one practice. “But of the seven we reviewed, as an infectious disease pediatrician I would say the most discernible immediate risk is likely attached to nonseverance of the cord,” Dr Nolt said in an interview. “Left attached, the tissue can potentially necrote and transfer bacteria directly to the child.”

Abdominopelvic Surgery Risks in Pregnancy Vary by Gestational Age, Indication

Jan 28 2022

Abdominopelvic surgery for non-obstetric reasons is often necessary during pregnancy and the risk of harm to the fetus varies by gestational age, indication and acuity, according to a large meta-analysis. The analysis included 114 observational studies with more than 67,000 pregnant women undergoing non-obstetric abdominopelvic surgery, including appendectomy (52 studies), adnexal (34 studies), cholecystectomy (eight) and mixed surgery types (20). Overall pooled proportions of fetal loss, preterm birth and maternal mortality were 2.8%, 9.7% and 0.04%, respectively. "Rates of fetal loss and preterm birth were higher for pelvic inflammatory conditions (e.g. appendectomy, adnexal torsion) than for abdominal or non-urgent conditions (e.g. cholecystectomy, adnexal mass," the study team reports in Annals of Surgery. "Surgery in the second and third trimester was associated with lower rates of fetal loss (0.1%) and higher rates of preterm birth (13.5%) than surgery in the first and second trimester (fetal loss 2.9%, preterm birth 5.6%)," they say. "This is the most comprehensive systematic review and meta-analysis of adverse fetal and maternal outcomes following non-obstetric abdominopelvic surgery to date," note Dr Maria Cusimano of the University of Toronto, Canada, and colleagues. "Our pooled estimates identify clinical scenarios with the highest risk of adverse fetal outcomes following surgery; while we are unable to provide specific management recommendations due to the nature and quality of studies identified, these data may help multidisciplinary teams tailor mitigation strategies," they write. These strategies may include use of tocolytics and/or corticosteroids perioperatively; consideration of pre-emptive elective surgery (e.g. for adnexal masses at substantial risk of torsion); and deferral of surgery to the second trimester when safely possible, the researchers say.

At-Home Cervical Ripening Safely Shortens Inpatient Labor

JAN 14 2022

Women who undergo balloon cervical ripening at home spend less time in the labor and delivery unit and have fewer cesarean deliveries than those who have the induction procedure in a hospital, researchers have found. The findings, from a meta-analysis of eight previously conducted randomized clinical trials involving 740 women, should spur hospitals to "create and adhere to evidence-based guidelines" for outpatient balloon use, according to the researchers. "Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients, and labor and delivery units," the authors reported. The rate of labor induction in the United States rose to 29.4% in 2019, the year following publication of the ARRIVE trial of low-risk nulliparous pregnant women, which found that induction at 39 weeks resulted in fewer cesarean deliveries with no difference in neonatal outcomes compared with expectant management, defined as continuing pregnancy until at least 40 weeks 5 days unless induction was medically indicated. Most women require preparation with a balloon-tipped catheter that slowly inflates to stretch and thin out the cervix, a process that can take many hours. The devices have been shown to be safe, effective, and inexpensive, but the data on outpatient use are limited, according to the researchers. The new study is the "most comprehensive" examination of randomized clinical trials comparing outpatient and inpatient balloon cervical ripening, they say. The trials included singleton gestations of at least 37 weeks of primarily low-risk patients. Body mass index was slightly lower in the outpatient group, with no differences in maternal age, gestational age at induction, or parity. Six studies with 571 patients reported on the primary outcome, defined as time from labor unit admission to delivery. The outpatient group had a mean 16.3 hours compared with 23.8 hours for the inpatient group, a difference of 7.24 hours. However, data from three of the studies showed the inpatient group experienced 5.19 hours on average less between balloon expulsion and delivery, potentially due to more frequent adjustments and evaluation for expulsion. The researchers observed no differences in adverse maternal or neonatal outcomes, and no stillbirths were reported among 378 patients who had the outpatient procedure. Cesarean delivery occurred less often in the outpatient group (21%) vs the inpatient group (27%) (risk ratio, 0.76; 95% Cl, 0.59 – 0.98).

COVID-19 Vaccination During Pregnancy Not Linked to Complications at Birth: US Study

JAN 14 2022

COVID-19 vaccination during pregnancy was not associated with preterm delivery or underweight newborns, in a study published by the US Centers for Disease Control and Prevention (CDC). Rates of preterm birth were 4.9% among more than 10,000 women who received at least one dose of a COVID-19 vaccine, compared to 7.0% for roughly 36,000 unvaccinated women, researchers said. The difference was not deemed to be statistically significant. In addition, COVID-19 vaccination did not increase the risk of delivering a baby who weighed less than usual for the number of weeks of pregnancy, the researchers found. Results from the study support the CDC's recommendation on the safety of COVID-19 vaccination during pregnancy. "Evidence of the benefits of COVID-19 vaccination during pregnancy continues to accrue, including the detection of antibodies in cord blood," the researchers wrote, noting that pregnant women with COVID-19 have increased risks for intensive care unit admission, need for mechanical ventilation and death. The women in the study had become pregnant between May and October of 2020, before vaccines were available. Nearly all who were vaccinated got the shots in their second or third trimester of pregnancy. Some 96% of them had received at least one dose of an mRNA vaccine from either Pfizer Inc (PFE.N) and BioNTech (22UAy.DE), or Moderna Inc (MRNA.O). The remaining women received the single-shot vaccine from Johnson & Johnson (JNJ.N).

Mediterranean Diet, Mindfulness Each Reduce Small-for-Gestational Age Births

JAN 14 2022

Low birth weight affects up to 10% of pregnancies and stems from fetal growth restriction. Until today, no treatment that could improve this condition is available. A study published in JAMA led by researchers from BCNatal (Hospital Clínic-IDIBAPS and Hospital Sant Joan de Déu in Barcelona) with the support of the ”la Caixa” Foundation, has demonstrated for the first time that fetal growth can be improved by maternal lifestyle changes. The study specifically demonstrates a reduction of low birth weight babies up to 29% and 36% by intervening on the mother’s diet and lowering her stress level. The study was coordinated by Eduard Gratacós, director of BCNatal and the Fetal and prenatal medicine group at IDIBAPS and CIBERER, Francesca Crovetto (Hospital Sant Joan de Déu) and Fàtima Crispi (Hospital Clínic), from the Maternal-Fetal Medicine Services of BCNatal and researchers from the same groups. It was conducted in collaboration with the teams of Ramon Estruch, from the Internal Medicine Service at Hospital Clínic, head of the Cardiovascular risk, nutrition and aging group at IDIBAPS and researcher at CIBEROBN; Eduard Vieta, head of the Psychiatry and Psychology Service at Hospital Clínic, from the Bipolar and depressive disorders group at IDIBAPS and scientific director of CIBERSAM, as well as professionals from the esMindfulness Institute, directed by Andrés Martín-Asuero. The project also received the support of CEREBRA, CIBERER and AGAUR. Low birth weight is associated with birth complications and health problems. Low birth weight babies (birth weight below the 10th centile) account for 10% of all births. Low birth weight reflects growth restriction in fetal life, it is recognised by the WHO as one of the most important causes of perinatal mortality worldwide and it is linked to poorer neurodevelopment in childhood and higher risk of metabolic and cardiovascular health problems in adulthood. No treatment had existed until now that could prevent or improve this condition. The research team led by Dr Eduard Gratacós has been studying the possible causes and consequences of low birth weight for many years. “We saw that mothers of low birth weight newborns often had a suboptimal diet and high stress levels,” explains Dr Gratacós. This led to the idea of conducting a clinical trial to study whether structured interventions based on Mediterranean diet or stress-reduction could reduce fetal growth restriction and other pregnancy complications.

Neonatal Sepsis: WHO-Recommended Rx Needs a Major Rethink

JAN 14 2022

First-line treatment of neonatal sepsis in low- and middle-income countries (LMICs) with ampicillin-gentamicin — as recommended by the World Health Organization (WHO) — needs to be reassessed, a retrospective, observational cohort study suggests. Rates of resistance to this particular antibiotic combination are extremely high in LMICs, and this treatment is unlikely to save many neonatal patients, according to the study's results. "The WHO guidelines are over 10 years old, and they are actually based on high-income-country data, whereas data reported from low-income countries are reported by private labs, and they do not cater to the lower socioeconomic groups within these countries, which is important data to capture," Timothy Walsh, MD, University of Oxford, Oxford, United Kingdom, said. "The main take-home message from our data is that ampicillin-gentamicin doesn't work for most of the Gram-negative isolates we tested, and while there are alternatives, their use is confounded by [a lack of] financial support," he added. In this substudy of the Burden of Antibiotic Resistance in Neonates from Developing Societies (BARNARDS) study, investigators focused on the effectiveness of antibiotic therapies after taking into account the high prevalence of pathogen resistance to ampicillin-gentamicin. Participating countries included Bangladesh, Ethiopia, India, Nigeria, Pakistan, Rwanda, and South Africa. "Blood samples were obtained from neonates presenting with clinical signs of sepsis," the authors note, "and WGS [whole-genome sequencing] and MICs [minimum inhibitory concentrations] for antibiotic treatment were determined for bacterial isolates from culture-confirmed sepsis." Between November, 2015, and February, 2018, 36,285 neonates were enrolled into the main BARNARDS study, of whom 9874 had clinically diagnosed sepsis and 5749 had antibiotic data. A total of 2483 neonates had culture-confirmed sepsis, and WGS data were available for 457 isolates taken from 442 neonates. Slightly over three quarters of the 5749 neonates who had antibiotic data received first-line ampicillin-gentamicin. The other three most commonly prescribed antibiotic combinations were ceftazidime-amikacin, piperacillin-tazobactam-amikacin, and amoxicillin-clavulanate-amikacin. Neonates treated with ceftazidime-amikacin had a 68% lower reported mortality than those treated with ampicillin-gentamicin at an adjusted hazard ratio (HR) of 0.32 (95% CI, 0.14 – 0.72; P = .006), the investigators report. In contrast, no significant differences in mortality rates were reported for neonates treated with amoxicillin-clavulanate-amikacin or piperacillin-tazobactam-amikacin compared to those treated with ampicillin-gentamicin.

Surprising Data on Neurodevelopment of Babies Born During the Pandemic

JAN 14 2022

Columbia researchers found that babies born during the pandemic’s first year scored slightly lower on a developmental screening test of social and motor skills at 6 months—regardless of whether their mothers had COVID during pregnancy—compared to babies born just before the pandemic. The study which included 255 babies born at NewYork-Presbyterian’s Morgan Stanley Children’s Hospital and Allen Hospital between March and December 2020, was published in the journal JAMA Pediatrics. “Infants born to mothers who have viral infections during pregnancy have a higher risk of neurodevelopmental deficits, so we thought we would find some changes in the neurodevelopment of babies whose mothers had COVID during pregnancy,” says Dani Dumitriu, MD, PhD, assistant professor of pediatrics and psychiatry at Columbia University Vagelos College of Physicians and Surgeons and lead investigator of the study. “We were surprised to find absolutely no signal suggesting that exposure to COVID while in utero was linked to neurodevelopmental deficits. Rather, being in the womb of a mother experiencing the pandemic was associated with slightly lower scores in areas such as motor and social skills, though not in others, such as communication or problem-solving skills. The results suggest that the huge amount of stress felt by pregnant mothers during these unprecedented times may have played a role. “These were not large differences, meaning we did not see a higher rate of actual developmental delays in our sample of a few hundred babies, just small shifts in average scores between the groups,” Dumitriu says. “But these small shifts warrant careful attention because at the population level, they can have a significant public health impact. We know this from other pandemics and natural disasters.”

New York First to Add G6PD Deficiency to Routine Screenings

JAN 11 2022

New York State became the first state in the nation to add G6PD Deficiency to routine newborn screenings today, as New York State Governor Kathy Hochul signed the Brody James Bill into law. The bill, supported by The g6pd Deficiency Foundation, was named for two people whose lives were altered because G6PDd was not diagnosed until after it had caused severe health impacts. G6PDd (short for Glucose-6-Phosphate Dehydrogenase Deficiency) is the most common human enzyme disorder, affecting upwards of an estimated 400 million people worldwide and up to 6% of newborns in the US. G6PD Deficiency can have life-altering effects if it’s not caught early and proactively controlled. “We are so grateful to Governor Hochul, as well as Senator Rivera and Assemblyman Gotfried, for helping us make New York State a safer place for newborns and their families through the Brody James Bill,” said Keely Harris, Founder and President of The g6pd Deficiency Foundation. “I'm proud that this law will honor my grandson’s journey and help prevent G6PDd from causing life-changing injuries to other children like him. New York State has once again proven itself to be a leader on children's health issues, and we hope to see other states follow its example so that families around the country might have some protection from the life-threatening crises caused by G6PDd.” The bill, introduced by State Senator Gustavo Rivera and Assemblyman Richard Gotfried, is the first of its kind in the United States, although many countries around the world include this screening for newborns, as does the U.S. military as part of its routine medical assessment. It was inspired by the story of Keely’s now 8-year-old grandson Brody and another individual, James, who recently passed at 20 years old, due to complications from brain damage, caused by undiagnosed G6PDd as a newborn. In Brody’s case, after a harrowing experience with undiagnosed G6PD Deficiency that led to kernicterus, 1-week old Brody suffered brain damage that could have been avoided if he were screened at birth and diagnosed before he was discharged from the hospital. In response to the family’s ordeal, and in honor of her grandson’s ongoing battle, Keely founded The g6pd Deficiency Foundation which aims to raise awareness for the disease for both families and medical professionals and promotes newborn screenings as a life-saving tool. G6PD deficiency is an inherited genetic enzyme disorder that impacts the mechanism by which the body is able to process glucose. The majority of individuals who are G6PD deficient have no obvious clinical symptoms in the absence of “triggers” (such as primaquine or a reaction to fava beans) and are often unaware that they have this deficiency. G6PD deficiency has, however, the potential to cause attacks of acute hemolytic anemia, severe neonatal jaundice that can lead to kernicterus, and, more rarely, chronic anemia called Chronic Non-Spherocytic Hemolytic Anemia (CNSHA). A letter supporting the bill, written and signed by Dr. Richard O. Francis, Associate Professor, Department of Pathology & Cell Biology, Columbia University VP&S and Director of Special Hematology and Coagulation Laboratory at New York-Presbyterian Hospital-Columbia University Irving Medical Center stated, “Because testing for G6PD deficiency is not a part of New York State newborn screening, many times the infant who is not known to be G6PD-deficient is already at home while hyperbilirubinemia is developing and brain damage is occurring. Prior to the infant’s discharge from the hospital, if the clinician knew that the newborn was G6PD deficient, proper treatment and parental education could occur, thereby preventing the development of kernicterus. A lifetime of unexplained sickness and unnecessary hospitalizations could be avoided for the infant and his or her family members if screening for G6PD deficiency is performed at birth.” G6PD Deficiency is more common in families with Mediterranean, Asian or African ancestry and disproportionately impacts minority communities. However, in the 21st century, ancestry is not always known or clear. In absence of a screening or parental blood tests specifically for this genetic mutation, it is impossible to identify a G6PD deficient person. Adding universal screenings for G6PDd to the newborn screening list, along with Cystic Fibrosis and Sickle Cell Disease, would allow it to be diagnosed and treated early, saving lives, and sparing families unnecessary pain.

Fetal Gut May Have Insulin-Producing Cells That Shut Off at Birth

DEC 30 2021

In addition to pancreatic beta cells that secrete insulin, researchers have found that fetal cells in the gut secrete insulin proteins, but neonatal cells do not, suggesting that this ability is turned off at birth. The study findings are "plausible, because the pancreas and the small intestine originate from the same tissue in the growing fetus at about the fifth week of gestation," said senior study author Shalev Itzkovitz, PhD, principal investigator, Weizmann Institute of Science, in Rehovot, Israel, in a news story in The Jerusalem Post. The study by Adi Egozi, a PhD student at the Weizmann Institute of Science and colleagues in Israel and in the United States, was recently published in Nature Medicine. The researchers speculated that if they could get cells in adults to secrete insulin proteins, this might lead to a new way to treat diabetes, but this research is very preliminary. "We found insulin-producing cells in fetuses, yet not in neonates," Itzkovitz summarized in an email. "It would be exciting to uncover situations where the insulin-producing cells naturally re-appear, eg, in diabetes, gastric bypass, or other perturbations," and to "identify molecules that could awaken the beta-like state we discovered,” Itzkovitz added. The study findings "highlight a potential extra-pancreatic source of beta cells and expose its molecular blueprint," the researchers summarize. "The dream is to have a drug that could re-awaken the fetal insulin-expressing program," Itzkovitz said. "Even though the insulin-producing cells are a minority, the gut surface is huge, and their numbers add up," he noted. In addition, "gut cells are constantly replaced via divisions of stem cells." "This means that the impact of autoimmune attack in type 1 diabetes might be less pronounced on intestinal insulin-producing cells," according to Itzkovitz.

Delayed Umbilical Cord Clamping Improves Outcomes in Very Preterm Infants

DEC 30 2021

Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants. The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted. In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group. Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand. By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote. The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted. However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.

Spreading Holiday Cheer: NICU Babies 'Sleigh-ing It' in Ugly Sweaters

DEC 30 2021

Holiday merriment in a place often associated with trauma is part of the festivity of the winter season at Tallahassee Memorial HealthCare (TMH) in Tallahassee, Florida. As is their tradition, the nurses in the neonatal intensive care unit (NICU) at TMH dressed up their newborn patients in holiday attire. This year, they chose the "ugly sweater" look for the tiniest of hospital stayovers. About 20 baby photos grace the hospital's Facebook page, starting with a Grinch baby and ending with one dressed as a candy cane. The photos are "live and full of just as much cuteness as ever," marketing representative Morgan King said. The Facebook post, in keeping with custom, was full of puns to keep spirits high around an otherwise stressful environment. For starters: "There's snow way we would miss our favorite holiday tradition! This year, our NICU babies are sleigh-ing it in their ugly Christmas sweaters." An explanation beside the Grinch photo stated: "These NICU babies are so cute, they made our hearts grow three sizes." Another photo joked: "What's a snowman's favorite hot drink? Frost-tea." And aside a baby sporting a Christmas-tree costume: "We hope these babies really light up your day." The post continued, "Thank you to our incredible NICU team who always go above and beyond to make the holidays special for our NICU families. The sweaters were hand-made by our NICU team to help these little cuties and their families get in the holiday spirit." The parents of all babies pictured consented to their children being dressed up and photographed, the post further clarified. Earlier this year, NICU nurses took to Facebook with festive Halloween costumes for the babies under their care in a post that went viral, attracting national headlines. TMH has the only NICU and high-risk labor and delivery unit in the region, King said. "In addition to providing sick and premature babies the highest level of specialized care, our team works to make the NICU environment as comfortable as possible for our babies and families," she said. "Having a baby in the NICU can be unexpected and challenging for families, making the holidays feel less merry. Bringing the festive fun to these little ones and their parents through this annual tradition is just one of the many ways our team works to normalize the NICU environment and make an uncertain time special for families. Our crafty NICU night team created the sweaters and our day team helped bring their visions to life." Among the comments under the post, one visitor shared: "Praying for these special little ones and their families! They are rocking the sweaters!" The post ended with a disclaimer to use caution with fragile little ones. "Please remember, you should always place your little ones on their backs to sleep, with nothing else in the crib. These NICU babies have special circumstances and are monitored 24/7 by our skilled nursing team."

Program Assists Substance-Exposed Infants, Their Caregivers

DEC 30 2021

Pregnant with her second child, Clarissa Collins was at her methadone clinic when a woman walked in with a box of doughnuts and a baby doll. The woman, Tara Sundem, was partway through a five-year effort to open Hushabye Nursery and launch a novel family-focused program that would treat substance-exposed infants and offer care and support to their caregivers. Hushabye Nursery recently celebrated one year in its current care facility in Phoenix and Collins now works there as a peer support specialist, helping others in recovery, the Arizona Capitol Times reported. The center houses a 12-room inpatient nursery for infants suffering from neonatal abstinence syndrome – newborns experiencing withdrawal from opioids they were exposed to in the womb, such as heroin and prescription painkillers. But on that day in 2019, Collins begrudgingly attended Sundem’s support group for pregnant women with opioid use disorder. By the second group meeting, she decided to come back every week. “I looked forward to it. I wanted to see the other girls; I wanted to hear their stories. I wanted to meet the baby,” Collins said. “And we became this little family. We became very close friends.” As the opioid epidemic worsens nationwide, neonatal abstinence syndrome (NAS) cases are increasing, too. Nationally, the number of babies born with the condition increased 82% from 2010 to 2017, according to the Centers for Disease Control and Prevention. The national trend in NAS cases holds true in Arizona and has worsened since the Covid pandemic began. Arizona’s NAS rate in 2020 was 9.1 per 1,000 newborn hospitalizations, up from 5.67 per 1,000 in 2015, according to Arizona Department of Health Services vital statistics reports. In 2010, that figure was 2.65 per 1,000. Some of the increase can be attributed to better reporting and other factors, not the opioid epidemic itself, said Sara Rumann, with the department’s Bureau of Women’s and Children’s Health. “But we can say overall the general trend is that it has increased over the last 10 years,” Rumann said.

Fertility Treatments Not Linked to Psychiatric Disorders in Offspring

DEC 30 2021

Some reassuring findings for people pursuing assisted reproduction: babies born through the fertility procedures do not appear to be at increased risk of developing major psychiatric illnesses as they move through adolescence and into adulthood. The results, reported in JAMA Psychiatry, come from an analysis of more than 31,000 people conceived via assisted reproduction techniques (ART) in Sweden between 1994 and 2006. The researchers, from Sweden and the United States, found that in this group, rates of depression and suicidal behaviors were not elevated compared with the general population. "We welcome null findings in our study," said Chen Wang, MPH, a doctoral student at the Karolinska Institutet (KI) in Stockholm, and the lead author on the study. "Overall we found no greater concern for poorer psychiatric health in adolescents conceived with ART compared with the general population, except for an elevated risk of OCD [obsessive-compulsive disorder] that may be explained by differences in parental characteristics." "Couples and individuals undergoing or considering ART can indeed be reassured in the sense that our study found no indication that the treatment per se could make children vulnerable to poor mental health later in life," added Anna Sara Öberg, MD, PhD, the senior author of the paper, who holds appointments in epidemiology at the KI and the Harvard T.H. Chan School of Public Health, in Boston. ART has been linked to several potentially unwanted outcomes, including birth defects, preterm delivery, low birth weight, imprinting disorder, and possibly neurodevelopmental disorders. Previous research from Wang's team showed that children conceived with ART do not appear to be more likely to have attention-deficit/hyperactivity disorder or poor school performance than children conceived spontaneously. The new study expands on that earlier work, which was published this year in the journal Pediatrics. From a Swedish database of more than 1.2 million people born between 1994 and 2006, Wang's group identified 31,565 individuals born via ART ― defined as in vitro fertilization with or without intracytoplasmic sperm injection and transfer of fresh or frozen-thawed embryos ― during that period. At the time of final follow-up, in December 2018, participants in the study were between the ages of 12 and 25 years. To assess the risk of mental illness, the researchers looked for diagnoses in medical records from hospitals and outpatient clinics. They also included death certificates, to determine if suicide was the cause, and prescriptions of antidepressants to see if patients were being treated for depression.

Infant Milk Allergy Guidelines Promote Overdiagnosis, Study Says

DEC 15 2021

International guidelines developed to help doctors diagnose cow's milk allergy may lead to over-diagnosis, according to University of Bristol-led research published in the journal Clinical and Experimental Allergy. The study found that three-quarters of infants have two or more symptoms at some point in the first year of life which guidelines say may be caused by cow's milk allergy, yet the condition only affects one in 100. Cow's milk allergy can present with either acute or delayed symptoms. Delayed symptoms are more varied and include gut and skin symptoms, such as posseting (bringing up milk) and vomiting, colic, loose stools or constipation, and flaring of eczema. Many of these symptoms are already known to be common in infants, making delayed cow's milk allergy difficult to diagnose. Researchers found that one in four parents reported two or more possible "mild to moderate" symptoms every month. Symptoms were most numerous at three months of age, when all children were fully breastfed and not directly consuming cow's milk. At six months of age, there was no difference in the number of children with two or more symptoms between those consuming and not consuming cow's milk. Together, these findings suggest that the majority of symptoms listed in cow's milk allergy guidelines are common, normal and not caused by cow's milk allergy. Dr Rosie Vincent, Honorary Clinical Research Fellow at the Centre for Academic Primary Care, University of Bristol who led the research, said: "Guidelines, designed to help the non-specialist to diagnose cow's milk allergy in infants may unintentionally medicalise normal infant symptoms and promote over-diagnosis of cow's milk allergy." Senior co-researcher and children's allergy doctor, Dr Michael Perkin, from the Population Health Research Institute at St George's, University of London, added: "Our findings come against a background of rising prescription rates for specialist formula for children with cow's milk allergy, which is completely out of proportion to how common we know the condition is. Parents of young infants are often seen in clinics, worried about a medical cause for their infant's symptoms such as colic, bringing up milk or loose stools. However, our research confirms that these symptoms are extremely common. In an otherwise healthy infant, an underlying cause is unlikely. Incorrectly attributing these symptoms to cow's milk allergy is not only unhelpful, but it may also cause harm by discouraging breastfeeding." The researchers (from the University of Bristol, St George's, University of London, Imperial College London, King's College London, and St John's Institute of Dermatology), used data from the Enquiring About Tolerance study of 1,303 infants aged between three and twelve months, in which parents were asked to record any symptoms their child experienced on a monthly basis. They counted how many infants had cow's milk allergy symptoms each month, as defined in the international Milk Allergy in Primary Care (iMAP) guideline.

Negative Confirmatory Trial Did Little to Drive Down Use of Questionable Preterm Drug

DEC 15 2021

Use of hydroxyprogesterone caproate injection (Makena) for recurrent preterm birth remained high in the U.S. after a "confirmatory" clinical trial failed to show a benefit of the drug, a new analysis indicates.

"Despite the negative trial results and FDA (Food and Drug Administration) efforts to remove the drug from the market, use and spending continue, demonstrating a level of support for the drug among physicians, likely owing to conflicting evidence supporting the drug's use," researchers report in JAMA Internal Medicine. "The FDA has faced difficulties removing accelerated approval drugs from the market even when they fail to show a clinical benefit in their required confirmatory trials," first author Rachel E. Sachs, a professor of law at Washington University School of Law in St. Louis, said. "We wanted to look at whether the publication of negative trial results and statements by the agency or its advisory committees would be sufficient to drive down a drug's use and therefore its spending," she said. "We found that while use and spending did decline after these events, use has remained high, meaning that states may be spending their limited financial resources on products with weak or no clinical benefits," Sachs said. "In other words, issuing statements about the drug's clinical efficacy does not on its own significantly drive down use and spending - the agency does need to take steps to remove the drug from the market in order to have that effect," she added. Makena received accelerated approval in February 2011 based on a clinical trial demonstrating that it reduced the risk of preterm birth in women with previous spontaneous preterm birth. In March 2019, however, results of the FDA-required confirmatory trial failed to replicate the initial trial's reduction in recurrence preterm births. In October 2019, an FDA advisory committee narrowly voted to withdraw approval and a year later the FDA Center for Drug Evaluation and Research (CDER) proposed taking the drug off the market. But Makena's manufacturer requested a hearing, which FDA granted in August 2021. The proceedings remain ongoing. Sachs and colleagues used national Medicaid drug utilization and spending data to examine changes in hydroxyprogesterone caproate fills from 2010 to 2020. They found that use of the drug increased from less than 11,000 fills per quarter between 2010 and 2014 to more than 30,000 fills per quarter in the first quarter of 2019. In the second quarter 2019, after the failed the post-approval trial, there was no decline in use. Between the third and fourth quarters of 2019, use of the drug declined more than 8,000 fills per quarter, coinciding with formal publication of the negative trial and the FDA advisory committee recommendation to withdraw it from the market. A subsequent decline in use was noted in quarter three of 2020, but use remained high at 19,554 fills per quarter (54.9% of the maximum volume reached in the second quarter of 2017). Since the second quarter of 2019, brand name Makena has maintained more than half of market share, despite availability of generic versions of the drug since 2018. Sachs and colleagues say low uptake of the generics may be driven by the newer branded autoinjector formulation of Makena that the FDA approved in February 2018. "The autoinjector has resulted in continued high spending on hydroxyprogesterone caproate, despite generic availability," they note. In the third quarter of 2020 alone, "state Medicaid programs reimbursed (before rebates) $41,872,080 for all forms of hydroxyprogesterone caproate, 73.2% of which was for the Makena autoinjector," they report in their article.

Human Milk Introduced to Japanese Market

DEC 9 2021

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for premature and critically ill infants, announced the enrollment of the first baby into a Japan-based clinical trial evaluating growth and safety associated with an Exclusive Human Milk Diet including Prolacta's 100% human milk-based fortifiers (Prolacta's EHMD). The Japan-based study — "JASMINE: A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants" — began in October 2021. In Japan, Prolacta's human milk-based products will be registered as a drug. "Initiation of this study in Japan is another industry first, being led by Prolacta," said Scott Elster, CEO of Prolacta. "Japan's regulatory authorities have very strict requirements for conducting drug trials. Our industry-leading quality and safety standards meet Pharmaceuticals and Medical Devices Agency. (PMDA) regulations, allowing us the opportunity to conduct this study and introduce an exceptional level of nutritional care for preterm babies in Japan." "We know that Prolacta's EHMD is the gold standard diet for premature infants," said principal investigator, senior professor of pediatrics Dr Katsumi Mizuno, MD, PhD, of the Showa University School of Medicine in Tokyo. "This study is necessary to bring a higher level of nutritional care to our very low birth weight babies in Japan." Mizuno-sensei, in association with a clinical research organization, will oversee the 10-site study taking place at Showa University Hospital, Showa University Koto Toyosu Hospital, Showa University Northern Yokohama Hospital, Nara Medical University Hospital, Saitama City Hospital, Fujita Health University, Tokyo Metropolitan Bokutoh Hospital, Nagano Children's Hospital, Takatsuki General Hospital, and Gifu Prefectural General Medical Center. The study will evaluate three of Prolacta's 100% human milk-based products.

UK Data Show Good Safety of COVID-19 Vaccines in Pregnancy

NOV 30 2021

COVID-19 vaccination is safe for pregnant women and not associated with higher rates of complications, data released by the UK Health Security Agency showed on Thursday, as officials urged pregnant women to take up the offer of shots. The real-world data from the rollout of COVID-19 vaccines in Britain support other studies around the world that the vaccines are safe to give at any stage of pregnancy, the UKHSA said. It found that there were not substantial differences in rates of stillbirths, rates of births of babies with low birthweight and the proportion of premature births between vaccinated women and unvaccinated women. Officials said the data were especially reassuring given that the first pregnant women to be offered the vaccine were those with underlying health conditions who would be expected to be at a higher risk of complications. "Every pregnant woman who has not yet been vaccinated should feel confident to go and get the jab, and that this will help to prevent the serious consequences of catching COVID-19 in pregnancy," said Dr Mary Ramsay, Head of Immunisation at UKHSA. The UKHSA data found that vaccinated women had a stillbirth rate of 3.35 per 1,000, slightly lower than the rate of 3.60 per 1,000 in unvaccinated women. The proportion of women giving birth prematurely was 6.51% for vaccinated people, slightly higher than 5.99% for unvaccinated women. The government is urging pregnant women who have not yet been vaccinated to get their shots. The health ministry said catching COVID-19 came with much bigger risks than having the vaccine, adding that only 22% of women who gave birth in August were vaccinated. It said that 98% of pregnant women in hospital with symptomatic COVID-19 were unvaccinated, and vaccine take-up was lower in deprived areas and some minority groups.

Neonate Rewarming Tied to Increased Electrographic Seizure Risk, Poor 2-Year Outcomes

NOV 30 2021

Neonates with hypoxic ischemic encephalopathy who are treated with hypothermia have an increased risk of seizures during rewarming, and those seizures are associated with greater death and disability at 2 years, a new study suggests. Researchers examined data on 120 newborns at a mean gestational age of 39 weeks who were randomized to receive either 72 hours (n=66) or 120 hours (n=54) of cooling as an intervention for hypoxic ischemic encephalopathy. The primary endpoint was electrographic evidence of seizures during the 12 hours prior to rewarming compared with the first 12 hours of rewarming. Compared with the 12 hours prior to rewarming, infants had significantly greater seizure risk during the first 12 hours of treatment for both 72-hour rewarming (odds ratio 2.7) and 120-hour rewarming (OR 3.2). At ages 18-22 months, the infants who experienced seizures during rewarming had a significantly higher risk of mortality or severe disability (OR 1.7) in adjusted analysis that accounted for baseline clinical encephalopathy and seizures as well as treatment center. "The presence of higher odds of seizures during rewarming that are associated with death and disability at two years is a new and important finding," said lead study author Dr Lina Chalak, a professor of pediatrics and psychiatry and director of the Neonatal Neurological Intensive Care and Fetal and Neonatal Neurology Fellowship Program at the University of Texas Southwestern Medical Center in Dallas. "The underlying mechanisms are likely related to impaired auto-regulation with hemodynamic mismatch between oxygen delivery and metabolic demands during rewarming which precipitates seizures," Dr Chalak said by email. These results suggest that there's a significantly elevated risk of seizures during the rewarming period, most of which typically go unnoticed if not monitored with EEG or amplitude compressed EEG, Dr. Chalak added. For infants randomized to a 72-hour rewarming period, 27% experienced seizures during the first 12 hours of rewarming, compared with 14% in the 12 hours prior to initiation of rewarming. For infants randomized to a 120-hour rewarming period, 21% experienced seizures during the first 12 hours of rewarming, compared with 10% in the 12 hours prior to treatment initiation.

Enriched Infant Formula Offers No Academic Benefit Later: Study

NOV 30 2021

Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests. One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states. So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up. In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores. They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records. They found “no benefit of the infant formula modifications on cognitive outcomes.” In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.

Neonate Rewarming Tied to Increased Electrographic Seizure Risk, Poor 2-Year Outcomes

NOV 15 2021

Hypothermia has been shown to improve long-term outcomes in neonatal hypoxic ischemic encephalopathy compared to normothermia. Despite this, there is room for optimization of care, as 29% of infants continue to have abnormal outcomes at age 18 to 22 months, where data on the risk of seizures during the rewarming phase is limited. This nested cohort study (SMART) assessed the likelihood of electrographic seizures during rewarming at 72 or 120 hours and their association with neurodevelopmental outcomes at 2 years, where it was hypothesized that seizures during rewarming were associated with higher odds of abnormal neurodevelopmental outcomes. The main endpoint was the occurrence of electrographic seizures during rewarming initiated at 72 or 120 hours compared with the preceding 12-hour epoch. Secondary endpoints included death or moderate or severe disability at age 18 to 22 months. Among 120 newborns, higher occurrence of electrographic seizure during the rewarming phase after hypothermia was associated with elevated relative risk of death or disability at 2-year follow-up. This association between seizure occurrence during rewarming and poor neurodevelopmental outcomes supported the American Clinical Neurophysiology Society’s Guidelines of continuous electroencephalography monitoring in neonates with suspected perinatal asphyxia at high risk. In addition to the standard 72-hour duration of hypothermia, it is recommended that monitoring be continued throughout rewarming until normothermia and seizure control has been achieved. A limitation of this study was the lack of hemodynamic evaluation to confirm the underlying mechanisms of electrographic seizures and rule out confounding causes of seizure in neonates.

Enriched Infant Formula Offers No Academic Benefit Later: Study

NOV 15 2021

Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests. One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states. So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up. In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores. They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records. They found “no benefit of the infant formula modifications on cognitive outcomes.” In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron. In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math. “Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.

Drug Used to Prolong Gestation Linked to Increased Cancer Risk in Offspring

NOV 15 2021

Children exposed in utero to 17 alpha-hydroxyprogesterone caproate (17-OHPC) may be at increased risk for cancer, a new study suggests. In an analysis of data from more than 18,000 mother-child pairs, researchers found that, overall, offspring of women who were injected with the synthetic progesterone during pregnancy had nearly double the risk of any cancer compared with those not exposed to the hormone. Exposure during the first trimester carried some of the highest risks for cancers later in life, including for pediatric brain cancer (adjusted hazard ratio 34.72), prostate cancer (aHR 5.10), and colorectal cancer (aHR 5.51), according to the report published in the American Journal of Obstetrics & Gynecology. “Exposure in the womb to a drug used to prevent miscarriage in the 1950s and 60s increases the offspring’s risk of cancer many decades later, especially for prostate, colorectal, and pediatric brain cancer,” said the study’s first author, Caitlin Murphy, an associate professor at the School of Public Health at the University of Texas Health Sciences Center in Houston. “This drug is still available in the United States for pregnant women to prevent preterm birth,” Murphy noted. “We were surprised by the strength of our findings,” Murphy said in an email. “This is newsworthy because rates of several cancers are increasing across generations, starting with persons born in the 1960s or Generation X. Increasing rates of cancer across generations implicate exposures in very early periods of life as risk factors. This is consistent with our finding that earlier and more frequent injections of 17-OHPC in pregnancy was associated with higher risk of cancer in offspring. We need to know if risk of these cancers begins before birth, so that we can better weigh the pros and cons of medications in pregnancy.” While it isn’t known exactly how the drug may raise cancer risk, Murphy says it may be because the drug isn’t an exact duplicate of progesterone. “Synthetic hormones, or drugs made to act like natural hormones, disrupt the way natural hormones work, especially during the vulnerable time of fetal development,” she said. “The potential for synthetic hormones to disrupt development and increase risk of cancer is well-established by studies of diethylstilbestrol, a synthetic estrogen that was commonly prescribed to pregnant women to prevent miscarriage in the 1950s and 60s. 17-OHPC is a synthetic progestogen and may similarly contribute to risk of cancer.” To look at possible impacts of the medication on fetuses, Murphy and her colleagues turned to data from Child Health and Development Studies (CHDS), a population-based cohort of more than 18,000 mother-child dyads receiving prenatal care in the Kaiser Foundation Health Plan (Oakland, CA) between 1959 and 1966, and followed for 60 years. CHDS monitors participants by annual linkage to the California Department of Motor Vehicles, the California Department of Vital Statistics and the California Cancer Registry.

Stillborn Birth Linked to Maternal SARS-CoV-2 Infection

NOV 15 2021

Clinicians in Ireland are warning about a spate of stillbirths in the first few months of 2021 that they have linked to SARS-CoV-2 infections. There were six women in the country who suffered stillbirths and one who experienced a miscarriage, each a few weeks after she had COVID-19. Five of the cases so far involved the variant B.1.1.7, which has now come to dominate cases in Ireland, the UK, much of Europe, and the US. In all instances, the placenta was extensively damaged. “The placentas look completely burnt out, just incredibly necrotic and damaged,” says Keelin O’Donoghue, an obstetrician at Cork University Maternal Hospital in Ireland who is part of team preparing a manuscript on the cases. “They all have suffered acute injury, which is why you have an acute effect in terms of fetal compromise or death.” In addition to the stillbirths and miscarriage, there have also been three instances so far this year in Ireland in which expectant mothers diagnosed with COVID-19 had emergency deliveries and severely degraded placentas. The babies survived. “There’s a very abnormal appearance” to the surface of the placenta when it is cut for examination, says Brendan Fitzgerald, a pathologist at Cork University Hospital who has examined five of the affected placentas, “with white streaks and nodules occupying large portions of the placental disk. It is a very uncommon finding that we would rarely see in routine practice.”

Masimo Launches Dual SET Pulse Oximetry

NOV 1 2021

Masimo announced Dual SET Pulse Oximetry for Root, a highly versatile patient monitoring and connectivity hub. The first application of Dual SET Oximetry is a significant advancement to Masimo SET-guided critical congenital heart disease (CCHD) screening, with the CE marking and European launch of the Masimo SET MOC-9 module and the addition of the Eve CCHD Newborn Screening Application for Root. Together, this combined solution enhances the automation of newborn screenings using Dual SET Oximetry: two simultaneous measurements of oxygen saturation (SpO2) at pre- and post-ductal sites by the intuitive Eve application, customized to align with a hospital’s CCHD screening protocol. CCHD affects approximately 2.5 to 3 newborns per 1000 live births and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage. Traditionally, newborns were observed for evidence of CCHD by physical assessment and monitoring for common symptoms, but studies have shown that physical assessment of newborns alone can be unreliable and may fail to detect some infants with CCHD before discharge. Adding screening with pulse oximetry can help clinicians identify CCHD before an infant becomes symptomatic. Clinically proven Masimo SET Measure-through Motion and Low Perfusion pulse oximetry has been shown in more than 10 CCHD screening studies – representing over 300,000 babies – to increase the effectiveness of screening newborns for CCHD. For example, in a study of almost 40,000 infants, CCHD screening sensitivity increased from 63% with physical exam alone to 83% with physical exam and SET. In another study of more than 120,000 infants – the largest CCHD screening study to date – combined use of clinical assessment and SET increased screening sensitivity from 77% to 93%. Evidence from CCHD studies using SET has even been used to help establish CCHD screening guidelines used around the world. Powered by Masimo SET pulse oximetry, the Eve CCHD Newborn Screening Application is designed to simplify the CCHD screening process by providing step-by-step visual instructions, animations, and a detailed, easy-to-interpret display of screening results – standardizing and enhancing clinical workflows, improving consistency in screening practices among clinicians, and reducing the possibility of calculation errors. Eve also allows clinicians to incorporate perfusion index into screening, which has been shown to increase sensitivity to the detection of CCHD. Already available for Radical-7 and Rad-97 Pulse CO-Oximeters, Eve is particularly well suited for display on Root’s large, high-resolution screen. With its built-in barcode scanner, Root can automatically associate patients with their screening results, and with its integration into the Masimo Hospital Automation platform, Root automates the transfer of those results to electronic medical records (EMRs) – eliminating the need for manual charting. Now, with the addition of the new Masimo SET MOC-9 module for Root – made possible by another key differentiator of the hub, its advanced, flexible connectivity capabilities – CCHD screening guided by Eve is even more streamlined and efficient: one pulse oximetry sensor can be connected to Root via Radical-7, and a second via the MOC-9 module, allowing for the pre- and post-ductal SpO2 readings needed for screening to be taken simultaneously rather than sequentially, with results conveniently displayed on one screen. This Dual SET Oximetry technique streamlines the CCHD screening process, improving clinical workflows. Gerard R. Martin, MD, C.R. Beyda Professor of Cardiology at Children’s National Hospital, said, “As an advocate for congenital heart disease efforts nationally and internationally, I believe Masimo SET pulse oximetry is an excellent tool for pulse oximetry CCHD screening. Having access to accurate simultaneous pre-ductal and post-ductal measurements helps simplify the process of screening and allows for rapid recognition of discrepancies, ultimately improving newborn care.” Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide centralized, multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with numerous measurements in addition to dual oximetry Masimo SET, such as advanced rainbow Pulse CO-Oximetry measurements, O3 regional oximetry, and SedLine brain function monitoring, for expanded visibility of patient status. Using Root in combination with the Hospital Automation platform, monitoring data from all connected devices can be automatically charted in EMRs. Augusto Sola, MD, Vice President of Medical Affairs at Masimo, commented, “As a neonatologist who has worked nationally and internationally in the early diagnosis and treatment of hypoxemic and hyperoxemic conditions that affect neonates in order to improve neonatal survival and quality of life for these fragile infants, I know that Masimo SET measure-through motion technology’s accuracy and reliability have not only enabled CCHD screening with pulse oximetry, but have helped dramatically reduce retinopathy of prematurity (ROP). SET provides reliable, high-quality monitoring to prevent serious long-term morbidities and is now the standard of care for CCHD newborn screenings and ROP. With the availability of the SET MOC-9 Module, clinicians can now obtain simultaneous, dual oximetry pre- and post- ductal measurements, using one display, and increase efficiency of CCHD newborn screenings with Root. Furthermore, the Eve application on Root is automated and therefore simplifies and systematizes the screening process. Millions of newborn babies and their families throughout the world will be greatly benefited by this unique solution.”

Advanced Hearing Protection for Neonatal Transport & MRI

OCT 21 2021

NEATCap Medical has developed innovative passive noise protection systems for premature infants in the NICU, Transport and MRI. Sound levels experienced by ill newborns during air and ground hospital transport can average over 80 dBA, with peak levels as high as 85-95 dBA, and sound levels within MRI are similarly high. Because such loud noise can elicit physiological instability in heart rate in neonates during ambulance transport and MRI examinations, it is important to reduce patient noise exposure in these environments. NEATCAP DREAMIES T-M offer a unique solution to this problem. DREAMIES T-M materials and design provide sound attenuation across the audible frequency range, including low-frequency sounds associated with the air and ground transport sound environments, and sounds within the magnetic resonance imaging (MRI) sound environment. Reduced exposure to noise increases the probability that the MR examination can be completed without sedation and with fewer motion artifacts. Features include transparent, low-profile, contoured, soft foam sealing ear cups; adjustable, soft, stabilizing headband to secure ear cups; easy-to-fit and remove with Velcro closure; no skin-contacting adhesives to irritate skin allows patient positioning within transport incubator and MRI head coil; compatible with transport and MR imaging protocols; single Patient Use; and range of sizes to fit the full range of neonatal patients from small premies to full-term infants.

New Ceiling Supply Units Add Flexibility in Hospitals

Sep 30 2021

Dräger’s new Ambia and Ponta ceiling supply systems offer hospitals substantial flexibility in creating customized workstations that supports specific clinical needs in the operating room (OR), intensive care unit (ICU) and neonatal intensive care unit (NICU). The ceiling supply systems provide the ability to mount medical equipment and accessories on all four sides of the frame rail. This optimizes space, and allows equipment and accessories to be placed exactly where they are needed. Free positioning of a mix of electrical and gas outlets on all panels make it possible to place more outlets on a media column or head. The result, Ambia helps streamline workflow with the goal of increasing the satisfaction and safety of staff and patients – now and in the future. And with coordinated frame color selections and drawer decor variants, Ambia and Ponta can be easily integrated into any room concept, creating a patient-friendly environment. In addition, lighting options featuring warm, glare-free light, along with the ability to select from a range of RGB colors, helping to contribute to a calming and soothing atmosphere. Ambia and Ponta feature intuitive user interfaces that support quick and easy operation. The arm brake handles feature touch-sensitive sensors that automatically release the brakes, allowing rapid positioning of the media heads or columns. The brake handle locations on the units can also be adapted to suit individual staff or workflow requirements for ideal ergonomics. The handles communicate using wireless technology, allowing them to be located almost anywhere on the system. For infection protection, rounded profiles and smooth materials that are compatible with a wide range of disinfection products help make the Ambia and Ponta easy and fast to clean and disinfect. A range of cable management options help eliminate cord clutter and assist with reducing exposed surface area and the accumulation of dirt. A touchless user control for operating ceiling and floor lights further supports infection prevention efforts. Dräger has more than 60 years of consulting experience in the design of medical workplaces, including the analysis of work processes and space requirements, consulting for optimized workflows and digitally supported room concept creation, and on-site equipment implementation.

COVID-19 Vaccines in Pregnancy May Protect Baby, Too

Sep 30 2021

Women who receive COVID-19 vaccines during pregnancy pass antibodies to their babies, which could protect newborns from the disease, research has shown. In a new study that examines umbilical cord blood from 36 deliveries, researchers provide additional evidence that vaccines – and not COVID-19 infections – elicited the antibodies detected in this cohort. Researchers with New York University Langone Health conducted a study that included pregnant women who had received at least one dose of an mRNA COVID-19 vaccine (Pfizer/BioNTech or Moderna). All neonates had antibodies to the spike protein at high titers, the researchers found. Unlike similar prior studies, the researchers also looked for antibodies to the nucleocapsid protein, which would have indicated the presence of antibodies from natural COVID-19 infection. They did not detect antibodies to the nucleocapsid protein, and the lack of these antibodies suggests that the antibodies to the spike protein resulted from vaccination and not from prior infection, the researchers said. The participants had a median time from completion of the vaccine series to delivery of 13 weeks. The study was published online in the American Journal of Obstetrics & Gynecology MFM. “The presence of these anti-spike antibodies in the cord blood should, at least in theory, offer these newborns some degree of protection,” said study investigator Ashley S. Roman, MD, director of the division of maternal-fetal medicine at NYU Langone Health. “While the primary rationale for vaccination during pregnancy is to keep moms healthy and keep moms out of the hospital, the outstanding question to us was whether there is any fetal or neonatal benefit conferred by receiving the vaccine during pregnancy.” Questions remain about the degree and durability of protection for newborns from these antibodies. An ongoing study, MOMI-VAX, aims to systematically measure antibody levels in mothers who receive COVID-19 vaccines during pregnancy and in their babies over time.

HPV Infection During Pregnancy Ups Risk for Premature Birth

Sep 30 2021

Persistent human papillomavirus (HPV) 16 and HPV 18 during a pregnancy may be associated with an increased risk of premature birth. Findings published online in JAMA Network Open found that 15.9% of individuals who had a persistent HPV 16 or 18 infection during the first and third trimesters of their pregnancy gave birth prematurely, compared with 5.6% of those who did not have an HPV infection at all. The findings prompted the question of “the pathophysiology of HPV in pregnancy and how the virus is affecting the placenta,” said Lisette Davidson Tanner, MD, MPH, FACOG, who was not involved in the study. Researchers said the findings are the first to show the association between preterm birth and HPV, which is an incurable virus that most sexually active individuals will get at some point in their lives, according to the Centers for Disease Control and Prevention. “The results of this study are very important in helping us understand the burden caused by HPV in pregnancy,” study author Helen Trottier, MSc, PhD, researcher at the Centre Hospitalier Universitaire Sainte-Justine, said in an interview. “We may have just pinpointed an important cause of preterm birth that has so far been unexplained.” Dr Trottier and colleagues examined data from 1,052 pregnant women from three university-affiliated health care centers in Montreal between Nov. 8, 2010, and Oct. 16, 2016. Only 5.6% of those who did not have an HPV infection had a premature birth, compared with 6.9% of those who tested positive for any HPV infection in the first trimester. When looking at the first trimester, researchers found 12% of those diagnosed with HPV 16 and 18 had a preterm birth, compared to 4.9% of those who had a high-risk HPV infection other than HPV 16/18. When looking at the third trimester, researchers found that 15.9% of those with HPV 16/18 had an increased risk of giving birth prematurely, compared to those who had other high-risk HPV infections. When researchers looked at the persistence of these HPV infections, they found that most HPV infections detected in the first trimester persist to the third trimester. The findings also revealed that persistent vaginal HPV 16/18 detection was significantly associated with all preterm births and spontaneous preterm births. This association was also found among those who had HPV infections detected in their placentas. Meanwhile, 5.8% of those who had an HPV infection only during the first trimester experienced a preterm birth.

Congenital Syphilis Still Diagnosed Beyond Neonatal Period in US

Sep 30 2021

The annual number of congenital syphilis cases reported to the U.S. Centers for Disease Control and Prevention surged 183% from 462 cases in 2014 to 1,306 cases in 2018, and too many of these cases are being missed at or before birth, researchers say. During the entire study period, a total of 3,834 infants were delivered with congenital syphilis, the study team reports in Pediatrics. Of these deliveries, 55.5% were liveborn and asymptomatic when syphilis was diagnosed, while 38.1% were liveborn and symptomatic, and 6.4% were stillborn. Over the study period, the proportion of infants diagnosed with congenital syphilis beyond the neonatal period declined from 5.9% to 2.9%. However, there were 67 cases of symptomatic infants diagnosed beyond the neonatal period. “This finding was concerning as infants who are diagnosed and treated later in life may develop long-term problems from congenital syphilis, which include intellectual disabilities, physical deformities, and deafness,” said lead study author Dr Anne Kimball of the Division of Sexually Transmitted Diseases Prevention at the CDC in Atlanta. “Congenital syphilis can be prevented by diagnosing and adequately treating maternal infection during pregnancy or prior to pregnancy,” Dr Kimball said by email. For this reason, the CDC recommends universal screening for syphilis early in pregnancy, with repeat screening at 28 weeks’ gestation and at delivery for pregnant people at increased risk for syphilis acquisition on the basis of individual risk factors or high community prevalence, Dr Kimball said. Maternal serological status should also be confirmed before mothers and infants are discharged from the hospital after labor and delivery, including confirmation that the mother received at least one syphilis test during pregnancy and again at delivery for mothers at increased risk, Dr Kimball said. Among the cases of congenital syphilis found after the neonatal period, the majority had physical examination findings (67%) or abnormal long-bone radiographs (69%) indicating congenital syphilis. Many of these infants (36%) also had reactive syphilis testing in the cerebrospinal fluid; cases had a median serum nontreponemal titer of 1:256. Cases diagnosed after the neonatal stage had a median age of 67 days, although the ages ranged from 29 to 249 days.

New Study Evaluates the Feasibility of Using Masimo EMMA Capnography on Mechanically Ventilated Neonates

Sep 27 2021

Masimo announced the findings of a study published in the European Journal of Pediatrics in which Dr. Masashi Hotta and colleagues at the Osaka Women’s and Children’s Hospital in Japan found that the Masimo EMMA Portable Capnograph “may be considered an effective monitoring device” for mechanically ventilated preterm infants (neonates). Noting the importance of maintaining an appropriate range of partial pressure of arterial carbon dioxide (PaCO2) in preterm infants, especially while undergoing mechanical ventilation in the neonatal intensive care unit (NICU), the researchers sought to evaluate whether noninvasively monitoring end-tidal carbon dioxide (EtCO2) with EMMA could help clinicians maintain neonatal PaCO2 in the delivery room. They chose EMMA not only because of its portability but because it offers a solution with a small dead space (1 mL). The researchers enrolled 40 neonates (gestational age of 26+0 to 31+6 weeks) who required intubation in the delivery room (the EMMA monitoring group) and compared their PaCO2 value, either at admission to the NICU or 2 hours after birth, with that of 43 infants who did not undergo EMMA monitoring (the historical control group). They defined “appropriate” PaCO2 as 35 – 60 mmHg, as measured using a blood gas analyzer. The researchers found that the proportion of infants with appropriate PaCO2 was greater in the EMMA group than in the control group (80% vs. 42%, p = 0.001). Stratified according to birth weight (< 1000 g vs. > 1000 g), they found that in smaller neonates, there was no significant difference in the proportion of infants with appropriate PaCO2 between groups, but in the larger cohort, the rate of appropriate PaCO2 was significantly higher in the EMMA group: 93% vs. 44%, p < 0.001. The study authors concluded that EMMA “facilitated the maintenance of an appropriate PaCO2 for mechanically ventilated pre-term infants, especially infants with birth weight ≥ 1000 g, in the delivery room.” They noted that the main strength of their study was that they “collected intervention data prospectively and showed the feasibility of using a portable capnometer during resuscitation of intubated preterm infants” – the first study of its kind. EMMA provides seamless mainstream capnography for patients of all ages in a compact, easily portable device. The instrument requires no routine calibration and minimal warm-up time, with accurate EtCO2 and respiration rate measurements and continuous EtCO2 waveforms displayed within 15 seconds.

Masimo CEO Joe Kiani Appointed to President’s Council of Advisors on Science and Technology

Sep 22 2021

Masimo announced that Founder, Chairman, and CEO Joe Kiani has been appointed by President Joe Biden to the President’s Council of Advisors on Science and Technology (PCAST). Since 1933, with the creation by President Franklin D. Roosevelt of a Science Advisory Board, each President has established an advisory committee of scientists, engineers, and health professionals. Created by Executive Order, President Biden’s PCAST will advise him on matters involving science, technology, education, and innovation policy. The Council also provides the President with scientific and technical information needed to inform public policy relating to the American economy, the American worker, national and homeland security, and more. In particular, President Biden has asked PCAST to consider such pressing topics as how the pandemic can inform public health needs and how scientific and technological breakthroughs can help address climate change. The 30 members of the Council, the most diverse in history, include distinguished individuals from sectors outside the Federal Government with diverse perspectives and expertise in science, technology, education, and innovation, including 20 elected members of the National Academies of Sciences, Engineering and Medicine, five MacArthur “Genius” Fellows, two former Cabinet secretaries, and two Nobel laureates. Joe Kiani commented, “Thank you, President Biden, for this appointment. I am excited to work with this incredible PCAST group and others to explore ways that science and technology, and policies that can shape them, can improve healthcare, the environment, innovation, and equity in our country and the world.”

Iron Deficiency in Pregnancy Is Common, yet Many Aren't Being Screened for It

Sep 15 2021

Many pregnant patients are not being screened for iron deficiency despite it being a common cause of anemia in pregnancy that could increase the risk of maternal and infant death. Researchers analyzed data from 44,552 pregnant patients in Ontario, Canada, collected between 2013 and 2018 to determine the prevalence of ferritin testing, the standard test for iron deficiency, over the course of 5 years. Their study, published in Blood Advances, revealed that only 59.4% of pregnant persons received a ferritin test, the standard test for iron deficiency. Of those pregnant persons, 25.2% were iron insufficient and 52.8% were iron deficient at least once during pregnancy. They also found that 71% of these iron tests were ordered during the first trimester, when the risk of iron deficiency is lowest. “We are not only missing a very large proportion of women who are iron deficient going into pregnancy, but we’re missing those that become iron deficient later on in their pregnancies,” study author Dr Jennifer Teichman, hematology resident at the University of Toronto, said in an interview. Researchers said iron deficiency during pregnancy is associated with maternal fatigue, cognitive dysfunction, depression, low birth weight, and poor brain development of the child. Teichman explained that if iron deficiency during pregnancy is identified early enough, doctors would have enough time to treat the condition with iron supplements before the patient goes into delivery. She also explained prenatal vitamins, which contain some iron, do not contain enough of the mineral to fix iron deficiency. “One really important point is that the amount of iron contained in a prenatal vitamin is really low,” Teichman explained. “It’s enough to make up the difference of the additional iron that she needs to sustain her pregnancy, but it’s not enough to treat a woman who’s already got low iron going into pregnancy. So there’s a difference between a prenatal vitamin and true iron supplementation.” Researchers also found that those who came from a household with a low annual income were even less likely to receive a ferritin test, which was a troubling finding since women of lower socioeconomic status are more likely to be iron deficient in pregnancy. “[This] says something about how we as health care providers are contributing to this gap in care,” Teichman said. “Women of lower socioeconomic status sort of have a triple whammy: They’re more likely to be iron deficient, they’re less likely to have it diagnosed, and they’re less likely to have it corrected.” Teichman and her colleagues took a unique approach by looking at isolated ferritin levels as opposed to complete blood counts, which is the typical screening for anemia in pregnancy, said Lissette Tanner, MD, MPH, FACOG, who was not involved with the study. “Those who meet the criteria for anemia should be evaluated for the cause with initial suspicion for iron deficiency anemia, as that is the most common etiology,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. The Centers for Disease Control and Prevention recommends screening for iron deficiency anemia in pregnant persons, in addition to universal iron supplementation to meet the iron requirements of pregnancy. Additionally, the American College of Obstetricians and Gynecologists recommends that all pregnant persons be screened for anemia with a complete blood count in the first trimester and again between 24 and 28 weeks of pregnancy. However, iron deficiency is completely missed by ACOG’s recommendations, said Michael Auerbach, MD, of the department of medicine, Georgetown University, Washington. “They recommend a [complete blood count] on all presenting pregnant women, but they do not recommend iron parameters, including a ferritin test, unless the mother is anemic,” said Auerbach, who was not involved in the study. “I think those guidelines are in need of revision.” Teichman hopes her team’s findings will motivate change in obstetric and hematologic guidelines that recommend routine prenatal testing. “I think ferritin should be a part of routine prenatal testing,” Teichman said. “And I also think that patients need to be empowered to ask what their iron levels are in pregnancy and providers need to know what a normal iron level is.”

Infants Breathe Better When Pregnant Moms Exercise

Sep 15 2021

Lung function in early infancy may be influenced by the mother's level of physical activity during pregnancy, results of a study from Sweden suggest. Low-lung function at 3 months of age, as measured by the ratio of time to peak tidal expiratory flow to expiratory time (tPTEF / tE), was more frequent among children whose mothers were physically inactive during the first half of pregnancy compared with those who exercised either moderately or strenuously, reported Hrefna Katrin Gudmundsdottir, MD, a pediatrician and PhD candidate at the University of Oslo, Norway. The results were based on a prospective observational study of 841 mother-child pairs. "The potential link between maternal inactivity and low lung function in infancy adds to the importance of advising pregnant women and women of childbearing age on physical activity," she said in an oral abstract presented during the virtual European Respiratory Society (ERS) International Congress. Jonathan Grigg, MD, professor of pediatric respiratory and environmental medicine at Queen Mary University of London, United Kingdom, who was not involved in the study, commented that it "offers a fascinating hint that increased physical activity of mothers is associated with better lung function in their babies and, therefore, possibly their health in later life. More research is needed to confirm this link, but it is important that women feel supported by their healthcare providers to be active in a way that is comfortable and accessible to them." Impaired lung function in infancy is associated with wheezing and asthma in childhood, and lower lung function later in life, Gudmundsdottir said. She also noted that impaired lung function begins in utero and is related to fetal and infant size, family history of asthma, and/or maternal smoking. Physical activity during pregnancy has been demonstrated to reduce the risk of preterm birth and cesarean birth, and to children being born either abnormally small or abnormally large for their gestational age, she explained. To see where physical inactivity in the first half of pregnancy is associated with lower lung function in otherwise healthy 3-month old infants, Gudmundsdottir and colleagues looked at data on a mother-child cohort from the prospective population-based PreventADALL study, which was designed to study prevention of atopic dermatitis and allergies in children in Norway and Sweden. A total of 814 infants (49% female) had available measures of tidal flow volume in the awake state at 3 months, as well as mother-reported data on physical activity at 18 weeks of pregnancy.

COVID-19 Disease May Actually Cause Preeclampsia, Suggests Study

Sep 15 2021

New evidence strongly suggests that COVID-19 disease causes an increased risk of preeclampsia and preterm birth in those who have an infection while pregnant, according to a retrospective observational study published in the American Journal of Obstetrics and Gynecology. Though the study was observational, its primary finding was a dose-response relationship between the severity of COVID-19 disease and the likelihood of preeclampsia or preterm birth, fulfilling a key criterion for establishing causality in an association. “The fact that 43% (13/30) of the cases of preeclampsia diagnosed after SARS-Cov-2 infection were preterm preeclampsia (< 37 weeks) suggests that COVID-19 may be a cause for medically indicated preterm birth that contributes to the excess preterm birth delivery rate previously reported,” wrote Jonathan Lai, MD, of the Fetal Medicine Research Institute of King’s College Hospital, London, and colleagues. The study also found an increased likelihood of COVID-19 disease in those who had preeclampsia before their infection. “Whether preeclampsia can predispose COVID-19 some cases, or that the two conditions may co-occur because they share similar risk factors requires further investigation,” the authors wrote. It’s also unclear whether the increased risk of pre-eclampsia is contributing to the higher preterm birth risk, according to Linda Eckert, MD, a professor of Ob.Gyn. at The University of Washington who specializes in maternal immunization. “COVID is linked to preeclampsia in this study, and COVID is linked to preterm birth,” Dr. Eckert said in an interview. “The question of whether preeclampsia leading to preterm birth is also linked to infection is not possible to tease out in this study as all the factors are likely interrelated. There is a relationship between COVID and preterm birth absent preeclampsia.” The researchers retrospectively examined data from 1,223 pregnant women who tested positive for SARS-CoV-2 between February 2020 and March 2021 at any of 14 National Health Service maternity hospitals in the United Kingdom. The researchers compared the severity of disease among the women with their risk of preeclampsia as a primary outcome, followed by the outcomes of preterm birth and gestational age at delivery. COVID-19 infections were classified as asymptomatic, mild illness (lacking shortness of breath, dyspnea, or abnormal chest imaging), moderate illness (evidence of lower respiratory disease but an oxygen saturation of at least 94%), and severe illness (requiring “high dependency or intensive care secondary to respiratory impairment/failure or multiorgan dysfunction”). The researchers adjusted their analysis of preeclampsia to account for prior risk of preeclampsia based on maternal characteristics and medical history. Analysis of preterm birth risk included adjustment for maternal age, weight, height, race, method of conception, chronic hypertension, smoking, and diabetes. Preeclampsia occurred in 4.2% of the women, and 17.6% of the women had a preterm birth. In addition, 1.3% of the cohort had a miscarriage, and there were 10 (0.81%) fetal deaths. Since 21 cases of preeclampsia occurred before the women tested positive, the researchers removed those cases from the analysis. Among the remaining 30 cases, 13 women had preterm preeclampsia and 17 had term preeclampsia. When the researchers compared the study population’s risk of preeclampsia with that of a separate population with similar risk factors, they found a dose-response increased risk in those with COVID-19 infections. While 1.9% of asymptomatic patients had preeclampsia, incidence was 2.2% in patients with mild disease, 5.7% in those with moderate disease, and 11.1% in those with severe disease. Women with severe COVID-19 tended to be older and to have a higher body mass index. After adjustments, women were nearly five times more likely to develop preeclampsia if they had severe COVID-19 compared to women with asymptomatic infection (adjusted relative risk [aRR] = 4.9). Those with moderate or severe disease had triple the risk of preeclampsia compared to those with mild or asymptomatic infection (aRR = 3.3).

Company Introduces Disposable Ear Coupler for Infants

Sep 1 2021

Sanibel Supply has introduced a new disposable ear coupler for auditory brainstem response (ABR) testing in infants: the EARturtle. Resembling a turtle shell in shape and form, the EARturtle is placed over the baby’s ear for non-intrusive ABR testing. The EARturtle is distributed by Hearing Screening Associates (HSA) in the US. The main benefit of the EARturtle is its flexibility, as it can be used with the RadioEar IP30 and Sanibel Supply EARturtle adapter and similar transducer couplers. Thus, it can be used with various equipment for ABR testing. Jakob Skovgaard, Business Unit Manager, Sanibel Supply, comments: “Our goal is to make it easy for users of diagnostic hearing equipment to acquire quality consumables. With the EARturtle, we offer a consumable that can help to make ABR newborn hearing screening a more widely adopted discipline, which is very important in our eyes.” Other benefits worth of note: 1) Safe to apply on sensitive skin. The EARturtle complies with ISO 10993-1:2018, ensuring it is safe to apply on the sensitive skin of babies. 2) Equivalent RETSPLs to other disposable ear couplers. The EARturtle RETSPL values are equivalent to the EarCup and other known disposable ear couplers. 3) Equivalent performance to other disposable ear couplers. The EARturtle has a relatively flat frequency response in the range from 350 Hz to 5.5 kHz, which is equivalent to the EarCup and other known disposable ear couplers.

Jury Out on PIGF Testing for Suspected Pre-eclampsia

Aug 30 2021

The addition of placental growth factor (PlGF) measurement to usual care of women with suspected preeclampsia does not improve maternal or neonatal outcomes, according to results of PARROT Ireland, the largest multicenter randomized controlled trial of PlGF-based testing for women with suspected preeclampsia to date. “Given the lack of maternal or neonatal clinical benefit demonstrated in our trial, we cannot endorse the use of PlGF testing as a diagnostic adjunct to clinical care in women with suspected preeclampsia at present and recommend further research be conducted,” researchers write in the BMJ. Cohort studies have suggested high sensitivity and high negative predictive value of PlGF testing in gauging the need for early delivery in women with suspected preeclampsia. However, there is concern that integrating PlGF testing into routine clinical care may lead to an earlier intervention, lowering gestational age at delivery and increasing problems in newborns. The PARROT Ireland study, conducted at seven maternity hospitals, enrolled women with a singleton pregnancy between 20 and 36 weeks’ gestation and with signs or symptoms suggestive of evolving preeclampsia. The primary analysis - based on 1,202 women randomly allocated to usual care alone and 1,017 to usual care plus point-of-care PlGF testing - showed no significant difference in maternal or neonatal morbidity with the integration of point-of-care PlGF testing. “The PARROT Ireland trial shows that integrating a PlGF test into routine investigations for women presenting <37 weeks with a singleton pregnancy and signs/symptoms of evolving preeclampsia did not improve or worsen outcomes for women or their babies,” lead author Dr Deirdre Hayes-Ryan of INFANT Research Centre UCC, Cork University Maternity Hospital, told Reuters Health by email. “The results add to the information available currently on the impact of PlGF as an interventional test and do not support the use of PlGF testing as a diagnostic adjunct in women with suspected preeclampsia,” Dr Hayes-Ryan said. “Given the imminent assessment of PlGF testing by the National Institute for Health and Care Excellence (NICE), we recommend urgent reappraisal of the evidence and postponement of updating of guidelines on PlGF testing until an individual participant data (IPD) meta-analysis is performed,” the researchers advise in their paper. “An IPD meta-analysis of participants from both the UK and Irish PARROT trials is feasible, given both trials employed the same online electronic clinical report form templates and collected the same data points,” they add. Dr Hayes-Ryan said NICE has contacted them in relation to the trial results, and it is her understanding that they are currently performing an appraisal of all available research.

Preterm and Early Term Birth Linked to Increased Autism Rise

Aug 30 2021

Preterm and early term birth were associated with a significantly increased risk for autism spectrum disorder in both boys and girls in a study that included more than 4 million children born over a 40-year period in Sweden. According to the study, which was published in Pediatrics, the prevalence of ASD was 2.1% for all preterm births, 1.6% for early term births and in 1.4% for term births. In a related editorial, Elisabeth C. McGowan, MD, and Stephen J. Sheinkopf, PhD, both associate professors of pediatrics at Brown University, said the findings were consistent with previous research “suggesting a dose response-type relationship between degree of prematurity and ASD risk.” They called the new study “in many ways a definitive accounting of the elevated rates of ASD in preterm infants.” “And although the impact of prematurity on brain development may be part of the causal chain resulting in ASD (or other neurodevelopmental outcomes), these factors are operating in a complex biological landscape, with pathways to ASD outcomes that can be expected to be heterogeneous,” they wrote. For the study, Casey Crump, MD, PhD, vice chair for research in the department of family medicine and community health at the Icahn School of Medicine at Mount Sinai in New York, and colleagues included 4,061,795 singleton infants born in Sweden from 1973 through 2013 who survived to the age of 1 year, were followed up for ASD and were diagnosed by 2015. They categorized participants by gestational age at birth: extremely preterm (22 to 27 weeks), very to moderate preterm (28 to 33 weeks), late preterm (34 to 36 weeks), early term (37 to 38 weeks), term (39 to 41 weeks) and post term (at or more than 42 weeks). The first three groups were combined for summary estimates of preterm births (at or less than 37 weeks). The prevalence ratios, when adjusted for covariates, were significantly elevated among extremely preterm (3.87; 95% CI, 3.48-4.31), all preterm (1.40; 95% CI, 1.36-1.45) and early term births (1.12; 95% CI, 1.10-1.14), Crump and colleagues reported. According to the authors, an estimated 83.7% of ASD cases among participants born extremely preterm, 37.7% of cases among those born any preterm and 18.9% of cases among those born early term were attributed to gestational age at birth. “In this large population-based cohort, preterm and early term birth were associated with significantly increased risks of ASD in boys and girls,” Crum and colleagues wrote. “These findings were largely independent of measured covariates and unmeasured shared familial factors, consistent with a potential causal relationship.” McGowan and Sheinkopf said other investigations have shown “higher incidences of early cognitive, language motor and impairment, and school problems, social-emotional problems, and psychiatric disorders, some of which may extend to adulthood,” among late preterm infants. They said, “careful attention should be paid to biological vulnerabilities at later gestational ages.” “For example, between 34 and 40 weeks, brain weight increases nearly one-third, cortical volume increases nearly 50%, and absolute myelinated white matter volume increases fivefold,” they wrote.

AHA Targets Rising Prevalence of Obstructive Sleep Apnea in Children

Aug 30 2021

Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association. The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese. The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association. Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented. “There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.” For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.” The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring. In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.” Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote. Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.

Product to Secure Endotracheal Tubes Now on Sale

Aug 25 2021

B&B Medical Technologies announced that Baby Tape Plus is available for immediate sale. The product is used to secure endotracheal tubes for neonatal patients, is an FDA listed Class I device and carries the CE mark. B&B Medical has come to be known as a manufacturer that provides unique solutions for the NICU since the introduction of their infant water seal CPAP valve, the B&B Bubbler, in 2014. “Being one of the pre-eminent manufacturers of endotracheal tube security products and bubble CPAP components gave us special insight into a need that the market was requesting”, said Allyn Wilkes, Acute Care Account Representative at B&B Medical. “The clinician/patient field testing we conducted assisted us in designing a cost-effective product with the performance and reliability that our customers expect from B&B Medical’s endotracheal tube security products”. Baby Tape Plus is a pre-cut endotracheal tube holder made from a non-irritating, latex free hydrocolloid adhesive that is skin friendly for infants. Like all B&B Medical endotracheal tube holders, Baby Tape Plus is designed to be quick and simple to use in a wide variety of situations. The circular tube wrap makes for a cleaner, easier application and the larger wing tabs cover a bigger surface area for greater security, they can also be trimmed to fit a wide range of infants. In addition, the securing neonatal ET Tubes the middle tape strips can also be used to secure nasogastric/orogastric tubes and cannulas. “We’ve had numerous requests from all over the globe to add a solution for babies to our line of endotracheal tube security products” said Stu Novitz, VP of Sales and Marketing at B&B Medical. “We believe the addition of Baby Tape Plus will further establish B&B Medical as a leader in the neonatal and endotracheal tube security markets.” B&B Medical Technologies’ goal is to develop innovative products that deliver positive outcomes, provide good patient care while addressing the need to control healthcare costs. We pride ourselves on developing products that support the patient and clinician’s need throughout the continuum of care.

World’s Smallest Baby at Birth Released from Hospital

Aug 10 2021

A baby thought to be the world's smallest at birth—weighing around the same as a large apple when she was delivered—was discharged from hospital after more than a year of treatment. Kwek Yu Xuan was born on June 9, 2020, at Singapore's National University Hospital (NUH,) just under 25 weeks into the pregnancy term. Pregnancy usually lasts for around 40 weeks. At birth, Yu Xuan weighed just 212 grams (7.47 ounces) and measured 24 centimeters (9.4 inches) long, according to the hospital. Delivered via emergency caesarean section, Yu Xuan is likely to be the lightest baby to survive a premature birth. According to the Tiniest Babies Registry managed by the University of Iowa, the previous smallest survivor was a baby girl born in the U.S. in May, 2019, who weighed 245 grams at birth. The NUH announced that the baby had been "discharged home well" in a Facebook post. "We are happy for the little fighter and her family, and proud of the care provided by our team," the post said. "Our best wishes to Little Yu Xuan as she continues to grow, thrive and beat the odds every day." The hospital said in a statement that Yu Xuan had grown to around 6.3 kilograms (13.8 pounds) and is progressing well. The 14-month-old infant has chronic lung disease and pulmonary hypertension—two conditions that are often associated with extreme prematurity—and has to be on a ventilator at home, although the hospital said she is expected to get better with time. Born in the midst of the global pandemic, the hospital said she had a "limited chance of survival" due to her extremely premature birth. "Against the odds, with health complications present at birth, she has inspired people around her with her perseverance and growth, which makes her an extraordinary 'COVID-19' baby—a ray of hope amid turmoil," the NUH said in the statement. Yu Xuan's mother was forced to undergo an emergency caesarean section at 24 weeks and six days of gestation due to preeclampsia—dangerously high blood pressure during pregnancy that in rare cases can be fatal.

Women's Heart Health Tied to Multiple Pregnancy Complications

Jul 27 2021

Women with prepregnancy cardiovascular disease (CVD) risk factors have increasingly worse pregnancy outcomes, including a higher rate of maternal intensive care unit (ICU) admissions and fetal deaths, a new study suggests. "With every additive cardiovascular risk factor — and it didn't matter which risk factor — there was a graded and consistently higher risk for each of the pregnancy complications," senior author Sadiya Khan, MD, Northwestern University Feinberg School of Medicine in Chicago, said in an interview. Previous studies have shown that the presence of individual risk factors such as obesity and hypertension before pregnancy are associated with worse maternal and neonatal outcomes. Identifying the association with the total burden of prepregnancy CVD risk factors, however, may help guide comprehensive prevention strategies that look beyond targeting any one risk factor, the authors note. The results were published online July 20 in the European Journal of Preventive Cardiology. The researchers analyzed 18,646,512 pregnancies using maternal and fetal data drawn from the US National Center for Health Statistics and pooled individual-level data from births to women aged 15-44 years (mean, 28.6 years) from 2014 to 2018. Women were categorized on the basis of having 0 to 4 prepregnancy CVD risk factors: hypertension, diabetes, self-reported smoking, and a BMI less than 18.5 kg/m2 or greater than 24.9 kg/m2. All analyses were adjusted for maternal age at delivery, race/ethnicity, education, receipt of prenatal care, parity, and birth plurality. Over 60% of the women had one or more CVD risk factors, with 52.5% having one, 7.3% two, 0.3% three, and 0.02% four.

Hematologic Cancer Increases Risk for Delivery Complications

Jul 27 2021

The risk of in-hospital complications and poor birth outcomes were greater in pregnant women with current or historical cancer diagnoses, new research suggests. The study, published in Mayo Clinic Proceedings, found that women with current and historical cancer diagnoses had an increased risk of death, kidney injury, and stroke during delivery hospitalizations, compared with those with no cancer. When it came to delivery outcomes, this group also had a higher risk for preterm birth and postpartum hemorrhage. Those with a current cancer diagnoses had a 1.7-fold increase in odds for a preterm birth, compared with women without cancer. “Our study found that metastases increased the odds of mortality, cesarean delivery, preterm birth, and stillbirth,” the researchers noted. “Coupled with previous research reporting that pregnant women are more likely to be diagnosed with advanced disease, this implies that pregnant women with newly diagnosed cancer have poor prognoses.” However, although women with prior cancer had increased odds of mortality, the researchers said it was not statistically significant. “The study really did not show an increase of mortality [for women with prior cancer diagnosis],” said Justin Chura, MD, a specialist in gynecologic oncology who was not involved in the study. “And the reason might be because there is not or the reason might be because it’s such a rare event. You would need 100 million births to assess that. So I would actually use caution in that interpretation.” Researchers analyzed more than 43 million delivery hospitalizations of women with or without current or historical cancer diagnoses between January 2004 and December 2014. They found that the most common cancer diagnoses were hematologic, thyroid, cervical, skin, and breast. Of the five most common cancers, the prevalence of all maternal complications and negative delivery outcomes was the highest among women with hematologic cancers. They were more likely to experience peripartum cardiomyopathy, acute kidney injury, and arrhythmia, compared with other cancers. Postpartum hemorrhage, maternal mortality, and placental abruption was also more likely to occur in those with this type of cancer. “I was surprised that it was the hematologic cancers that were worse when they did it by cancer type,” said Dr Chura, who is the chief of surgery and the director of gynecologic oncology and robotic surgery at the Cancer Treatment Centers of America’s Eastern Regional Medical Center in Philadelphia. “I think this is a useful bit of information for counseling our patients and also to identify the cohort with the highest risk.” The findings also suggested that those with skin cancer had the highest odds for stroke, while women with cervical and breast cancers were more likely to experience acute kidney injury and preterm birth. Dr Chura said cancer treatments can have an impact on a woman’s health when she’s giving birth. For example, if a woman is diagnosed with cervical cancer, doctors may perform a cone biopsy on her where they remove a large portion of the cervix and still leave them with the ability to conceive and become pregnant. However, those patients are left with a higher risk of a preterm delivery. For women with a hematologic cancer like non-Hodgkin’s lymphoma, chest radiation may cause some subsequent damage to their heart muscles “and now the stress of pregnancy puts more demand on the heart that can lead to cardiac complications for that patient,” Dr Chura said. “There are potential long-term effects from radiation and chemotherapy,” Dr Chura said. Previous studies have shown that chemotherapy may affect pregnancy and delivery. A 2019 study published in the Journal of Cancer also found that 59 pregnant women with cancer had increased mortality compared with those without the long-term illness. Meanwhile, another 2018 study published in Cancer found that women who conceived less than a year after starting chemotherapy had higher risks of preterm birth in comparison with those who conceived more than a year after starting chemotherapy. The study also found that cancer survivors who conceived more than a year after finishing chemotherapy with or without radiation had no higher risk of a preterm birth than those without cancer. Dr Chura said the new study could force doctors to think about the long-term effects of their cancer therapies and make them more apt to think about how to make cancer therapy less toxic with less long-term health consequences, while still curing patients. “Most oncologists, when dealing with younger patients, are very focused on curing the cancer at hand, but not necessarily thinking 5 or 10 years down the road,” Dr Chura said. “[This study] could help inform or at least make us aware of the long-term consequences of our cancer therapies.”

Systemic and Structural Racism Present in U.S. Neonatal Intensive-care Units

Jul 27 2021

Quality of care across and within neonatal intensive-care units (NICUs) in the United States varies by race and ethnicity, according to a new study that points to systemic and structural racism starting at birth. This study highlights "many important quality gaps that raise unanswered questions about the relationships between race and ethnicity and processes and outcomes of care," the study team says in their paper. "Ultimately, until neonatal and pediatric clinicians and providers accept that they must practice social as well as technical medicine and follow through to address social determinants of health and act against racism, we will not achieve comparable high-quality care for all infants," they add. For their study, Dr Erika Edwards of the Vermont Oxford Network and the University of Vermont, in Burlington, and colleagues used Baby-MONITOR, a summary quality measure for NICUs. This tool includes nine elements including five process measures (any human milk at discharge, no admission hypothermia, antenatal steroid exposure, no healthcare-associated infection, and timely retinal examination) and four outcome measures (survival to hospital discharge, no chronic lung disease, no pneumothorax, and greater than median growth velocity). A higher Baby-MONITOR score indicates a higher quality of care. The prospective cohort study included 169,400 infants born between 25 to 29 weeks' gestation or with a birth weight of 401 to 1,500 grams at 737 US hospitals. When compared with non-Hispanic white infants, African American and American Indian infants had significantly lower (worse) process scores on discharge on human milk, no admission hypothermia, and antenatal steroid exposure. And African American, Hispanic, Asian American and American Indian infants had higher (better) outcome scores on survival to hospital discharge, no chronic lung disease, and no pneumothorax, the authors report. "An increased risk for preterm birth, receipt of lower quality care, and socioeconomic disadvantages over of the life course are all markers of the structural and systemic racism found in the United States," they point out. "Even within the same hospitals, African American infants received lower average scores on important markers of quality of care, such as the receipt of antenatal steroids and having no hypothermia on admission. We also found that the geographical location of hospitals continues to play a role in determining the quality of care by race and ethnicity," they note. To their knowledge, this is the first study to use Baby-MONITOR to evaluate the quality of care for American Indians and these infants had lower average process score and higher average outcome score, compared with that of white infants. "American Indian mothers have the second highest rates of preterm birth behind non-Hispanic African American mothers. Addressing the quality of care that Native Americans receive deserves further attention with consideration of the context of the specific perinatal risk factors that American Indian women face," Dr Edwards and colleagues suggest in their paper.

Texas Hospital Delivers 107 Babies in 91 Hours

Jul 15 2021

A Texas hospital set a record at the end of June when staff delivered more than 100 babies in 91 hours, according to a local report. The deliveries occurred across two 48-hour stretches at Andrew Women’s Hospital at Baylor Scott & White All Saints Medical Center in Fort Worth, according to WFAA 8, an ABC affiliate in Dallas. On June 24, staff delivered 25 girls and 27 boys in 47 hours. On June 28, staff delivered 55 babies, including a set of twin girls, in 44 hours. “It’s been all fireworks as our Labor and Delivery teams … have been busy delivering an adorable group of Fourth of July babies —107 of them in just 91 hours to be exact!” the hospital said in a Facebook post. The stretch of deliveries broke the hospital’s record from June 2018, WFAA 8 reported. The hospital averages about 16 deliveries per day and last year delivered 6,000 babies, including 100 sets of twins and two sets of triplets. Six of the baby girls were named Gianna, the news outlet reported. Other popular names included Reign for girls and Atlas and Daniel for boys. The staff expected to see an uptick in births this year as people recover from the pandemic, but the June influx was rare and exceptional, according to NBC 5. “We thought it was going to be higher the last few months because of the pandemic, but didn’t see the baby boom until now, so people must’ve gotten more reassured,” Jay Herd, MD, an obstetrician at the hospital, told the news outlet. The hospital’s labor and delivery teams create photo galleries of babies who are born around the holidays. The Tiniest Texans series features portraits of the newborns, often dressed in holiday-themed clothes.

Fewer Preterm Infants in US Getting Mechanical Ventilation

Jul 15 2021

The duration of respiratory support for preterm infants in the US has increased in recent years as the reliance on mechanical ventilation has declined and use of noninvasive ventilation has become more common, a new study suggests. Researchers examined data on preterm infants from a clinical cohort of 259,311 infants in the Pediatrix Clincal Data Warehouse as well as a national cohort of 1.17 million infants in the National Inpatient Sample. All the preterm infants were born before 35 weeks gestation and received care on neonatal intensive care units between 2008 and 2018. From 2008 to 2018, the proportion of neonates in the clinical cohort receiving mechanical ventilation declined from 29.4% to 18.5% and the proportion receiving noninvasive ventilation climbed from 57.9% to 67.4%. Over this same period, the mean number of days on respiratory support increased from 13.8 to 14.4, driven in large part by more widespread use of continuous positive airway pressure and nasal intermittent positive pressure ventilation, the study team reports in JAMA Pediatrics. "While our study couldn't provide the exact reason why mechanical ventilation was decreasing, the decline in mechanical ventilation use seemed to begin at about the same time one of the largest clinical trials evaluating continuous positive airway pressure (CPAP) as the primary respiratory support in preterm infants was released," said Dr Dupree Hatch, an assistant professor of pediatrics and medical director of the NICU at Vanderbilt University Medical Center in Nashville, Tennessee, who led the current study.

"This study, the SUPPORT trial, along with several other studies released about the same time caused many of us in neonatal medicine to reconsider our approach to respiratory support in preterm infants," Dr Hatch said by email. Over the study period, the mean duration of mechanical ventilation declined from 10.3 days to 9.7 days among infants who received this type of respiratory support. During the same period, the mean duration of noninvasive ventilation increased by 3.2 days among infants receiving this type of support. In the national cohort analysis, researchers also found evidence of reduced use of mechanical ventilation. The proportion of preterm infants receiving this form of respiratory support declined from 22.0% to 18.5% during the study period. One limitation of the analysis is that researchers were unable to link the two data sets, making it possible that the populations in the two cohorts might not be entirely comparable, the authors note. Changes in transfer patterns during the study period also could have influenced the outcomes. Even so, the results underscore the importance of clinicians keeping up to date on the literature around respiratory support and carefully considering how trial outcomes might be relevant in the treatment of individual patients, said Dr Sara DeMauro, associate director of neonatal clinical and epidemiological research at the Children's Hospital of Philadelphia, who coauthored an editorial accompanying the study. "Mechanical ventilation usage is declining because neonatologists are concerned that exposure to mechanical ventilation is injurious, particularly to the preterm/immature lung," Dr DeMauro said by email.

Out-of-Pocket Costs for Childbirth More Than $3000

Jul 15 2021

Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes. The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues. “Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics. “Previous studies assessing this burden have focused on out-of-pocket spending for maternal care, including hospitalizations for delivery. However, there are no recent national data on out-of-pocket spending across the childbirth episode, including both deliveries and newborn hospitalizations.” To address this knowledge gap, Dr Chua and colleagues turned to Optum’s deidentified Clinformatics Data Mart, comprising 12 million privately insured individuals across the United States. The investigators identified 398,410 childbirth episodes occurring between 2016 and 2019. Each episode was defined as one delivery and at least one newborn hospitalization under the same family plan. Out-of-pocket cost included copayment plus coinsurance and deductibles. Primary outcomes included mean total out-of-pocket spending and proportion of episodes exceeding $5,000 or $10,000. Subgroup analyses compared differences in spending between episodes involving neonatal intensive care or cesarean birth. The mean out-of-pocket spending was $2,281 for delivery and $788 for newborn hospitalization, giving a total of $3,068 per childbirth episode. Coinsurance and deductibles accounted for much of that cost, at 55.8% and 42.1%, respectively, whereas copayments accounted for a relatively minor portion (2.2%). Almost all episodes (95%) cost more than zero dollars, while 17.1% cost more than $5,000 and 1.0% cost more than $10,000. Total mean out-of-pocket spending was higher for episodes involving cesarean birth ($3,389) or neonatal intensive care ($4,969), the latter of which cost more than $10,000 in 8.8% of episodes. “Because details on plan benefit design were unavailable, the generalizability of findings to all privately insured Americans is unclear,” the investigators noted. “However, the proportion of childbirth episodes covered by high-deductible health plans in this study is consistent with the prevalence of such plans among Americans with employer-sponsored insurance.” The findings suggest that financial reform is needed, Dr Chua and colleagues concluded. “To avoid imposing undue financial burden on families, private insurers should improve childbirth coverage,” they wrote. “An incremental step would be providing first-dollar coverage of deliveries and newborn hospitalizations before deductibles are met. Ideally, however, insurers would waive most or all cost-sharing for these hospitalizations, consistent with the approach taken by Medicaid programs and many developed countries.”

Probiotic Supplementation Regulates Newborn Immune System

Jul 15 2021

Supplementing breastfed infants with bifidobacteria promotes development of a well-regulated immune system, theoretically reducing risk of immune-mediated conditions like allergies and asthma, according to investigators. These findings support the importance of early gut colonization with beneficial microbes, an event that may affect the immune system throughout life, reported lead author Bethany M. Henrick, PhD, director of immunology and diagnostics at Evolve Biosystems, Davis, Calif., and adjunct assistant professor at the University of Nebraska, Lincoln, and colleagues. “Dysbiosis of the infant gut microbiome is common in modern societies and a likely contributing factor to the increased incidences of immune-mediated disorders,” the investigators wrote in Cell. “Therefore, there is great interest in identifying microbial factors that can support healthier immune system imprinting and hopefully prevent cases of allergy, autoimmunity, and possibly other conditions involving the immune system.” Prevailing theory suggests that the rising incidence of neonatal intestinal dysbiosis – which is typical in developed countries – may be caused by a variety of factors, including cesarean sections; modern hygiene practices; antibiotics, antiseptics, and other medications; diets high in fat and sugar; and infant formula. According to Dr Henrick and colleagues, a healthy gut microbiome plays the greatest role in immunological development during the first 3 months post-partum; specifically, a lack of bifidobacteria during this time has been linked with increased risks of autoimmunity and enteric inflammation, although underlying immune mechanisms remain unclear. Bifidobacteria also exemplify the symbiotic relationship between mothers, babies, and beneficial microbes. The investigators pointed out that breast milk contains human milk oligosaccharides (HMOs), which humans cannot digest, but are an excellent source of energy for bifidobacteria and other beneficial microbes, giving them a “selective nutritional advantage.” Bifidobacteria should therefore be common residents within the infant gut, but this is often not now the case, leading Dr Henrick and colleagues to zero in on the microbe, in hopes of determining the exactly how beneficial bacteria shape immune development. It is only recently that the necessary knowledge and techniques to perform studies like this one have become available, the investigators wrote, noting a better understanding of cell-regulatory relationships, advances in immune profiling at the systems level, and new technology that allows for profiling small-volume samples from infants. The present study involved a series of observational experiments and a small interventional trial. First, the investigators conducted a wide array of blood- and fecal-based longitudinal analyses from 208 infants in Sweden to characterize immune cell expansion and microbiome colonization of the gut, with a focus on bifidobacteria. Their results showed that infants lacking bifidobacteria, and HMO-utilization genes (which are expressed by bifidobacteria and other beneficial microbes), had higher levels of systemic inflammation, including increased T helper 2 (Th2) and Th17 responses. “Infants not colonized by Bifidobacteriaceae or in cases where these microbes fail to expand during the first months of life there is evidence of systemic and intestinal inflammation, increased frequencies of activated immune cells, and reduced levels of regulatory cells indicative of systemic immune dysregulation,” the investigators wrote. The interventional part of the study involved 60 breastfed infants in California. Twenty-nine of the newborns were given 1.8 x 1010 colony-forming units (CFUs) of B. longum subsp. infantis EVC001 daily from postnatal day 7 to day 28, while the remaining 31 infants were given no supplementation. Fecal samples were collected on day 6 and day 60. At day 60, supplemented infants had high levels of HMO-utilization genes, plus significantly greater alpha diversity (P = .0001; Wilcoxon), compared with controls. Infants receiving EVC001 also had less inflammatory fecal cytokines, suggesting that microbes expressing HMO-utilization genes cause a shift away from proinflammatory Th2 and Th17 responses, and toward Th1.

Company Signs Agreement with University

JUL 6 2021

Neotech Products has entered into a mutually beneficial agreement with Wichita State University. This exciting collaboration will provide Neotech with the resources of an institution well known for advanced research, including clinical work through their partners. Wichita State, a national leader in aerospace research, will benefit from the experience of a well-established and innovative medical device company as it expands research in the area of medical products. They will work closely with Neotech’s new product development team to explore product ideas that will impact the end user. “Wichita State is committed to using our aviation expertise for expanding research in other industries,” said Rick Muma, President of Wichita State University. “As a clinician in internal medicine and infectious diseases and a public health practitioner, I understand the need to continually innovate through collaboration in the healthcare sector. Partnerships with companies like Neotech Products do just that.” With this partnership, Neotech will have access to advanced facilities and technologies, including: Labs for materials and adhesive testing and research; Electron microscopes; CT scanning (for materials); Pull and compression testing; A wide array of 3D printing and scanning; VR visual design space. The partnerships’ first collaboration is a locking mechanism for the NeoBar ET Tube Holder. The idea originated with Dr Mohammed Ansari, a neonatologist with ties to the Wichita area. Wichita State teamed up with Dr Ansari and brought the idea to Neotech to drive the project forward. We’re extremely excited to see where it leads. Overall, the purpose of the partnership between Neotech and Wichita State is to utilize the combined expertise of both institutions to bring medical products to market that will truly make a difference.

Out-of-Pocket Costs for Childbirth More Than $3000

JUN 30 2021

Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes. The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues. “Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics. “Previous studies assessing this burden have focused on out-of-pocket spending for maternal care, including hospitalizations for delivery. However, there are no recent national data on out-of-pocket spending across the childbirth episode, including both deliveries and newborn hospitalizations.” To address this knowledge gap, Dr Chua and colleagues turned to Optum’s deidentified Clinformatics Data Mart, comprising 12 million privately insured individuals across the United States. The investigators identified 398,410 childbirth episodes occurring between 2016 and 2019. Each episode was defined as one delivery and at least one newborn hospitalization under the same family plan. Out-of-pocket cost included copayment plus coinsurance and deductibles. Primary outcomes included mean total out-of-pocket spending and proportion of episodes exceeding $5,000 or $10,000. Subgroup analyses compared differences in spending between episodes involving neonatal intensive care or cesarean birth. The mean out-of-pocket spending was $2,281 for delivery and $788 for newborn hospitalization, giving a total of $3,068 per childbirth episode. Coinsurance and deductibles accounted for much of that cost, at 55.8% and 42.1%, respectively, whereas copayments accounted for a relatively minor portion (2.2%). Almost all episodes (95%) cost more than zero dollars, while 17.1% cost more than $5,000 and 1.0% cost more than $10,000. Total mean out-of-pocket spending was higher for episodes involving cesarean birth ($3,389) or neonatal intensive care ($4,969), the latter of which cost more than $10,000 in 8.8% of episodes. “Because details on plan benefit design were unavailable, the generalizability of findings to all privately insured Americans is unclear,” the investigators noted. “However, the proportion of childbirth episodes covered by high-deductible health plans in this study is consistent with the prevalence of such plans among Americans with employer-sponsored insurance.” The findings suggest that financial reform is needed, Dr. Chua and colleagues concluded. “To avoid imposing undue financial burden on families, private insurers should improve childbirth coverage,” they wrote. “An incremental step would be providing first-dollar coverage of deliveries and newborn hospitalizations before deductibles are met. Ideally, however, insurers would waive most or all cost-sharing for these hospitalizations, consistent with the approach taken by Medicaid programs and many developed countries.”

VProbiotic Supplementation Regulates Newborn Immune System

JUN 30 2021

Supplementing breastfed infants with bifidobacteria promotes development of a well-regulated immune system, theoretically reducing risk of immune-mediated conditions like allergies and asthma, according to investigators. These findings support the importance of early gut colonization with beneficial microbes, an event that may affect the immune system throughout life, reported lead author Bethany M. Henrick, PhD, director of immunology and diagnostics at Evolve Biosystems, Davis, Calif., and adjunct assistant professor at the University of Nebraska, Lincoln, and colleagues. “Dysbiosis of the infant gut microbiome is common in modern societies and a likely contributing factor to the increased incidences of immune-mediated disorders,” the investigators wrote in Cell. “Therefore, there is great interest in identifying microbial factors that can support healthier immune system imprinting and hopefully prevent cases of allergy, autoimmunity, and possibly other conditions involving the immune system.” Prevailing theory suggests that the rising incidence of neonatal intestinal dysbiosis – which is typical in developed countries – may be caused by a variety of factors, including cesarean sections; modern hygiene practices; antibiotics, antiseptics, and other medications; diets high in fat and sugar; and infant formula. According to Dr Henrick and colleagues, a healthy gut microbiome plays the greatest role in immunological development during the first 3 months post partum; specifically, a lack of bifidobacteria during this time has been linked with increased risks of autoimmunity and enteric inflammation, although underlying immune mechanisms remain unclear. Bifidobacteria also exemplify the symbiotic relationship between mothers, babies, and beneficial microbes. The investigators pointed out that breast milk contains human milk oligosaccharides (HMOs), which humans cannot digest, but are an excellent source of energy for bifidobacteria and other beneficial microbes, giving them a “selective nutritional advantage.” Bifidobacteria should therefore be common residents within the infant gut, but this is often not now the case, leading Dr Henrick and colleagues to zero in on the microbe, in hopes of determining the exactly how beneficial bacteria shape immune development. It is only recently that the necessary knowledge and techniques to perform studies like this one have become available, the investigators wrote, noting a better understanding of cell-regulatory relationships, advances in immune profiling at the systems level, and new technology that allows for profiling small-volume samples from infants. The present study involved a series of observational experiments and a small interventional trial. First, the investigators conducted a wide array of blood- and fecal-based longitudinal analyses from 208 infants in Sweden to characterize immune cell expansion and microbiome colonization of the gut, with a focus on bifidobacteria. Their results showed that infants lacking bifidobacteria, and HMO-utilization genes (which are expressed by bifidobacteria and other beneficial microbes), had higher levels of systemic inflammation, including increased T helper 2 (Th2) and Th17 responses. “Infants not colonized by Bifidobacteriaceae or in cases where these microbes fail to expand during the first months of life there is evidence of systemic and intestinal inflammation, increased frequencies of activated immune cells, and reduced levels of regulatory cells indicative of systemic immune dysregulation,” the investigators wrote. The interventional part of the study involved 60 breastfed infants in California. Twenty-nine of the newborns were given 1.8 x 1010 colony-forming units (CFUs) of B. longum subsp. infantis EVC001 daily from postnatal day 7 to day 28, while the remaining 31 infants were given no supplementation.

Vaping and Pregnancy: Inhaled Toxins Among Reasons for Pause

JUN 30 2021

Researchers are trying to understand how e-cigarette use affects pregnancy and birth outcomes. This question may become more relevant as younger vapers, among whom the devices gained considerable popularity, start having children. Limited emerging data from animal experiments and human epidemiologic studies suggest that vaping may have negative effects on fertility and pregnancy. “Even if these impacts are less severe than conventional smoking, we really should be thinking about alternate options that may be safer for our patients than inhalation of this aerosol,” said Blair J. Wylie, MD, MPH, a maternal-fetal medicine physician at Beth Israel Deaconess Medical Center in Boston. Dr Wylie reviewed what is known about vaping, including chemicals other than nicotine that have been detected in vape aerosols, and pregnancy at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists. “There’s a lot we don’t know,” she said. “These products were only introduced recently, in 2003. They are marketed aggressively to our youth and have gained tremendous popularity among that population. And it’s only a matter of time, I think, before we see a lot of use in our own patient population.” In a separate study presented at the ACOG meeting, Nicole Izhakoff, a researcher at Florida International University, Miami, and colleagues evaluated the association between e-cigarette use during pregnancy and unfavorable birth outcomes, such as preterm birth, low birth weight, or extended hospital stay for the newborn. The investigators used 2016-2017 survey data from the Pregnancy Risk Assessment Monitoring System. In all, 71,940 women completed the survey, including 859 who reported e-cigarette use during pregnancy. After adjusting for age, race, ethnicity, insurance, maternal education, prenatal care, abuse during pregnancy, and complications during pregnancy, the researchers estimated that the odds of an unfavorable birth outcome were 62% greater among women who used e-cigarettes during pregnancy, compared with those who did not. The researchers lacked information about simultaneous use of alcohol, traditional tobacco, or other drugs, however. “Physicians of all subspecialties, especially those of obstetrics-gynecology and pediatrics, need to increase the implementation of screening for past or current e-cigarette use in at-risk patients,” Ms. Izhakoff and coauthors concluded. “Further research regarding the long-term health effects of e-cigarettes is warranted.”

Vaping and Pregnancy: Inhaled Toxins Among Reasons for Pause

JUN 15 2021

Researchers are trying to understand how e-cigarette use affects pregnancy and birth outcomes. This question may become more relevant as younger vapers, among whom the devices gained considerable popularity, start having children. Limited emerging data from animal experiments and human epidemiologic studies suggest that vaping may have negative effects on fertility and pregnancy. “Even if these impacts are less severe than conventional smoking, we really should be thinking about alternate options that may be safer for our patients than inhalation of this aerosol,” said Blair J. Wylie, MD, MPH, a maternal-fetal medicine physician at Beth Israel Deaconess Medical Center in Boston. Wylie reviewed what is known about vaping, including chemicals other than nicotine that have been detected in vape aerosols, and pregnancy at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists. “There’s a lot we don’t know,” she said. “These products were only introduced recently, in 2003. They are marketed aggressively to our youth and have gained tremendous popularity among that population. And it’s only a matter of time, I think, before we see a lot of use in our own patient population.” In a separate study presented at the ACOG meeting, Nicole Izhakoff, a researcher at Florida International University, Miami, and colleagues evaluated the association between e-cigarette use during pregnancy and unfavorable birth outcomes, such as preterm birth, low birth weight, or extended hospital stay for the newborn. The investigators used 2016-2017 survey data from the Pregnancy Risk Assessment Monitoring System. In all, 71,940 women completed the survey, including 859 who reported e-cigarette use during pregnancy. After adjusting for age, race, ethnicity, insurance, maternal education, prenatal care, abuse during pregnancy, and complications during pregnancy, the researchers estimated that the odds of an unfavorable birth outcome were 62% greater among women who used e-cigarettes during pregnancy, compared with those who did not. The researchers lacked information about simultaneous use of alcohol, traditional tobacco, or other drugs, however. “Physicians of all subspecialties, especially those of obstetrics-gynecology and pediatrics, need to increase the implementation of screening for past or current e-cigarette use in at-risk patients,” Ms. Izhakoff and coauthors concluded. “Further research regarding the long-term health effects of e-cigarettes is warranted.” Wylie coauthored another study related to this topic that was published online May 24, 2021, in the Journal of Maternal-Fetal & Neonatal Medicine. The researchers examined birth weights of children whose mothers use e-cigarettes alone, those whose mothers used both e-cigarettes and conventional cigarettes, and those whose mothers smoked conventional cigarettes only. Their estimates were imprecise, but signaled that e-cigarette use may reduce birth weight. The use of e-cigarettes alone appeared to have less of an impact on birth weight than the dual use of conventional cigarettes and e-cigarettes did. Wylie cautioned that outcomes like birth weight are “pretty crude measures of whether an exposure is okay or not in pregnancy. Many of these toxins that we know that are in the aerosols can cause harm, but they may not be reflected in the absolute value of the birth weight.” In addition, clinicians should avoid focusing on the wrong question when caring for patients. “I think the wrong question is: Is vaping safer than smoking?” Wylie said in an interview. “Metals are going into your lungs. Plastics are going into your lungs. It is hard for me to think that we are going to identify that as our champion smoking cessation strategy in pregnancy.”

Stopping Seizure Meds Before Hospital Discharge Appears Safe in Most Newborns

JUN 15 2021

Researchers observed no difference in functional neurodevelopment or epilepsy among children aged 24 months regardless of whether antiseizure medication was discontinued or maintained in infants at discharge once seizures ceased. Results of the comparative effectiveness study were published in JAMA Neurology. “These results support discontinuing antiseizure medications (ASMs) for most neonates with acute symptomatic seizures prior to discharge from the hospital, an approach that may represent an evidence-based change in practice for many clinicians,” Hannah C. Glass, MDCM, MAS, a pediatric neurologist, founding codirector of the neurointensive care nursery and director of neonatal critical care services at the University of California, San Francisco Benioff Children’s Hospital, and colleagues wrote. ASMs can be maintained in infants for months or years unnecessarily, according to the researchers, due to concerns over continued seizures and early-life epilepsy. Glass and colleagues investigated the impact of early discontinuation of ASM after acute symptomatic neonatal seizures resolved but prior to hospital discharge on functional neurodevelopment and risk for epilepsy at 24 months of age. This prospective, observational, multicenter comparative effectiveness study enrolled 303 infants with acute symptomatic neonatal seizures who were born between July 2015 and March 2018 and enrolled at nine Neonatal Seizure Registry centers with level IV neonatal ICUs and pediatric epilepsy programs. The study included slightly more male infants (56%) than female infants. Glass and colleagues continuously monitored infants using a conventional electroencephalogram. Dosing and treatment were employed under the advisement of local health care professionals. The researchers collected data on ASM type, discontinuation or maintenance and timing and dosage of medication. The researchers also analyzed demographic, clinical and primary seizure causation factors. Parents of the infants reported neurodevelopmental outcomes at 12, 18 and 24 months, corroborated by a medical record review. The primary outcome of the study was functional neurodevelopment at 24 months, which Glass and colleagues measured using the Warner Initial Development Evaluation of Adaptive and Functional Skills questionnaire (WIDEA-FS). Among the 303 infants, 43% of seizures was caused by hypoxic-ischemic encephalopathy, 26% by ischemic stroke, 18% by intracranial hemorrhage and the remaining 13% by another acute brain injury. The local health care professionals prescribed phenobarbital as the first loading ASM in 90% of infants. Upon discharge, a majority (64%) of patients were maintained on ASMs (P < .001). ASM maintenance occurred more often in infants with high seizure burdens, complex clinical courses and abnormal neurological findings at time of discharge. The median treatment length on ASMs in infants with maintained ASMs was 4 months compared with 6 days among those whose medication was discontinued. In the 270 children who returned at 24 months of age for follow-up, the median WIDEA-FS score was 164, with slightly higher scoring (+4 points; 2%) in children whose medication was discontinued prior to a hospital discharge (37%). However, the researchers observed no difference between the two cohorts with regard to functional neurodevelopment or epilepsy at 24 months. “Our findings suggest that staying on antiseizure medication after leaving the hospital doesn’t protect babies from continued seizures or prevent epilepsy and it does not change developmental outcomes,” Glass said in a press release. “Most of the babies in this study went home on antiseizure medications, which suggests we need to re-think standard practice. We’ve never had such robust data from multiple centers to support this type of change for newborns with seizures.”

Guidance Reviewed on 'Kangaroo Care'

MAY 30 2021

When a baby is born prematurely, immediate skin-to-skin contact could save their lives. Instead of placing low-weight newborns in an incubator, new research suggests they should be nestled up close to their mother's chest, or that of a close caregiver's, and fed exclusively on breast milk. This approach, dubbed kangaroo care, has proved to be one of the best and safest ways to treat preterm infants with low birth weights, resulting in fewer infections, higher rates of breastfeeding, and better weight gain in studies. Despite the growing number of benefits, the practice has not been widely adopted. Currently, the World Health Organization recommends continuous kangaroo care for all preterm infants, but only after they are taken away and declared clinically stable in the neonatal intensive care unit (NICU). A randomized controlled trial in five hospitals now suggests the WHO's recommendation separates babies and their mothers too soon. Instead, hospitals should implement a mother-infant care unit with beds and chairs so that hospital staff can look after new parents and babies at the same time. The study was conducted among 3,211 low-weight infants in Ghana, India, Malawi, Nigeria, and Tanzania, who were either assigned immediate kangaroo care in a specially arranged "Mother-NICU" or were separated from the parents for conventional care, with brief moments of touch allowed after the first 24 hours. In the first three days, infants who received immediate skin-to-skin contact were held for roughly 17 hours a day in the Mother-NICU. Meanwhile, those infants placed in incubators or radiant warmers received only 1.5 hours of intermittent daily contact. Compared to conventional neonatal care, those infants who received immediate touch from their parents were 25 percent less likely to die in the first month of life. Continuously held newborns were also less likely to develop hypothermia and bacterial blood poisoning, possibly because these infants had greater exposure to their mother's protective microbiome, were more likely to receive early breast milk, and were handled by fewer people. Avoiding separation stress between the mother and the infant might also have contributed to greater health outcomes. Touch between a baby and its mother has been shown to stabilize the newborn's heart rate, calm its breathing, and decrease its crying. "Keeping the mother and baby together right from birth, with zero separation, will revolutionize the way neonatal intensive care is practiced for babies born early or small," argues Rajiv Bahl, the Head of Maternal and Newborn Health Research and Development at WHO. "This study illustrates that kangaroo mother care has the potential to save many more lives if it is started immediately after birth, a finding with relevance for countries of all income levels." Today, over 96 percent of all infants with a low birth weight are born in developing countries, and these children are particularly vulnerable to infectious disease, developmental delays, and death. Conventional neonatal care is expensive and requires great skill and logistical support, which many countries with lower incomes cannot afford. Kangaroo care, on the other hand, is a safe and effective alternative much easier to implement. The findings support a recent meta-analysis that found kangaroo care after clinical stabilization results in 40 percent lower infant mortality.  Yet, many premature babies don't make it to that stage. Studies reveal nearly 50 percent of neonatal deaths in a number of Asian and African nations occur within 24 hours of delivery, and 80 percent occur in the first week of life, which means many lives are being lost before kangaroo care can be initiated. "The idea of giving skin-to-skin contact immediately after delivery to very small, unstable babies has encountered quite strong resistance, but about 75 percent of deaths occur before the infant has been judged sufficiently stable," explains Nils Bergman from the Karolinska Institutet in Sweden. If low-weight infants receive immediate kangaroo care, the authors of the new study estimate it could save 150,000 underweight newborns each year. WHO is currently in the process of reviewing its guidance on kangaroo care.

Children Born Just Weeks Early Face Higher Risk of Developmental Problems

MAY 30 2021

Children born preterm (before 37 weeks of pregnancy) remain at high risk of developmental difficulties that can affect their behaviour and ability to learn, finds a study published by The BMJ today. These difficulties were found not only in children born extremely preterm (22-26 weeks) but also in those born very and moderately preterm (between 27 and 34 weeks), say researchers. Survival of preterm babies has increased worldwide. Children born early often have developmental issues, but studies have mainly focused on those born extremely preterm (22-26 weeks' gestation) and less is known about children born very and moderately preterm (27-34 weeks' gestation). Given how important it is to identify children most at risk of developmental difficulties, researchers in France set out to describe neurodevelopment among children born before 35 weeks compared with children born at full term. Their findings are based on 3,083 French children aged 5½ born after 24-26, 27-31, and 32-34 weeks gestation who were taking part in the EPIPAGE-2 study (designed to investigate outcomes of preterm children over the past 15 years) and a comparison group of 600 children born at full term. Neurodevelopmental outcomes such as cerebral palsy, sensory impairments (blindness and deafness), and brain function (cognition), as well as behavioural difficulties and movement disorders, were assessed using recognised tests. To further assess the family and social burden of prematurity, measures such as the need for extra support at school, visits to a psychiatrist, speech therapist or physiotherapist, and parental concerns about development, were also recorded. After adjusting for other potentially influential factors, the researchers found that rates of neurodevelopmental disabilities increased as gestational age decreased. For example, among the 3,083 children assessed, rates of severe to moderate neurodevelopmental disabilities were 28%, 19% and 12% and rates of mild disabilities were 39%, 36%, and 34% among children born at 24-26, 27-31 and 32-34 weeks, respectively. Assistance at school was used by 27%, 14% and 7% of children born at 24-26, 27-31, and 32-34 weeks, respectively. And about half of children born at 24-26 weeks received at least one developmental intervention which fell to 26% for those born at 32-34 weeks. Behaviour was the concern most commonly reported by parents. Rates of neurodevelopmental disabilities were also higher in families with low socioeconomic status. This is an observational study, so can't establish cause, and the researchers point to some limitations that may have affected their results. However, by assessing a wide range of developmental and behavioural issues, they were better able to reflect the complexity of difficulties faced by these children and their families. As such, they say their findings indicate that preterm birth "continues to pose a large burden for families, healthcare, and educational systems." Although rates of severe to moderate neurodevelopmental disabilities decreased with increasing gestational age, they point out that around 35% of the moderately to extremely preterm born children had mild disabilities requiring special care or educational services. And a considerable proportion of parents had concerns about their child's development, particularly about behaviour, which warrant attention, they add. "Difficulties faced by these groups of children and their families should not be underestimated," they conclude.

Skip Routine Probiotics for Preemies, AAP Says

MAY 30 2021

The American Academy of Pediatrics (AAP) now recommends against the routine administration of probiotics to preterm infants, particularly the most vulnerable (those whose birth weight is <1000 g), for the treatment or prevention of necrotizing enterocolitis (NEC) and late-onset sepsis. Although probiotics are increasingly given to preterm infants, the AAP notes that the data on their safety and efficacy are inconsistent. In addition, the supplements are not subject to approval by the US Food and Drug Administration (FDA). Therefore, the academy advises clinicians to use extreme caution in selecting preterm neonates to receive these microorganisms and recommends obtaining informed consent from parents after carefully discussing the risks. It also recommends that centers using probiotics conduct surveillance, inasmuch as probiotics can alter a center's flora, potentially affecting all patients. Such centers should also carefully document outcomes, adverse events, and safety. The AAP's clinical report, published online May 24 in Pediatrics, highlights wide differences between commercially available formulations and a lack of regulatory standards in this country. Absent FDA-approved drug labeling, these nutritional supplements cannot be marketed as treatment or prophylaxis, but that has scarcely stopped their use. "Despite lack of availability of a pharmaceutical-grade product, the number of preterm infants receiving probiotics in the United States and Canada is steadily increasing," write Brenda Poindexter, MD, FAAP, chief of neonatology at Children's Healthcare of Atlanta, in Atlanta, Georgia, and members of the AAP's Committee on Fetus and Newborn. Analyses of US collaborative databases indicate that approximately 10% of neonates of extremely low gestational age receive a probiotic preparation in the neonatal intensive care unit (NICU). The use of these preparations varies widely across institutions. "NEC is a devastating morbidity of prematurity, and it's multifactorial. Some babies only given mother's milk still get NEC, and the decision to use these products is a very nuanced one," Poindexter said. "I suspect some people will disagree with the report, and we tried to give folks some wiggle room." Evidence from other countries suggests that probiotics can be protective against NEC, she added, "so not to have a reliable product in this country is very frustrating."

Mother-to-Infant COVID-19 Transmission Is Unlikely

MAY 30 2021

Mothers with a history of COVID-19 exposure during pregnancy are not likely to transmit the infection to their newborns, based on data from more than 2,000 women. “Uncertainty at the onset of the COVID-19 pandemic led to varying postnatal care recommendations for newborns exposed to SARS-CoV-2 in utero,” said Margaret H. Kyle, of Columbia University, New York, and colleagues. The Columbia University Irving Medical Center, an early epicenter of the pandemic, allowed rooming-in and encouraged direct breastfeeding between infected mothers and their newborns while adopting extensive safety measures, the researchers said. In a study presented at the virtual meeting of the Pediatric Academic Societies, the researchers conducted a retrospective chart review of all newborns born at the medical center from March 22, 2020, through August 7, 2020. The study was part of Columbia University’s ongoing COVID-19 Mother Baby Outcomes (COMBO) initiative to “describe the health and well-being of mother-infant dyads with and without prenatal SARS-CoV-2 infections,” according to the researchers. During the study period, the researchers identified newborns of 327 women who tested positive for COVID-19 at any point during pregnancy and compared them to newborns of 2,125 unexposed women. Demographics were similar between the groups. Overall, the total test positivity was 0.7% for exposed newborns; 1.0% tested positive on an initial test, and 0% were positive on retest. During the newborn hospital stay and a 2-week follow-up, 0% of all newborns showed clinical evidence of infection. No significant differences were noted between exposed and unexposed newborns in clinical outcomes including gestational age, mode of delivery, 5-minute Apgar score, heart rate, respiratory rate, or temperature. Although more infants of COVID-19–exposed mothers compared with unexposed mothers had an emergency department visit within the first 14 days of life (6% vs. 3%, P = .002), none of the infants was diagnosed with COVID-19 during these visits. Cough, fever, congestion, or bilirubin were more frequent reasons for emergency department visits in the exposed infants compared with unexposed infants, but these differences were not significant. The study findings were limited by several factors, including the retrospective design and the limited follow-up period to only the first 2 weeks of life, the researchers noted. In addition, perinatal transmission rates were available only for the 202 newborns who were followed up in the hospital system, they said. However, the results suggest that the risk of mother-to-newborn vertical transmission of COVID-19 remains low, even when mothers are breastfeeding and infants are rooming in, they concluded.

Webinar Organized about Pulse Oximetry from a Neonatologist’s Perspective

MAY 22 2021

Pulse Oximetry: The Neonatologist’s Perspective is an upcoming webinar set for June 8 at 11:00 AM PDT. Panelists: Mitchell Goldstein, MD, Professor of Pediatrics Neonatal Medicine and Loma University School of Medicine and Director of the Neonatal ECMO Program, Division of Neonatology, Department of Pediatrics at Loma Linda University Children’s Hospital; Vijay Dhar, MD, Division Chief of Neonatology Children’s Hospital of Orange County, University of California, Irvine; Anand Sampath, Executive Vice President Operations and Clinical Research Masimo. Moderator: Vicki Huber RN, MSN, MBA, CHE, Chief Nursing Officer, Masimo. This live webinar brings together respected neonatologists alongside engineering experts to offer perspective and clarity regarding how Masimo Signal Extraction Technology (SET) has overcome the challenges associated with monitoring neonates. The panel will also address pulse oximetry performance including recent claims about speed to post readings, accuracy, and alarm management. Join us to discover how the right technology can make a difference for all patients—especially vulnerable neonates. Register to Attend Now: https://bit.ly/3oBurO1

Company Introduces Neonatal Transilluminator for Single Patient Use

MAY 14 2021

Neotech is proud to introduce a neonatal transilluminator developed specifically for single patient use: NeoGlo Disposable. NeoGlo Disposable is available with red or white LED lights. It is lightweight, compact, and features a USB power connector. No batteries required. “Infection in general, and especially cross contamination, is a great concern in the NICU. I approached Neotech to develop a small, inexpensive neonatal transilluminator that could be used for one patient and then discarded when the patient is sent home,” Professor Ruben Bromiker, Neonatologist said. “I’m thrilled to see this product come to fruition. Having one transilluminator per patient will also make it more available, thus encouraging the staff to use it. And studies show that the use of transillumination improves the chances of success; reducing the number of pricks we give a patient.” After the successful launch of the original NeoGlo, Neotech set out to deliver Dr Bromiker’s original, hospital-driven concept. “Dr Bromiker came to us with a fairly simple idea: an affordably-priced device that could be plugged into a USB power source,” Sara Dimmitt, Manager of New Product Development said. “It was focused on the needs of the international market. After some market research in the US, his idea evolved into a reusable neonatal transilluminator with multiple light settings. But we always intended on revisiting a disposable option. And with Philips discontinuing their Wee-Sight, it’s perfect time to introduce NeoGlo Disposable to the market.” Now, Neotech offers two great transillumination options. The original reusable and the new NeoGlo Disposable.

55 New Chemicals Found in Pregnant Women, Their Newborns

MAY 14 2021

Fifty-five chemicals never before reported in humans were found in pregnant women, according to a study from the University of California San Francisco. The chemicals likely come from consumer products or industrial sources, researchers say. Findings were published online in Environmental Science and Technology. Co-first authors Aolin Wang, PhD, and Dimitri Panagopoulos Abrahamsson, PhD, postdoctoral fellows in UCSF's obstetrics and gynecology department, and colleagues found 109 chemicals in the blood of pregnant women, including 42 "mystery chemicals" whose sources and uses are not known. The chemicals were also found in their newborns, tests from umbilical cord blood show, suggesting the chemicals cross through the placenta. Among the chemicals, 40 are used as plasticizers, 28 are used in cosmetics, another 25 are used in consumer products, 29 as pharmaceuticals, 23 as pesticides, three as flame retardants, and seven are PFAS [per- and polyfluoroalkyl substances] compounds used in multiple applications including carpeting and upholstery, the authors report. Senior author Tracey Woodruff, PhD, MPH, characterized their discoveries as "disturbing." "We know it's a chemical registered to be manufactured and it's used in commerce, but we don't know where," she explained. "That's very disturbing that we can't trace them and that shows a failure in public policy and government." "Exposures are occurring without our consent," said Woodruff, a former US Environmental Protection Agency scientist, who directs the Program on Reproductive Health and the Environment (PRHE) and the Environmental Research and Translation for Health (EaRTH) Center, both at UCSF.

Blood Markers May Help Predict Delivery Time

MAY 14 2021

Scientists have identified markers in blood that may indicate labor is approaching, according to a new study. Through an analysis of blood samples gathered during the second and third trimesters of 53 women, researchers identified a combination of factors that predicted the approach of labor to within a two week window, according to the report published in Science Translational Medicine. “Currently it is hard for an obstetrician to give an accurate time when a woman is going to go into labor,” said coauthor Dr Brice Gaudilliere of Stanford University. “This can be an issue both for pregnancies that turn out to be preterm and those complicated by being post term.” “By measuring various factors that represent many physiological systems that are important in the maintenance of pregnancy—in particular the immune system—we are able to predict when labor will occur without relying on an estimate of the gestational age,” Gaudilliere said. Gaudilliere and his colleagues analyzed blood samples from 53 women who went into labor spontaneously, including five who delivered preterm. Blood was collected two or three times from the women during the last 100 days of their pregnancies, with each sample analyzed for 7,142 metabolic, protein and single-cell immune features. The data was plotted against the number of days before labor that each sample was collected, and via mathematical modeling, the researchers identified which features in the blood best predicted the onset of labor. Once they had isolated the factors that appeared to presage the onset of labor within a window of two weeks, Gaudilliere and his team tested their results on the pregnancies of 10 more women, which confirmed the researchers were on the right track. Overall, the researchers found that a surge in steroid hormone metabolites and interleukin-1 receptor type 4 preceded labor, coinciding with a switch from immune activation to regulation of inflammatory responses. Gaudilliere and his team hope that the study’s findings will yield a test that obstetricians can use to predict labor within the next two to three years.

Neonatal Nurses, Doctor Help Woman Who Delivered Baby on Plane

MAY 14 2021

Three neonatal intensive care nurses and a family physician were in the right place — on an airliner traveling to Hawaii — at the right time — when a woman unexpectedly delivered a baby prematurely on the flight. The medical professionals sprang into action to keep baby Raymond, who came into the world at 29 weeks, healthy until the flight got to Honolulu, according to a news release from Hawaii Pacific Health. Dale Glenn, MD, a family physician with Hawaii Pacific Health, said there was an emergency call for a doctor halfway through the Delta flight that left Salt Lake City for Honolulu on April 28. “I let the flight attendant know that I'm a physician and she said we have a woman having a baby, so I hurried over to see what I could do,” he said, according to the release. Three NICU nurses from North Kansas City Hospital — Lani Bamfield, Amanda Beeding, and Mimi Ho — answered the call. "I went to see what was going on and see her there holding a baby in her hands, and it's little," Bamfield said, according to the news release. The mom, Lavinia "Lavi" Mounga of Orem, Utah, said she was more than a little surprised. "I just didn’t know I was pregnant," Mounga said in a video interview released from Hawaii Pacific Health, according to Q13 Fox of Seattle. "And this guy just came out of nowhere." The nurses and the doctor improvised to keep Raymond safe for the rest of the flight. Glenn said they used shoelaces to cut and tie the umbilical cord, made baby warmers out of bottles that were microwavable, and measured the baby’s heart rate with an Apple Watch. “We didn’t have the usual tools found in a neonatal intensive care unit, so there were a lot of vital signs we couldn’t track,” Glenn said.

Latest Emollient Data Discouraging for Atopic Dermatitis Prevention

MAY 14 2021

Emollients don't prevent atopic dermatitis (AD), but they might have untapped potential as treatment, two new studies suggest. The results of a prevention study, in which parents slathered their babies with petrolatum, are particularly discouraging. Earlier studies had led researchers to hope this approach could stop not only AD but perhaps other related allergic conditions. Instead, the babies who were in the petrolatum group in the Barrier Enhancement for Eczema Prevention Study (BEEP) were more likely to develop food allergies as well as skin infections than babies who received standard skin care. "So, the parents of newborn babies should not be advised to use emollients to prevent eczema developing," said Joanne Chalmers, PhD, a senior research fellow at the Center of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom. In another study, an experimental nanofiber dressing impregnated with palmarosa oil significantly improved symptoms of the condition. Both studies were presented at the International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting. The BEEP results were also published in The Lancet. A "sizeable body of evidence" supports the use of emollients for the treatment of mild AD and flares, Chalmers said. Skin barrier dysfunction precedes the development of AD. Mutations in the filaggrin gene are associated with skin barrier dysfunction and the development of AD. There is no cure, and treatments are burdensome. On the basis of these data, Chalmers and her colleagues thought applying emollients to babies was worth a try. They approached families with newborn babies who were at high risk of developing AD because they had at least one first-degree relative with AD, allergic rhinitis, or asthma.

Latest Data Added to Poster

MAY 4 2021

Mallinckrodt plc, a global biopharmaceutical company, announced that data from its Phase 4 observational registry comparing the safety and effectiveness of INOmax (nitric oxide) gas, for inhalation, in term and near-term (TNT) neonates to that in preterm (PT) neonates with pulmonary hypertension (PH) will be presented in a poster at The Pediatric Academic Societies (PAS) 2021 Virtual Meeting. The safety and efficacy of INOmax in premature neonates has not been evaluated by the US Food and Drug Administration. INOmax has been on the market in the US since 2000 and is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. The primary outcome measure of the registry was the number of PT neonates and TNT neonates with a significant response to INOmax, which was defined as at least a 25 percent improvement (decrease) from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOmax treatment. A total of 50 (90.9 percent) PT and 75 (88.2 percent) TNT neonates achieved a ≥25 percent decrease in OI/SOI during treatment with INOmax. Efficacy in the PT group demonstrated non-inferiority (95 percent confidence interval: 0.0267 [-0.0333, 0.0868], with a pre-defined margin of -0.1452). In addition, the proportion of neonates with ≥25 percent decrease in OI/SOI was similar across severity groups with no significant difference in time to improvement between groups. "These registry findings help expand our understanding of a potential role of inhaled nitric oxide therapy in preterm infants with hypoxic respiratory failure with pulmonary hypertension," said study author Leif D. Nelin, M.D., Division Chief of Neonatology at Nationwide Children's Hospital. Persistent pulmonary hypertension of the newborn (PPHN) is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life. The registry trial was conducted to examine the utility of INOmax in pre-term neonates. Due to the seriousness of the condition, a randomized controlled trial cannot be conducted in the pre-term neonate population. Overall, 21 adverse events of special interest were reported in 17 patients, all of which were classified as serious events, and no serious adverse events were attributed to the study drug. "After ending this registry much earlier than anticipated last year based on positive findings, Mallinckrodt is extremely pleased to be able to share these important data with the healthcare community and add to the body of research and real-world data for this vulnerable patient population," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt.

Parents Battle Hospitals Over Rights

MAY 3 2021

Ashley Lamendola was still a teen when medical staff at St. Petersburg General Hospital delivered the awful news that would change her life forever: Her newborn son, Hunter, had suffered profound brain damage and would do little more than breathe without help. “It was like an atomic bomb went off in my life,” she said. Lamendola believed the hospital was partly responsible for Hunter’s birth injuries. But Florida is one of two states that shield doctors and hospitals from most legal actions arising from births that go catastrophically wrong. Lamendola filed a lawsuit against St. Petersburg General anyway, and when it appeared she was gaining traction, the hospital advanced an extraordinary argument. It suggested that Hunter’s mother was not acting in her son’s best interest and that a critical decision about his future care should be put in the hands of an independent guardian and a judge. Lamendola, attorneys said, was pursuing her own self-interest by refusing to participate in the quasi-government program that compensates the families of children injured at birth. Under the program, known as the Birth-Related Neurological Injury Compensation Association, or NICA, the state provides $100,000 upfront and pays for “medically necessary” care for the child’s lifetime. In exchange, parents give up their right to sue hospitals and doctors, lawsuits that can result in judgments or settlements in the tens of millions of dollars. By choosing to “pursue her own speculative, complicated civil lawsuit” rather than permitting her son to accept his “vested” NICA benefits, Lamendola was trying to profit from Hunter’s injuries, St. Petersburg General attorneys argued in a court filing. They underscored the words “her own.” Had she accepted Hunter’s inclusion in NICA, “the Mother would be unable to pursue her own civil lawsuit, seeking her own separate monetary damages for the Child’s injuries,” the lawyers added. “You carry a child for nine months, and then you finally get to hold them — eventually in my case,” said Lamendola, who was employed as a customer service rep at an AutoZone when she gave birth. “And you take care of their every want and need, and you put a child before you. I mean, once you have a child, there is no more you. It’s them. It’s us. It’s that baby that needs you and needs everything from you. I didn’t understand how somebody who wasn’t me could know what he wants and needs. I knew every sound, every movement, every seizure that he had,” Lamendola said. “And to think that somebody thought they knew better than me. It was wild to me.” The battle between parents like Lamendola and hospitals like St. Petersburg General can seem like a gross mismatch: Lamendola was a single mom who made $10.50 an hour and lived with her mother. HCA Healthcare, which owns St. Petersburg General, is one of the nation’s largest for-profit hospital chains, with 180 hospitals, 280,000 employees and revenues of $51.5 billion in 2020. For hospitals facing stunningly high settlements or verdicts, NICA, the state’s no-fault program, is a valuable legal tool — a club to bat away expensive lawsuits. At the cost of $50 per live birth, hospitals can protect themselves from multimillion-dollar judgments. Paolo Annino, who heads the Children’s Advocacy Clinic at the Florida State University College of Law, said attempts to restrict a parent’s authority through the appointment of a guardian are unusual: In child welfare disputes, for example, parents must be found unfit by a judge before being stripped of their right to decide what’s best for their children. “What we have here is a scenario where there’s no allegation of offending parents at all,” he said. “The parent is, with very few exemptions, the one who makes the child’s health care decisions.” NICA came under fire this month after a series of reports by the Miami Herald and the investigative reporting newsroom ProPublica. Families complained that the $100,000 grant — unchanged since 1988 — is inadequate, and that payments for medical procedures or equipment are routinely slow walked or denied entirely. After the articles were published, state leaders professed outrage and promised a comprehensive fix to the program. Here is how NICA works: After a baby is born brain damaged, parents can file a lawsuit against the hospital and doctor. The defendants then can ask the judge to pause the suit and order the parent to file a NICA claim. That petition is heard in a separate venue by an administrative judge, who then decides if the case is “compensable.” Ultimately the administrative judge determines whether NICA applies or if the parents can resume their lawsuit. To qualify for NICA, in addition to having physical and cognitive impairments, a child must weigh at least 2,500 grams (5.5 pounds) at birth and be delivered in a hospital. When children don’t fit those criteria, parents retain the ability to sue. For the roughly 440 Florida children covered by NICA over the past 33 years, some of them now deceased, the program wasn’t really a choice. It was a mandate, with a few exceptions. One exception is when OB-GYNs fail to pay a $5,000 annual assessment. Nearly 1 in 4 licensed obstetricians statewide does not pay. Another is when a hospital doesn’t pay its $50-per-birth fee. Parents can also argue that they weren’t properly notified by their hospital or doctor of their participation in NICA with enough lead time to choose another provider. When parents like Lamendola attempt to invoke these exceptions, the fight can become fierce — and expensive.

Latest Emollient Data Discouraging for Atopic Dermatitis Prevention

MAY 3 2021

Emollients don't prevent atopic dermatitis (AD), but they might have untapped potential as treatment, two new studies suggest. The results of a prevention study, in which parents slathered their babies with petrolatum, are particularly discouraging. Earlier studies had led researchers to hope this approach could stop not only AD but perhaps other related allergic conditions. Instead, the babies who were in the petrolatum group in the Barrier Enhancement for Eczema Prevention Study (BEEP) were more likely to develop food allergies as well as skin infections than babies who received standard skin care. "So, the parents of newborn babies should not be advised to use emollients to prevent eczema developing," said Joanne Chalmers, PhD, a senior research fellow at the Center of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom. In another study, an experimental nanofiber dressing impregnated with palmarosa oil significantly improved symptoms of the condition. Both studies were presented at the International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting. A "sizeable body of evidence" supports the use of emollients for the treatment of mild AD and flares, Chalmers said. Skin barrier dysfunction precedes the development of AD. Mutations in the filaggrin gene are associated with skin barrier dysfunction and the development of AD. There is no cure, and treatments are burdensome. On the basis of these data, Chalmers and her colleagues thought applying emollients to babies was worth a try. They approached families with newborn babies who were at high risk of developing AD because they had at least one first-degree relative with AD, allergic rhinitis, or asthma. They assigned 693 infants to the emollient group and 701 to the control group. They gave the families in the emollient group a choice of Doublebase Gel (Dermal Laboratories) or Diprobase Cream (Bayer). Both products contain petrolatum and have no ingredients known to have harmful effects. These products are commonly used in the UK National Health Service. The researchers asked the families to apply the product they chose to their baby at least once daily. The products were to be applied to the whole body (excluding the scalp) until the baby reached age 1 year. They advised the families to apply emollient after every bath, even if they had already applied it earlier that day. The control group was given standard advice: avoid harsh soaps and the use emollients unless the baby developed eczema. Most families in the emollient group adhered to the regimen. Adherence dropped only slightly, from 88% at 3 months to 74% at 12 months, among those for whom complete questionnaire data were available.

Stethoscope and Doppler May Outperform Newer Fetal Monitoring Tools

MAY 3 2021

For intrapartum fetal surveillance, the old way may be the best way, according to a meta-analysis involving more than 118,000 patients. Intermittent auscultation with a Pinard stethoscope and handheld Doppler was associated with a significantly lower risk of emergency cesarean deliveries than newer monitoring techniques without jeopardizing maternal or neonatal outcomes, reported lead author Bassel H. Al Wattar, MD, PhD, of University of Warwick, Coventry, England, and University College London Hospitals, and colleagues. “Over the last 50 years, several newer surveillance methods have been evaluated, with varied uptake in practice,” the investigators wrote in the Canadian Medical Association Journal, noting that cardiotocography (CTG) is the most common method for high-risk pregnancies, typically coupled with at least one other modality, such as fetal scalp pH analysis (FBS), fetal pulse oximetry (FPO), or fetal heart electrocardiogram (STAN). “Despite extensive investment in clinical research, the overall effectiveness of such methods in improving maternal and neonatal outcomes remains debatable as stillbirth rates have plateaued worldwide, while cesarean delivery rates continue to rise,” the investigators wrote. Previous meta-analyses have relied upon head-to-head comparisons of monitoring techniques and did not take into account effects on maternal and neonatal outcomes. To address this knowledge gap, Dr Al Wattar and colleagues conducted the present systematic review and meta-analysis, ultimately including 33 trials with 118,863 women who underwent intrapartum fetal surveillance, dating back to 1976. Ten surveillance types were evaluated, including intermittent auscultation with Pinard stethoscope and handheld Doppler, CTG with or without computer-aided decision models (cCTG), and CTG or cCTG combined with one or two other techniques, such as FBS, FPO, and STAN. This revealed that intermittent auscultation outperformed all other techniques in terms of emergency cesarean deliveries and emergency cesarean deliveries because of fetal distress. Specifically, intermittent auscultation significantly reduced risk of emergency cesarean deliveries, compared with CTG (relative risk, 0.83; 95% confidence interval, 0.72-0.97), CTG-FBS (RR, 0.71; 95% CI, 0.63-0.80), CTG-lactate (RR, 0.77; 95% CI, 0.64-0.92), and FPO-CTG-FBS (RR, 0.81; 95% CI, 0.67-0.99). Conversely, compared with IA, STAN-CTG-FBS and cCTG-FBS raised risk of emergency cesarean deliveries by 17% and 21%, respectively. Compared with other modalities, the superiority of intermittent auscultation was even more pronounced in terms of emergency cesarean deliveries because of fetal distress. Intermittent auscultation reduced risk by 43%, compared with CTG, 66% compared with CTG-FBS, 58%, compared with FPO-CTG, and 17%, compared with FPO-CTG-FBS. Conversely, compared with intermittent auscultation, STAN-CTG and cCTG-FBS increased risk of emergency cesarean deliveries because of fetal distress by 39% and 80%, respectively. Further analysis showed that all types of surveillance had similar effects on neonatal outcomes, such as admission to neonatal unit and neonatal acidemia. Although a combination of STAN or FPO with CTG-FBS “seemed to improve the likelihood of reducing adverse neonatal outcomes,” the investigators noted that these differences were not significant in network meta­-analysis. “New fetal surveillance methods did not improve neonatal outcomes or reduce unnecessary maternal interventions,” Dr Al Wattar and colleagues concluded. “Further evidence is needed to evaluate the effects of fetal pulse oximetry and fetal heart electrocardiography in labor.”

Breastfeeding Safe for Mothers With COVID-19 Infection

APR 15 2021

Nursing mothers who receive a COVID-19 vaccine may pass protective antibodies to their babies through breast milk for at least 80 days following vaccination, suggests new research from Washington University School of Medicine in St. Louis. "Our study showed a huge boost in antibodies against the COVID-19 virus in breast milk starting two weeks after the first shot, and this response was sustained for the course of our study, which was almost three months long," said first author Jeannie Kelly, MD, assistant professor of obstetrics and gynecology. "The antibodies levels were still high at the end of our study, so the protection likely extends even longer." Based on the small study, involving five mothers who provided frozen breast milk samples after receiving the two-dose Pfizer-BioNTech coronavirus vaccine, the research provides some of the first peer-reviewed evidence that breastfeeding confers a long-lasting immune response in the nursing infants and toddlers of vaccinated mothers. "There is so much vaccine misinformation out there right now—really scary, misleading posts on social media that are designed to scare moms—so we felt like we needed to look at the science," Kelly said. "We know that these types of antibodies coat babies mouths and throats and protect against disease when a baby is drinking breast milk. So, getting vaccinated while breastfeeding not only protects mom, but also could protect the baby, too, and for months." Published March 30 in the American Journal of Obstetrics and Gynecology, the study tracked levels of COVID-19 antibodies in breast milk from a baseline before the mothers' first vaccinations and on a weekly basis for 80 days after those initial vaccinations. While other recent research has shown that COVID-19 vaccines generate antibodies that are passed to nursing infants through breast milk, this is thought to be the first study to track specific levels of these antibodies in breast milk over an extended time period. The babies of women included in the study ranged in age from one month to 24 months old. To gauge immune response in the breast milk, researchers monitored levels of the immunoglobulins IgA and IgG, which are antibodies deployed by the immune system to fight infections in babies. Findings confirm that breast milk contains elevated levels of the IgA and IgG antibodies immediately following the first dose of vaccination, with both antibodies reaching immune-significant levels within 14 to 20 days of first vaccination in all participants. "Our study is limited by a small number of participants, but the findings provide encouraging news about the potential immune benefit to breast-feeding infants after vaccination," said study senior author Misty Good, MD, an assistant professor of pediatrics, also at Washington University. "Our paper is the first that has shown COVID-19 antibodies persist in breast milk for months following the mother's vaccination." The Washington University findings are similar to prior studies on maternal vaccination, which have shown high levels of antibodies in breast milk for up to six months following vaccination for influenza and whooping cough. While further studies of maternal COVID-19 vaccination are needed to characterize the length of antibody production in breast milk and the effect on infant infection rates, recent research continues to confirm that the COVID-19 vaccine offers real benefits for protecting both mother and child. "We do know that COVID-19 infection is more severe during pregnancy and the main benefit of vaccination is to provide protection for moms before they become really sick, which can also be dangerous to their fetus," Kelly said. "There have now been almost 70,000 pregnant people vaccinated against COVID 19 with no evidence of harm." "We're now seeing a cascade of new data that indicate maternal vaccines are also going to help protect babies—both through transfer of antibodies through the placenta during pregnancy and through the breast milk during lactation," Kelly said. "This is information we didn't have a few months ago and it's really helping us better counsel our patients who are considering getting the vaccine. I'm telling my pregnant and breastfeeding moms that I strongly recommend that they get vaccinated as soon as possible."

Ocular Abnormalities Not Likely in Newborns of SARS-CoV-2-infected Mothers

APR 15 2021

Unlike pathogens such as Cytomegalovirus and Zika, SARS-CoV-2 is not likely to cause ocular problems in newborns whose mothers were infected with the virus during pregnancy, a new case series suggests. In an analysis of data from 165 infants born in Sao Paulo, Brazil, researchers found that just six newborns had positive PCR findings for SARS-CoV-2, and none of the six displayed ocular abnormalities, according to the report published in JAMA Ophthalmology. “Vertical transmission is a serious complication of viral diseases occurring during pregnancy and often may lead to ocular manifestations,” said the study’s lead author, Dr Olivia Kiappe, a retina and vitreous fellow and researcher at the Federal University of Sao Paulo. “Cytomegalovirus and Zika virus are examples of viral infections that can have devastating consequences to the eye of the newborn,” she said in an email. “This study suggests that there is not a moderate or high increased risk of ocular abnormalities in newborns of mothers with COVID-19,” Dr Kiappe said. “Although more data are needed, vertical transmission of SARS-CoV-2 seems possible and should be a concern. Considering the noninvasive nature of the ophthalmological examination, ocular manifestations should be further investigated.” To investigate the possibility that SARS-CoV-2 transmitted in utero by pregnant women could cause eye problems, Dr Kiappe and her colleagues enrolled 165 newborns whose mothers had been diagnosed with SARS-CoV-2 infections. The babies were born at three maternity hospitals in Sao Paulo between April and November of 2020. Of the 165 infants, 123 (74.5%) were born full-term, while 42 (25.4%) were born preterm. Six of the newborns had positive PCR tests of oronasopharyngeal swab samples for SARS-CoV-2. One infant tested positive within 18 days, suggesting possible horizontal transmission, the authors note, while the other five tested positive on the first day of life, suggesting vertical transmission. None of these newborns had ocular abnormalities. Among the newborns who tested negative, one presented with venous engorgement and vascular tortuosity, while seven had intraretinal hemorrhages and two were diagnosed as having retinopathy of prematurity. It will be important to do long-term follow-up on these babies because they were examined so early in life, said Dr Christopher Golden am associate professor of pediatrics at the Johns Hopkins University School of Medicine, in Baltimore. “The developing eye is at risk any time there is an infection involved, especially when the infection occurs when the mom is still pregnant,” Dr Golden said. “Infections can alter the way the nervous tissue in the eye develops.” As for the findings in children who tested negative for the virus, “they could be the result of C-section delivery or just premature delivery,” Dr Golden said. The new report is looking at “something that is really worth studying being that some of the systemic findings in COVID-19 are heavily involving vasculature and clotting and since the eye is one of the most heavily vascularized organs,” said Dr. Erin Walsh, the co-director of pediatric ophthalmology and strabismus services at Mount Sinai in New York City. “There has been a study showing some issues in the retinas of adults with COVID-19. So, I definitely think it’s worth looking for.” One issue of with the current study is “a lack of any sort of real discussion on what normal birth patterns of the retina are,” Dr. Walsh said. Moreover, “there was no comment on other systemic issues such as cardiovascular health (that might have explained the findings in the infants who did not test positive for COVID-19).” After the experience with Zika, it makes sense to look for possible eye issues relating to COVID-19, Dr Walsh said. “With all the multisystemic inflammation that’s been occurring in kids, I would bet, down the road, when rigorous studies are done, researchers might actually find some subtle or not so subtle vascular findings in the retina.”

Extreme Preemies With Neurodevelopmental Impairment at Age 2 May Improve by Age 10

APR 15 2021

More than one quarter of babies who were born extremely premature and display neurodevelopmental impairments at age 2 may improve significantly by age 10, according to a new study. An analysis of data from 802 children who were born extremely premature, revealed that 63% of 227 classified as having moderate to severe neurodevelopmental impairment (NDI) at age 2, had none to mild NDI at age 10. Among 108 children classified as having profound NDI at 2 years, 36% had none to mild NDI at 10 years, researchers report in Pediatrics. Overall, 67% of the children had no change in NDI classification between 2 and 10 years of age, 27% improved and 5% worsened, the authors note. “I hope these findings will allow parents and medical professionals to leave room for optimism when they hear a baby has been born extremely premature with profound neurodevelopmental impairments,” said Dr. Genevieve Taylor, an assistant professor in the division of neonatal and perinatal medicine at the University of North Carolina, Chapel Hill. “It’s definitely a complex issue and there are limitations to our study, but it’s exciting that in this cohort we found even in those kids classified as having severe neurodevelopmental impairment at age 2, many went on to have improved classifications at 10.” The study underscores how plastic kids’ brains are at age 2, Dr. Taylor said. “It demonstrates that kids at age 2 are still developing and that kids are resilient,” she added. “It also shows that there are some limitations of assessing neurodevelopmental impairment at age 2.” To take a closer look at how very premature children who start out with severe NDI develop over time, Dr. Taylor and her colleagues turned to data from the Extremely Low Gestational Age Newborn (ELGAN) Study, a cohort of children born extremely premature at multiple sites in the U.S. who had neurodevelopmental assessments at 2 and 10 years of age. The researchers hypothesized that NDI at age 2 would have limited predictive accuracy for NDI at age 10. Out of 1,506 infants, 80% survived. Data were sufficient for analysis in 67% of those children (802), of whom 5% were born at 23 weeks’ gestation, 15% at 24 weeks, 20% at 25 weeks, 25% at 26 weeks, and 35% at 27 weeks. When the children were 2, trained examiners administered the Bayley Scales of Infant Development Second Edition (BSID-II), performed a standardized neurologic examination, and assigned Gross Motor Function Classification System (GMFCS) scores. For children with an impairment that precluded BSID-II testing as well as those for whom more than two test items were omitted, the Vineland Adaptive Behavior Scales Motor Skills Domain was used instead of the BSID-II. At age 10, IQ was assessed with the Differential Ability Scales, Second Edition (DAS-II). The proportion of children classified as having profound NDI decreased from 13% at age 2 to 6% at age 10. The proportion classified as having moderate to severe NDI decreased from 28% to 17%. The proportion classified as having none to mild NDI increased from 58% to 77%. “Having a preemie is very scary,” said Kimberly Blair, an associate professor of psychiatry at the University of Pittsburg and senior academic director of the UPMC Matilda Theiss Early Childhood Behavioral Health Program.

Pediatricians Call on Biden to Overturn Trump Neonatal Care Order

APR 15 2021

Pediatric bioethicists are calling for President Joe Biden to revoke a Trump Administration executive order that restricts physicians’ ability to withhold therapies from extremely premature newborns. The 2020 Executive Order on Protecting Vulnerable Newborn and Infant Children “reduces the complex and nuanced discussion of the outcomes of prematurity to a single sentence and single outcome: mortality,” Dr Jennifer Kett writes in a new Pediatrics perspective. Even when physicians have no medical treatment to offer babies born before 24 weeks, the order could compel them to intervene in an effort to keep their hearts beating, said Kett, associate medical director for pediatric palliative care at Seattle Children’s Research Institute. “These are very difficult, nuanced decisions we make in consultation with families,” Kett told Reuters Health in a phone interview. “The worry is that physicians and medical teams may be less willing to consider or counsel families about other challenges of extremely pre-term birth besides survival.” Measures the order would require could extend a newborn’s painful life with no long-term hope, she said. “The order’s really focused on survival. There are other factors besides the risk of dying,” she said. The 2020 order is the most recent in a line of legislative actions dating back to the Baby Doe regulations, inspired by the prolife movement, of the 1980s, the perspective says. The Baby Doe regulations restricted the ability of families and physicians to consider quality of life in decision-making about infant care. In the decades since Baby Doe, improvements in neonatal treatments have led hospitals to offer interventions to younger and younger newborns. At the same time, clinical practice has increasingly incorporated parents into decisions about the best interests of their premature newborns, and hospital ethics committees have formed to respond to conflicts when they arise. The Trump Administration order risks undermining the progress, and it portrays the relationship between families and doctors as adversarial, the perspective says.

Maternal Caffeine Consumption, Even Small Amounts, May Reduce Neonatal Size

APR 15 2021

For pregnant women, just half a cup of coffee a day may reduce neonatal birth size and body weight, according to a prospective study involving more than 2,500 women. That’s only 50 mg of a caffeine day, which falls below the upper threshold of 200 mg set by the American College of Obstetricians and Gynecologists, lead author Jessica Gleason, PhD, MPH, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md, and colleagues reported. “Systematic reviews and meta-analyses have reported that maternal caffeine consumption, even in doses lower than 200 mg, is associated with a higher risk for low birth weight, small for gestational age (SGA), and fetal growth restriction, suggesting there may be no safe amount of caffeine during pregnancy,” the investigators wrote in JAMA Network Open. Findings to date have been inconsistent, with a 2014 meta-analysis reporting contrary or null results in four out of nine studies. Gleason and colleagues suggested that such discrepancies may be caused by uncontrolled confounding factors in some of the studies, such as smoking, as well as the inadequacy of self-reporting, which fails to incorporate variations in caffeine content between beverages, or differences in rates of metabolism between individuals. “To our knowledge, no studies have examined the association between caffeine intake and neonatal anthropometric measures beyond weight, length, and head circumference, and few have analyzed plasma concentrations of caffeine and its metabolites or genetic variations in the rate of metabolism associated with neonatal size,” the investigators wrote.

 

Enrollment Completed in Clinical Trial Evaluating Effect of Exclusive Human Milk Diet

APR 07 2021

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, announced today that enrollment is now complete in a clinical trial evaluating the effect of an exclusive human milk diet (EHMD), including a specialty fortifier, for term infants who have undergone a corrective procedure for single ventricle physiology (SVP), a life-threatening congenital heart defect (CHD). SVP refers to many types of CHDs that include specific anatomical conditions that result in the body having only one functioning heart ventricle. Because the body needs two healthy heart ventricles to pump blood around the body successfully, infants with SVP may have severe complications unless treated through a series of surgeries shortly after birth. “We’re hopeful that an EHMD, including a specialty fortifier, will demonstrate improved short- and long-term health outcomes for this population of fragile term infants,” said principal investigator Dr. Cynthia Blanco, MD, of the University of Texas Health Science Center in San Antonio. “This study allows us to examine the role of human milk nutrition for this specific infant population who require a great deal of nutrients to catch up on growth, heal from multiple surgeries, and avoid further health complications.” Blanco approached Prolacta about developing a fortifier for infants requiring cardiac surgery. SVP is rare, with only approximately 1,500 infants a year born in the U.S. with this condition. These infants face growth and feeding intolerance issues, which are further complicated by the infants being severely fluid restricted. To meet the specific nutritional needs of these fragile infants requiring surgery, a specialty fortifier was developed and evaluated for potential use in this specific patient population. “We were moved by Dr. Blanco’s commitment to her patients and wanted to help her feed these fragile single ventricle physiology infants undergoing a corrective procedure,” said Scott Elster, CEO of Prolacta. “It is gratifying to have the opportunity to provide human milk nutrition to other infant populations in need — regardless of the relative size of that patient population.” The study, “A Randomized Controlled Trial to Evaluate Growth Velocity and Clinical Outcomes of Infants With Single Ventricle Physiology Fed an Exclusive Human Milk Diet With Early Nutritional Fortification Following Surgical Repair,” successfully enrolled 107 infants undergoing a corrective procedure for SVP. These infants were randomly assigned to receive either Prolacta’s human milk-based fortifier as part of an EHMD, or a cow milk-based fortifier as part of a human/cow milk diet (depending on hospital protocol). The trial was conducted at major medical centers in Texas, Ohio, Oklahoma, California, Illinois, New York, and Florida.

Evolve BioSystems, Inc. Announces the Use of Activated B. infantis EVC001 to Study the Prevention of Type 1 Diabetes in Children

APR 7 2021

Evolve BioSystems, Inc. announced that its product, activated B. infantis EVC001, will be used in one of the largest international clinical studies on preventing type 1 diabetes (T1D) in genetically predisposed children.  The randomized, controlled, double-blind, multicenter trial will be conducted across eight major research centers in five European countries. The Leona M. and Harry B. Helmsley Charitable Trust is funding the study and the continuation of the established newborn screening with more than $30 million. The SINT1A study (Supplementation with B. infantis for Mitigation of Type 1 Diabetes Autoimmunity) aims to show that the daily administration of activated B. infantis EVC001 through the first year of life to children genetically predisposed to T1D will significantly reduce the development of beta-cell autoantibodies in the blood.  Beta-cell autoantibodies are produced by the immune system as part of the process that destroys insulin-producing cells in the pancreas, thus leading to T1D onset early in life. "The prevalence of T1D has grown dramatically over the past 60 years, so the results of this study could have an enormous impact on public health if the increasing incidence of T1D, and its physical, emotional and financial consequences, could be turned back," said Dr. David Kyle, Chief Scientific Officer, Evolve BioSystems, Inc. "We hope to show that a simple intervention of activated B. infantis EVC001 starting in infancy could be life-altering in reducing the prevalence of this autoimmune condition, which would have far-reaching economic and societal benefits." T1D, also known as juvenile diabetes or autoimmune diabetes, can develop in the first years of life, and affects 1.6 million Americans today. It is a lifelong disease for which there is no cure, no means of prevention, and that requires multiple daily insulin injections to manage. Gut inflammation is often caused by an imbalance in the infant gut microbiota in the first few months of life as the result of a deficiency of the key gut bacteria, Bifidobacterium infantis (B. infantis). A substantial body of evidence has connected gut inflammation with improper immune programming and the subsequent development of autoimmune conditions including T1D, atopic dermatitis, food allergies and asthma. A randomized controlled trial in Finland, previously announced in March 2020 by Evolve and in collaboration with Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is underway to assess the impact of activated B. infantis EVC001 on inhibiting the onset of atopic dermatitis in the first year of life. SINT1A is an investigator-initiated, randomized, placebo-controlled, double-blind multi-center intervention study across eight trial sites. Research teams will operate under the direction of renowned T1D researcher Anette-G. Ziegler, Director of the Institute for Diabetes Research at Helmholtz Zentrum München and founding member of GPPAD. "There is a great deal of evidence pointing to the importance of having a healthy gut microbiome in early childhood for preventing immune-mediated diseases like type 1 diabetes," said Dr Ziegler. "By identifying children genetically predisposed to type 1 diabetes early in life and treating their gut imbalances, we could potentially protect them from developing this dangerous and costly disease." The study, among the largest T1D studies to date, will screen approximately 300,000 newborn babies for high genetic predisposition for T1D. Researchers will enroll 1,144 participants.  Within the first six weeks of life through to age 12 months, half of the study participants will receive the dietary intervention of activated B. infantis EVC001 and the other half will receive a placebo. The intervention phase will be followed by observational follow-up every six months up to a maximum age of 6.5 years to assess the presence in the blood of autoantibodies associated with T1D. The study plans to enroll its first patients in April 2021.

Maternal Caffeine Consumption May Reduce Neonatal Size

APR 1 2021

For pregnant women, just half a cup of coffee a day may reduce neonatal birth size and body weight, according to a prospective study involving more than 2,500 women. That’s only 50 mg of a caffeine day, which falls below the upper threshold of 200 mg set by the American College of Obstetricians and Gynecologists, lead author Jessica Gleason, PhD, MPH, of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md, and colleagues reported. “Systematic reviews and meta-analyses have reported that maternal caffeine consumption, even in doses lower than 200 mg, is associated with a higher risk for low birth weight, small for gestational age (SGA), and fetal growth restriction, suggesting there may be no safe amount of caffeine during pregnancy,” the investigators wrote in JAMA Network Open. Findings to date have been inconsistent, with a 2014 meta-analysis reporting contrary or null results in four out of nine studies. Dr Gleason and colleagues suggested that such discrepancies may be caused by uncontrolled confounding factors in some of the studies, such as smoking, as well as the inadequacy of self-reporting, which fails to incorporate variations in caffeine content between beverages, or differences in rates of metabolism between individuals. “To our knowledge, no studies have examined the association between caffeine intake and neonatal anthropometric measures beyond weight, length, and head circumference, and few have analyzed plasma concentrations of caffeine and its metabolites or genetic variations in the rate of metabolism associated with neonatal size,” the investigators wrote. Dr Gleason and colleagues set out to address this knowledge gap with a prospective cohort study, including 2,055 non-smoking women with low risk of birth defects who presented at 12 centers between 2009 and 2013. Mean participant age was 28.3 years and mean body mass index was 23.6. Races and ethnicities were represented almost evenly even across four groups: Hispanic (28.2%), White (27.4%), Black (25.2%), and Asian/Pacific Islander (19.2%). Rate of caffeine metabolism was defined by the single-nucleotide variant rs762551 (CYP1A2*1F), according to which, slightly more women had slow metabolism (52.7%) than fast metabolism (47.3%). Women were enrolled at 8-13 weeks’ gestational age, at which time they underwent interviews and blood draws, allowing for measurement of caffeine and paraxanthine plasma levels, as well as self-reported caffeine consumption during the preceding week. Over the course of six visits, fetal growth was observed via ultrasound. Medical records were used to determine birth weights and neonatal anthropometric measures, including fat and skin fold mass, body length, and circumferences of the thigh, arm, abdomen, and head. Neonatal measurements were compared with plasma levels of caffeine and paraxanthine, both continuously and as quartiles (Q1, ≤ 28.3 ng/mL; Q2, 28.4-157.1 ng/mL; Q3, 157.2-658.8 ng/mL; Q4, > 658.8 ng/mL). Comparisons were also made with self-reported caffeine intake. Women who reported drinking 1-50 mg of caffeine per day had neonates with smaller subscapular skin folds (beta = –0.14 mm; 95% confidence interval, –0.27 to -–0.01 mm), while those who reported more than 50 mg per day had newborns with lower birth weight (beta = –66 g; 95% CI, –121 to –10 g), and smaller circumferences of mid-upper thigh (beta = –0.32 cm; 95% CI, –0.55 to –0.09 cm), anterior thigh skin fold (beta = –0.24 mm; 95% CI, –0.47 to -.01 mm), and mid-upper arm (beta = –0.17 cm; 95% CI, –0.31 to –0.02 cm). Caffeine plasma concentrations supported these findings. Compared with women who had caffeine plasma concentrations in the lowest quartile, those in the highest quartile gave birth to neonates with shorter length (beta = –0.44 cm; P = .04 for trend) and lower body weight (beta = –84.3 g; P = .04 for trend), as well as smaller mid-upper arm circumference (beta = -0.25 cm; P = .02 for trend), mid-upper thigh circumference (beta = –0.29 cm; P = .07 for trend), and head circumference (beta = –0.28 cm; P < .001 for trend). A comparison of lower and upper paraxanthine quartiles revealed the similar trends, as did analyses of continuous measures. “Our results suggest that caffeine consumption during pregnancy, even at levels much lower than the recommended 200 mg per day of caffeine may be associated with decreased fetal growth,” the investigators concluded.

Maternal COVID-19 Vaccination Protects Fetus, Infants, Study Shows

APR 1 2021

Researchers at Massachusetts General Hospital (MGH), Brigham and Women’s Hospital and the Ragon Institute of MGH, MIT and Harvard have found the new mRNA COVID-19 vaccines to be highly effective in producing antibodies against the SARS-CoV-2 virus in pregnant and lactating women. The study also demonstrated the vaccines confer protective immunity to newborns through breast milk and the placenta. The study, published in the American Journal of Obstetrics and Gynecology (AJOG), looked at 131 women of reproductive age (84 pregnant, 31 lactating and 16 non-pregnant), all of whom received one of the two new mRNA vaccines: Pfizer/BioNTech or Moderna. The vaccine-induced titers — or antibody levels — were equivalent in all three groups. Reassuringly, side effects after vaccination were rare and comparable across the study participants. “This news of excellent vaccine efficacy is very encouraging for pregnant and breastfeeding women, who were left out of the initial COVID-19 vaccine trials,” said Andrea Edlow, a maternal-fetal medicine specialist at MGH, director of the Edlow Lab in the Vincent Center for Reproductive Biology and co-senior author of the new study. “Filling in the information gaps with real data is key — especially for our pregnant patients who are at greater risk for complications from COVID-19. This study also highlights how eager pregnant and lactating individuals are to participate in research.” According to the Centers for Disease Control and Prevention, individuals who are pregnant are more likely to become severely ill with COVID-19, require hospitalization, intensive care or ventilation — and may be at increased risk for adverse pregnancy outcomes. The team also compared vaccination-induced antibody levels to those induced by natural infection with COVID-19 in pregnancy, and found significantly higher levels of antibodies from vaccination. Vaccine-generated antibodies were also present in all umbilical cord blood and breast milk samples taken from the study, showing the transfer of antibodies from mothers to newborns.

Injured Purkinje Cells Implicated in Preemies’ Locomotor Learning Deficits

APR 1 2021

Injury to Purkinje cells during fetal and early postnatal life is likely responsible for locomotor learning deficits in very premature infants, researchers say. “Using an animal model of neonatal brain injury that captures the major hallmarks of the injury seen in human newborns, our work uncovers how injury during this early period affects the function of neurons that control adaptive or anticipatory movement, namely the Purkinje cells,” Dr. Aaron Sathyanesan of Children’s National Hospital in Washington, DC said. “The main technical advance in our paper is that we devised a method to monitor the activity of Purkinje cells in animals that were performing a locomotor learning task,” he said. “Since our animal model aims to mimic injury in human newborns, which is often a brain-wide injury, we wanted to know how specific the behavioral changes were to alterations in Purkinje cell function during the early neonatal period,” he explained. “We used a method to artificially silence Purkinje cell firing during the neonatal period in mice that were not exposed to the injury paradigm,” he continued. “The results were quite striking. Both the long-term behavioral measurement and the physiological responses of the Purkinje cells during learning were quite similar to what we observed in animals that were exposed to the injury paradigm.” “This indicates that Purkinje cell activity during the neonatal period is critical for normal behavior in the long-term,” he concluded. Specifically, the researchers measured neural circuit function in the mouse model by pairing GcaMP6f fiber photometry, which measures neuronal activity during movement, with an Erasmus Ladder, which tests motor learning and performance. They introduced obstacles to movement and observed how quickly the mice learned to avoid the obstacle, according to the study published in Proceedings of the National Academy of Sciences of the USA. A series of learning trials plus brain monitoring comparing brain-injured and normal animal models enabled the team to quantify cerebellum-dependent locomotor learning and adaptive behavior. Further, as Dr. Sathyanesan noted, they found that Purkinje cell dysfunction in the brain-injured model specifically interfered with adapted learning, and that switching these cells off (chemogenetic inhibition) in normal models mimicked the effects of perinatal cerebellar injury. The authors state, “Our results uncover a direct link between perinatal cerebellar injury and activity-dependent maturation of cerebellar cortex.”

Preterm Infant Supine Sleep Positioning Becoming More Common

APR 1 2021

Although supine sleep positioning of preterm infants is becoming more common, racial disparities remain, according to a retrospective analysis involving more than 66,000 mothers. Non-Hispanic Black preterm infants were 39%-56% less likely to sleep on their backs than were non-Hispanic White preterm infants, reported lead author Sunah S. Hwang, MD, MPH, of the University Colorado, Aurora, and colleagues. According to the investigators, these findings may explain, in part, why the risk of sudden unexpected infant death (SUID) is more than twofold higher among non-Hispanic Black preterm infants than non-Hispanic White preterm infants. “During the first year of life, one of the most effective and modifiable parental behaviors that may reduce the risk for SUID is adhering to safe infant sleep practices, including supine sleep positioning or back-sleeping,” wrote Dr Hwang and colleagues. The report is in the Journal of Pediatrics. “For the healthy-term population, research on the racial/ethnic disparity in adherence to safe sleep practices is robust, but for preterm infants who are at much higher risk for SUID, less is known.” To address this knowledge gap, the investigators conducted a retrospective study using data from the Pregnancy Risk Assessment Monitoring System (PRAMS), a population-based perinatal surveillance system. The final dataset involved 66,131 mothers who gave birth to preterm infants in 16 states between 2000 and 2015. The sample size was weighted to 1,020,986 mothers. The investigators evaluated annual marginal prevalence of supine sleep positioning among two cohorts: early preterm infants (gestational age less than 34 weeks) and late preterm infants (gestational age 34-36 weeks). The primary outcome was rate of supine sleep positioning, a practice that must have been followed consistently, excluding other positions (i.e. prone or side). Mothers were grouped by race/ethnicity into four categories: non-Hispanic Black, non-Hispanic White, Hispanic, and other. Several other maternal and infant characteristics were recorded, including marital status, maternal age, education, insurance prior to birth, history of previous live birth, insurance, method of delivery, birth weight, and sex. From 2000 to 2015, the overall adjusted odds of supine sleep positioning increased by 8.5% in the early preterm group and 5.2% in the late preterm group. This intergroup difference may be due to disparate levels of in-hospital education, the investigators suggested. “Perhaps the longer NICU hospitalization for early preterm infants compared with late preterm infants affords greater opportunities for parental education and engagement about safe sleep practices,” they wrote. Among early preterm infants, odds percentages increased by 7.3%, 7.7%, and 10.0% for non-Hispanic Black, Hispanic, and non-Hispanic White mothers, respectively. For late preterm infants, respective rates increased by 5.9%, 4.8%, and 5.8% for non-Hispanic Black, Hispanic, and non-Hispanic White mothers. Despite these improvements, racial disparities were still observed. Non-Hispanic Black mothers reported lower rates of supine sleep positioning for both early preterm infants (odds ratio [OR], 0.61; P less than .0001) and late preterm infants (OR, 0.44; P less than .0001) compared with non-Hispanic White mothers. These disparities seem “to be in line with racial/ethnic disparity trends in infant mortality and in SUID rates that have persisted for decades among infants,” the investigators wrote.

Newborns Could Develop Fetal Inflammatory Syndrome From Mothers With COVID-19

APR 1 2021

Throughout the pandemic, doctors have found that pregnant women who contract COVID-19 may be able to pass the infection to their babies. In a new case study, doctors report that newborns could develop a fetal inflammatory response syndrome associated with the virus. In more than 95% of cases, if the mother gets infected, she does well and the baby does well, too. In the case report, pediatricians describe a case of fetal inflammatory response syndrome, or FIRS. The 32-year-old mother, who went into labor prematurely at 34 weeks, showed up at the hospital with COVID-19 symptoms and tested positive for the virus. She also had severe preeclampsia. The baby was delivered quickly and required mechanical ventilation. He had a fever, neonatal respiratory distress syndrome and elevated levels of several inflammatory markers. He tested negative for COVID-19 twice, as well as other infectious diseases. The baby received an antibiotic for seven days and a platelet transfusion for low platelet counts. Ventilation was removed after the fifth day, and he began recovering at the hospital. He was discharged after 22 days with no follow-up required beyond standard prematurity care. FIRS has been documented in premature births, and this case lacked some of the typical abnormalities such as umbilical cord inflammation or placental insufficiency. However, the high inflammatory levels indicated some vascular damage and multi-organ issues, which the authors attribute to exposure to the mother’s COVID-19 infection during pregnancy. The fetal inflammatory response appeared similar to the hyperinflammatory syndrome seen in children during the pandemic, which has been called multisystem inflammatory syndrome in children, or MIS-C. The low platelet counts, in particular, could indicate an inflammatory response associated with COVID-19, the authors write. Several blood and platelet abnormalities have been documented in COVID-19 cases and MIS-C. As the pandemic continues, doctors should monitor platelet counts in newborns with inflammation, the authors suggest, especially if they may have been exposed to COVID-19. In this case, platelet counts stabilized after a transfusion.

Baby Born to Partially Vaccinated Mom Has COVID-19 Antibodies

APR 1 2021

A baby girl born three weeks after her mom got the first dose of Moderna’s COVID-19 vaccine has antibodies against the virus, a February pre-print paper reported. After getting the shot, the mom, a healthcare worker in Florida, developed COVID-19 antibodies. Testing revealed those antibodies passed through the placenta to offer some potential protection to her future child, according to the authors at Florida Atlantic University. While past reports have shown how moms who’ve had COVID-19 can deliver babies with antibodies, the authors believe theirs is the first to record how vaccines during pregnancy may do the same. Authors Dr Paul Gilbert and Dr Chad Rudnick called their report a lucky “opportunity study,” since they were able to find, and follow, a pregnant person who never tested positive for COVID but got the vaccine late in pregnancy and early in the rollout. When the baby — “a vigorous, healthy, full-term girl,” according to the paper — was born, the doctors tested her cord blood for antibodies made from the vaccine, along with conducting other typical tests like for blood type. They were able to detect COVID-19 IgG antibodies (the type that indicate recovery), suggesting the baby has some protection against the virus, though how much or how long it lasts isn’t clear. Future research should illuminate if there’s an ideal time for a pregnant person to get vaccinated to maximize protection against the virus for her child. The authors say their results were expected based on what’s known about how the vaccine, and others recommended during pregnancy like the flu vaccine, work.

Preterm Birth Rate Drops During COVID-19 Pandemic in Tennessee

APR 1 2021

Statewide stay-at-home orders put in place as Tennessee fought to control the spread of coronavirus last March were associated with a 14% lower rate of preterm birth, according to a research letter published today in JAMA Pediatrics. Preterm infants have higher morbidity and mortality risks than babies born at term. Senior author Stephen Patrick, MD, director of the Vanderbilt Center for Child Health Policy and a neonatologist at the Monroe Carell Jr. Children’s Hospital at Vanderbilt, and his colleagues had observed in March that there appeared to be fewer infants than usual in the NICU at the children’s hospital. Along with colleagues at the Tennessee Department of Health and the Centers for Disease Control and Prevention, the team aimed to test if these anecdotal observations were related to the statewide lockdown order. The study is the first in the United States to confirm the trend that more persons staying at home, essentially on forced bed rest, reduced the number of late preterm infants (34-35 weeks). “Preterm birth affects 1-in-10 infants nationwide, taking a substantial toll on children, families and communities,” Patrick said. “Our study, coupled with similar studies from Europe, provide initial evidence that COVID-19 stay at home orders were associated with reductions in spontaneous preterm birth. While encouraging, we need to ensure other pregnancy complications, like stillbirth, did not increase during this time period.” Statewide stay-at-home orders in Tennessee were announced March 22 and expired on April 30. Researchers from Vanderbilt University Medical Center, the Tennessee Department of Health and the CDC collaborated to determine if the odds of pre-term birth during the stay-at-home orders in Tennessee were lower as compared with the same periods in 2015-2019 in Tennessee. There were 49,845 births among Tennessee residents during the study period. The preterm birth rate during the 2020 stay-at-home order was lower than rates in previous years (10.2% vs. 11.3%); late preterm (35-36 weeks gestation) birth rates were also lower (5.8% vs. 6.5%). “The overall decrease in preterm birth we saw during Tennessee COVID-19 stay-at-home order was driven by reductions among infants born late preterm, 35-36 weeks gestation,” said lead author Elizabeth Harvey, PhD, MPH, Maternal and Child Health Epidemiologist at CDC Division of Reproductive Health. “Although we saw less infants born preterm, we also saw infants born during this time required more respiratory assistance at birth, which may suggest they were sicker and warrants further investigation,” she added. Future research could explore whether other US states observed similar reductions, Patrick said, and how obstetric interventions for fetal and maternal complications, or lack thereof, may have contributed.

Hospital Working to Close Health Inequity Gaps

MAR 24 2021

Sinai Chicago's implementation of an EHMD is a result of Illinois House Bill 3509, which was passed and signed into law in 2020, which provides that pasteurized donated human breastmilk and breastmilk-based fortifiers shall be covered under health insurance and the medical assistance program under the Illinois Public Aid Code for premature and at-risk infants. Sinai Chicago is the first system in Illinois to implement both an EHMD and these nutritional  products since the legislation went into effect. “As Chicago’s largest private safety net health system, we serve a high percentage of low-income, minority patients, many of whom are Black women who would not otherwise have access to this standard of neonatal nutrition that their premature infants need to survive and develop,” said Karen Teitelbaum, president and CEO of Sinai Chicago. “We’re addressing this problem head-on by making an EHMD accessible to underserved families.” Proven to reduce complications and improve health, Sinai Chicago will be using nutritional fortifiers that are 100% human milk-based as opposed to cow milk-based. Studies have shown cow milk-based fortifiers can trigger feeding intolerance and increase mortality in premature infants due to the risk of severe complications. When it comes to preterm birth, there are several racial and socioeconomic disparities that need to be addressed. While 1 in 10 babies are born prematurely each year, the preterm birth rate for Black women is 50% higher than for all other women in the U.S., and prematurity is the leading cause of death among Black infants. Premature infants are at an increased risk for problems with the lungs, brain, eyes, and other organs, as well as long-term intellectual and developmental disabilities. “Offering these products as part of an EHMD in our NICU is a monumental step forward for the premature babies born here at Sinai each year,” said Brandee Grenda, clinical nutrition manager at Sinai Chicago. “For these vulnerable babies, access to an EHMD may be the difference between life and death. Not only will this give them the best chance to survive prematurity, but also to go on to thrive as healthy infants, children, and adults.” Premature infants require 20% to 40% more calories and protein than a full-term baby to make up for the growth they missed in the third trimester. To provide this extra nutrition, NICUs often add a fortifier to mother’s own milk or donor breastmilk. However, clinical studies show a direct correlation between the use of cow milk-based fortifiers and the development of devastating, and potentially terminal complications, including necrotizing enterocolitis (NEC), a disease of the intestines. In contrast, preterm infants who receive Prolacta’s products as part of an EHMD, which comprises mother’s own milk and/or donor milk with Prolacta’s 100% human milk-based fortifiers, have fewer complications and better growth outcomes, which have been linked with healthy neurodevelopment in these fragile infants, giving them the best possible chance in life. “The health disparities in the NICU are based on a variety of factors, including race, ethnicity, and income level, among others, and we are committed to ensuring that all premature infants have access to the highest standard of care available,” Teitelbaum said. Sinai Chicago offers high-quality OB/GYN services — including Level III neonatal intensive care and maternity care recognized by the Illinois Perinatal Collaborative for Excellence as well as Blue Cross Blue Shield’s “Blue Distinction” awards — at its north campus located at Mount Sinai Hospital. Its Level III NICU provides the highest level of care available for newborns just steps from the delivery room.

Masimo Monitoring Solutions Promote Newborn and Maternal Safety

MAR 8 2021

Masimo provides a variety of innovative monitoring solutions designed to improve maternal and newborn safety during childbirth and the critical first minutes of life. Masimo SET pulse oximetry’s ability to measure during motion and low perfusion has helped newborns, neonates, and pediatric patients like no other pulse oximetry. Not only has Masimo SET helped clinicians reduce retinopathy of prematurity (ROP) and improve screening for critical congenital heart disease (CCHD), but it has helped push the standard of care for babies to new heights—the evidence from CCHD studies with SET, for example, has been used in the establishment of screening guidelines used around the world. On International Women’s Day, it is especially important to recognize that, as UNICEF reports, “newborns and mothers are still dying in appalling numbers.” Every day, approximately 7,000 babies in the first month of life die, and approximately 810 women die, from preventable complications related to childbirth or pregnancy. Similarly, according to the WHO, “Although important progress has been made in the last two decades, about 295,000 women died during and following pregnancy and childbirth in 2017. The most common direct causes of maternal injury and death are excessive blood loss, infection, high blood pressure, unsafe abortion, and obstructed labor, as well as indirect causes such as anemia, malaria, and heart disease.” Masimo’s first and ongoing focus has been helping neonatologists, pediatricians, OB-GYNs, and midwives around the world provide the best care possible for newborns and their mothers. The Masimo Newborn Sensor, the first and still the only sensor of its kind, was introduced in 2004 and is designed to provide accurate arterial oxygen saturation (SpO2) and pulse rate (PR) measurements in the fastest time possible during hectic neonatal resuscitation scenarios. Alongside Newborn Sensors, Pathway, introduced in 2019 for the Root platform, helps clinicians visualize their preferred SpO2 and PR protocol during neonatal resuscitation. Eve, a software application introduced in 2014, simplifies and automates the CCHD screening process, which Masimo SET enabled. The Blue Sensor, introduced in 2004, provides accurate monitoring in cyanotic children at low SpO2 levels to help clinicians care for them and was validated specifically on infants with cyanotic disease. rainbow SpHb, noninvasive hemoglobin monitoring, introduced in 2008, can measure hemoglobin levels during pregnancy and alert clinicians to the possibility of excessive blood loss during delivery. Adding to the significant body of clinical evidence demonstrating the utility of SET pulse oximetry and other Masimo newborn and maternal solutions, a new study published in the Journal of Clinical Neonatology investigated the use of comparing Masimo perfusion index (Pi) pre- and post-ductal values on pre-term infants to aid clinicians in diagnosing hemodynamically significant patent ductus arteriosus (hsPDA). Dr Melek Büyükeren and colleagues at Hacettepe University in Ankara, Turkey found that the difference in right-hand and right-leg Pi values obtained using Masimo SET pulse oximetry was significantly higher in pre-term infants with hsPDA, leading them to conclude that the difference in Pi “has diagnostic value in hsPDA and can assist diagnosis when echocardiography is not available.” Marcelo Cardetti, MD, said, “As Head of the Neonatology Service of the Clinic and Maternity of the Center for Endocrinology and Human Reproduction (CERHU) in San Luis, Argentina, we have been using Masimo pulse oximetry monitors with SE for approximately 8 years in all high-risk newborns and also for newborn resuscitation. In addition, we use Masimo SET monitors for the detection of CHD and hypoxemia in all newborns in the mother-infant unit. Furthermore, our neonatal department is engaged in a research protocol on regional cerebral oxygenation (O3) with neonatal sensors for Masimo Root - to know what happens with cerebral oxygenation during routine clinical procedures in the NICU. This monitoring, in addition to SpO2 and perfusion index (Pi), perfectly shows us what is happening with oxygenation of seriously ill newborns in real-time and in a noninvasive way. Masimo SET’s innovative technology far overcomes the limitations of conventional oximetry and the Pi is an important clinical tool in the care of sick neonates. This monitor and the special neonatal RD sensors have been of great value for the prevention of ROP and for successful and quick, accurate, and reliable steps needed in resuscitation in the delivery room.” Hernando Baquero, MD, commented, “I am a pediatrician, neonatologist, clinician, educator and researcher in a major university in Colombia, with several publications on noninvasive neonatal SpO2 monitoring and oxygenation. The introduction in the Latin American market of Masimo SET technology dramatically improved neonatal care in our countries. In contexts with serious resource limitations, as is the case in most neonatal units in our countries, it was vital to be able to provide quality care to the most vulnerable population due to their health conditions (e.g. hypoperfusion) or their biological characteristics (e.g. prematurity). Having reliable, fast, and stable readings as provided by SET and its neonatal sensors improved the chances of many of our newborns.” Anne de-Wahl Granelli, PhD, Biomedical Scientist, RDCS(PE), Medical Centre Manager, Sweden, said, “The integration of pulse oximetry into the CCHD screening process has made a significant impact on the detection of congenital heart disease and neonatal health. In clinical studies, the use of pulse oximetry screening with SET technology significantly improved the detection of duct dependent heart disease before hospital discharge. In 2011, the U.S. Department of Health and Human Services added pulse oximetry screening of newborns for CCHD to the Recommended Uniform Screening Panel. Today pulse oximetry has become a global standard of care when screening newborns for CHD.” Sergio Golombek, MD, MPH, FAAP, Member of the Board and Past President of the Ibero-American Society of Neonatology (SIBEN), said, “I have authored and published several scientific studies in relation to newborn oxygenation and screening for CCHD. Masimo SET and new innovations and sensor development like RD sensors for noninvasive monitoring represent excellent technology that we can trust, that work promptly and accurately when we need it the most, and are designed specifically with ill newborn babies in the NICU in mind. SET technology allows us also to do the pulse oximetry test or CCHD screening on newborn babies in our units, knowing well that we can fully trust the results. The technology is very easy to use and understand, and makes us deliver better clinical care.” Katsuyuki Miyasaka, MD, PhD, Executive Advisor, Wayo Women’s University Graduate School, Tokyo and Professor Emeritus, St. Luke’s International University, Tokyo, said, “As a critical care pediatric anesthesiologist, reliable and accurate pulse oximetry is paramount to optimal patient outcomes. Some suggest pulse oximetry is the fifth vital sign. Clinicians can rely on the sensitivity and specificity provided by Masimo’s measure-through-motion technology in the management of children in the PICU. The use of pulse oximetry can lead to fewer adverse events in the recovery room by capturing accurate readings even during movement such as shivering in critically ill or unstable patients.” Mark Ansermino, MBBCh, MMed, Director of the Center for International Child Health and Professor, Department of Anesthesiology, Pharmacology & Therapeutics at the University of British Columbia, Canada, said, “Anemia is a significant public health problem that especially affects the quality of life, health status, and survival of mothers and children around the world. Having access to continuous hemoglobin monitoring technology can help provide visibility to hemoglobin levels. The noninvasive nature of the SpHb solution makes it comfortable for the mother and child and makes monitoring during childbirth feasible even in low-resource settings.” Asrat Dibaba Tolossa, MD, MPH, is Chief of Party for the Global Affairs Canada ENRICH (Enhancing Nutrition Services to Improve Maternal and Child Health) Program, a multi-year, multi-country initiative designed to improve the health and nutrition of mothers, newborns, and children. As part of the program, ENRICH has been conducting a study in central Tanzania, where maternal and child care services are often overburdened, using the Masimo Rad-67 Pulse CO-Oximeter, which provides spot-check SpHb measurements. Dr. Tolossa commented, “In our field experimentation with the Rad-67, we found out that the device can be used easily by lower-level health workers in the communities for screening and referral of patients to health facilities for further assessment and treatment. There was also a high acceptance rate by community members as the method is noninvasive.” Joe Kiani, Founder and CEO of Masimo, said, “From our inception, we have been committed to improving outcomes for the youngest and most fragile patients. Our foundational SET pulse oximetry was designed with newborns in mind. With rainbow Pulse CO-Oximetry, we have made the noninvasive monitoring of child and mother clinically more meaningful. While we stand behind the fact that we have the best pulse oximetry for all patients, especially the most fragile patients, we continue to seek new ways to help clinicians provide newborns and their mothers with the best care possible. On this International Women’s Day, we thank the caregivers who have dedicated themselves to the health of newborns and their mothers, as well as women everywhere, for their achievements, their sacrifices, and for nurturing us all.” SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples. Noninvasive, continuous SpHb has CE clearance for all patients and in the U.S. has received FDA clearance for patients >3 kg but is not currently indicated for patients <3 kg. As part of its U.S. FDA 510(k) clearance, spot-check SpHb on Rad-67 is contraindicated for use on pregnant patients and not indicated for use on pediatric patients or patients with renal disease. Eve has not obtained FDA clearance and is not available in the United States.

New Study in Newborns Finds Nellcor Pulse Oximetry Technology Provides Fast Stable Oxygen Saturation Readings

FEB 9 2021

Medtronic announced the results of an independent, prospective observational study comparing the efficacy and reliability of two pulse oximeters — Nellcor Bedside SpO2 Patient Monitoring System and Masimo Radical-7 Pulse CO-Oximeter, both set at the highest sensitivity ("Neonatal" and "Fast" for Nellcor pulse oximetry technology and "Max" for Masimo) — with electrocardiography (ECG) monitoring following the delivery of 60 term newborns by Caesarian section. Pulse oximetry is a simple, noninvasive bedside test that can accurately detect the percentage of blood saturated with oxygen and measure heart rate. According to the study, a stable signal was obtained from all 60 newborns with the Nellcor pulse oximeter but from only 55 newborns with the Masimo pulse oximeter. Of the 55 newborns with stable signals from both monitors, the mean time to stable signal with the Nellcor pulse oximeter was 15 seconds compared with 27 seconds with the Masimo pulse oximeter. The average difference of 12 seconds between the monitors was statistically significant (P <0.001). The results of this prospective observational comparative study were published online in the Journal of Perinatology, the official journal of the Section on Neonatal-Perinatal Medicine of the American Academy of Pediatrics and the Neonatal-Perinatal Association of the United States. The study was conducted at the Rabin Medical Center, Petach Tikvah, Israel, a university-affiliated tertiary care center with approximately 9,000 births annually. The principal investigator of the study is Professor Ruben Bromiker, MD, Department of Neonatology, Schneider Children's Medical Center of Israel, Petach Tikvah, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. The availability of a pulse oximeter for monitoring oxygenation and heart rate of newborns contributes to decision making during resuscitation and stabilization, and can help physicians minimize the risk of either too low or too high blood oxygen levels and associated morbidity and mortality, the authors state in the discussion section. Both the Nellcor and Masimo pulse oximeters provide relatively quick measurements of oxygen saturation and heart rate in most cases well before the so-called "golden first minute" of resuscitation. The results conclude that Nellcor showed a statistically significant difference in the time needed to deliver a stable signal between devices which could potentially impact the provision of care during neonatal resuscitation. With respect to heart rate, the study observed there was a difference of 12 beats per minute (BPM) between the Masimo monitor and the reference standard ECG in 18 of 51 (35%) newborns. In all 18 newborns, the ECG showed a heart rate >100 BPM versus <100 BPM with the Masimo monitor, which may be observed as false bradycardia with the Masimo device. In 16 of the 51 (31%) newborns, the difference in heart rate with the Masimo monitor was 40 BPM compared with the rate recorded by the comparator ECG. In contrast, the heart rate detected by the Nellcor pulse oximetry monitor correlated closely with that of the ECG, with no recording of false bradycardia and no reading having >40 BPM difference compared with the ECG. "A newborn's heart rate is a key component of physician assessment for resuscitation, and helps to identify not only those in need of intervention but also their response to treatment. Those who do not achieve a heart rate of 100 beats per minute by five minutes of life are at an increased risk of death," said Frank Chan, president, Patient Monitoring, which is reported as part of the Minimally Invasive Therapies Group at Medtronic. "This study demonstrates that physicians can rely on Nellcor pulse oximetry technology to post data quickly, offer consistency, perform well with these patients, and meet the requirements of the neonatal resuscitation program guidelines, which are especially important in the delivery room." These findings are important because, per the neonatal resuscitation program (NRP) guidelines, only one minute should be allotted for completing the initial monitoring steps to inform reevaluation and initiation of ventilation.

New NeoSmile Plus Temperature Probe Cover Available

JAN 29 2021

Neotech Products announces the NeoSmile Plus Temperature Probe Cover is now available. Unlike our original NeoSmile that uses hydrocolloid for long-lasting adhesion, NeoSmile Plus features a silicone gel base. The unique, skin friendly gel allows for the temp prob cover to be repositioned with ease. “Ever since being introduced to silicone adhesives we searched for the right product to implement it. We knew that temp probe covers could be a challenge, but wanted to bring something unique to the market. We started to work with silicone adhesives for this, thus resulting in the creation of the NeoSmile Plus,” said Sara Dimmitt, Manager of Business Development. The new NeoSmile Plus is a skin friendly option that can be moved or adjusted as needed. Yet, it securely holds the probe in place for reliable readings. The reflective foil cover helps protect the temperature probe from ambient and radiant heat in an incubator, and the foam layer provides added insulation. Various test users stated: “Easier to move; a more accurate reading than our current product.” “Sticks better than our old one and it’s smaller.” “I like the thin, low profile.” “Very impressed with this product.”

Maternal COVID Antibodies Cross Placenta, Detected in Newborns

JAN 29 2021

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented at the virtual Society for Maternal-Fetal Medicine (SMFM) 2021 Annual Pregnancy Meeting. "I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection," Naima Joseph, MD, MPH, of the Emory University School of Medicine, Atlanta, Georgia, said. "Our data demonstrate maternal capacity to mount an appropriate and robust immune response," and maternal protective immunity lasted at least 28 days after infection, Joseph said. "Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates." The researchers analyzed the amount of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein. The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days. All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies. "It's reassuring that so far, the physiological response is exactly what we expected it to be," Judette Louis, MD, MPH, an associate professor of ob/gyn and the ob/gyn department chair at the University of South Florida, Tampa, Florida, said. "It's what we would expect, but it's always helpful to have more data to support that. Otherwise, you're extrapolating from what you know from other conditions," said Louis, who moderated the oral abstracts session. Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

New Tool Helps Predict Preterm Birth, Neonatal Problems

JAN 29 2021

Progesterone metabolites in plasma coupled with patient factors can help identify pregnant women at risk for preterm delivery and neonatal morbidity, researchers report. This research "breaks new ground," by demonstrating that 11-deoxycorticosterone (DOC) and 16-alpha-hydroxyprogesterone (16-alpha-OHP) in plasma can predict the extent of preterm delivery-associated neonatal morbidity and length of neonatal hospitalization when measured early in pregnancy, Dr. Avinash Patil of the University of Arizona College of Medicine in Phoenix said. "Previously, much of the research in obstetrics focused purely on predicting gestational age at delivery as a surrogate (estimate) for neonatal outcomes," he said. "The findings of this research are particularly applicable to value-based healthcare models, which are increasingly prevalent for maternity care. The ability to screen a population of pregnancies and identify those at risk for poor neonatal outcomes can decrease healthcare costs while improving the health of newborns." An imbalance of progesterone metabolism has been linked to an increased risk of preterm delivery. In a prior study, Dr Patil and his colleagues found that DOC and 16-alpha-OHP, when measured during the late first trimester/early second trimester, can predict a woman's risk for spontaneous preterm delivery prior to 32 weeks. In the new study in PLOS ONE, they set out to determine if obstetric and demographic variables known during the pregnancy, when combined with these steroid-metabolite biomarkers obtained early in pregnancy, could predict the risk of preterm-delivery-associated neonatal morbidity in a low-risk population of pregnant women. The researchers quantified the two progesterone metabolites using mass spectroscopy from plasma of 58 pregnant women collected in the late first trimester or early second trimester. They combined the steroid-level data with patient demographic and obstetric history data in multivariable logistic regression models. Forty of the pregnant women delivered preterm (<37 weeks) and 18 delivered at term (greater than or equal to 37 weeks). Ten women had elevated Hassan scores of 2 or higher, with the remaining 48 had scores of zero to one. Women delivering babies with an elevated Hassan score of two to four were more likely to have a higher BMI and deliver at a lower gestational age than peers delivering babies with a low Hassan score. Neonates with an elevated Hassan score were born at a lower gestational age and birthweight, were more likely to receive antenatal corticosteroids, have a lower five-minute Apgar score, and require resuscitative measures at birth compared to babies with a low Hassan score. The final neonatal morbidity model, which incorporated antenatal corticosteroid exposure and fetal sex, was able to predict high morbidity (a Hassan scale score of 2 or higher) with an area under the ROC curve (AUROC) of 0.975, with an optimal sensitivity of 90% and specificity of 96%. The final model characteristics included a positive predictive value (PPV) of 0.82 and negative predictive value (NPV) of 0.98. With the addition of the two biomarkers to the final model, the positive likelihood ratio for neonatal morbidity as measured with a Hassan Score of two to four was 21.6 (95% confidence interval, 5.48 to 85.21) for women with a positive test result. Newborns of women who screened positive with the model had significantly longer median length of hospital stays compared with newborns of women who screened negative (53 days vs. 4.5 days; P=0.0017). The researchers caution that this "discovery work and findings need to be validated in an independent cohort before we can fully implicate the changes in these biomarkers with preterm birth and neonatal morbidity." "The test is not yet clinic ready," Dr Patil said. "Steps that remain include validation of the results and meeting federal guidelines for development of new tests. The biomarkers in the study are very promising, so we are pushing forward to accomplish these milestones and make a new test reality.

Labor Induction at 39 Weeks May Improve Neonatal Outcomes

JAN 29 2021

Labor induction at 39 weeks instead of 41 weeks may have a positive impact on neonatal outcomes, Aaron B. Caughey, MD, PhD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. For much of the 20th century, term gestation has been defined as 37 weeks and beyond, said Caughey, of Oregon Health & Science University, Portland. He noted several studies showing a U-shaped distribution in neonatal outcomes during the period from 37 weeks to 41 weeks for some outcomes, including Apgar scores. However, respiratory outcomes in a study from 2008 showed an increase, with meconium stained amniotic fluid increasing from 2.27% at 37 weeks to 10.33% at 41 weeks, and meconium aspiration increasing from 0.07% at 37 weeks to 0.27% at 41 weeks. The study "that really got everyone's attention" in terms of neonatal outcomes was published in 2009 in the New England Journal of Medicine. The cohort study included 24,077 elective cesarean deliveries between 37 and 42 weeks and reviewed a range of neonatal outcomes based on gestational age. The rate of any adverse outcome decreased from 37 weeks to 39 weeks, "but then started going back up again," Caughey said. He reviewed data from another study that factored in stillbirth and the risk of expectant management based on gestational age. A composite risk of perinatal death with expectant management was 15.4 deaths per 10,000 cases at 37 weeks and 39 weeks, but increased to 19.9 at 42 weeks. "The morbidity appears to have a U-shaped distribution and the mortality seems to favor delivery at 39 weeks," he said. When it comes to induction of labor, medically indicated vs. nonmedically indicated does matter, Caughey said. Factors not considered a medical indication include impending macrosomia, increased risk for developing preeclampsia or intrauterine growth retardation, and a favorable cervix, he noted. "For indicated induction of labor, the risks and benefits of induction of labor vs. expectant management have been considered and weighed in by the field of experts that care for pregnant women," he said. With nonmedically indicated induction, experts "either decided that risks and benefits don't favor induction of labor, or we haven't come down hard on what the protocol might be. "It is important to consider the risks and benefits," said Caughey. The factors you want to include are neonatal outcomes, maternal preferences, and doctor preferences. However, "we want to be thoughtful about this intervention," because of the association of higher costs and increased risk of cesarean with induction of labor. As for timing of induction of labor, certain conditions favoring early-term induction include preeclampsia and gestational hypertension, chronic hypertension, diabetes, intrauterine growth restriction, nonreassuring fetal testing, cholestasis, placenta previa or accreta, and twins. As for late-term induction of labor, "at 41 weeks it is pretty clear that neonatal outcomes would be improved by delivery," he said. Historically, clinicians have raised concerns about the increased risk of cesarean delivery following induction of labor, but this risk has not been borne out in recent studies. Caughey said. However, in the findings from the ARRIVE trial, a large study of 6,106 women who were randomized to induction or labor or expectant management at 39 weeks, "they found a reduction in their risk of cesarean delivery compared to expectant management (18.6% vs. 22.2%). Rates of preeclampsia also were lower among induced women, while rate of chorioamnionitis, postpartum hemorrhage, and intensive care were similar between the groups. The researchers did not find significant differences in perinatal outcomes.

Russian Woman United With Baby After COVID-19 C-section and 51 Days on Life Support

JAN 15 2021

A Russian woman who was admitted to hospital heavily pregnant and with what doctors said were potentially fatal levels of COVID-19 lung damage was reunited with her newborn baby after spending 51 days on a ventilator and giving birth by C-section. Oksana Shelomentseva was hospitalised in the Siberian city of Irkutsk in the 32nd week of her pregnancy, having had a high fever for three days. A scan showed catastrophic lung damage and that her unborn baby was not receiving enough oxygen. “My temperature rose to 38 degrees Celsius and I battled with it for three days, but it became clear I could not do that independently,” Shelomentseva said. Doctors immediately performed a Caesarean section to deliver baby girl Liza, but still feared for the recovery of the mother who went on to spend almost two months on a ventilator to help her breathe. “It was a very serious case,” said Galina Shkandriy, head of the Anaesthesiology and Intensive Care Department at the hospital where Shelomentseva was treated. “The entire ward is to thank for the patient recovering from 100% lung damage,” the RIA news agency cited her as saying. “When we consulted doctors from around the city, they all said ‘you probably won’t be able to do anything because with those indicators, people don’t survive.’” “Oksana spent 51 days in intensive care in a most serious condition. We were able to save her from the most severe lung damage and multiple organ failure,” said Shkandriy. Shelomentseva was discharged on Monday and returned home to her husband and three children, including baby Liza. At 3,448,203, Russia has the world’s fourth-largest tally of coronavirus cases after the United States, India and Brazil, and has reported 62,804 deaths from the virus.

Newborns Benefit From Skin-to-Skin Contact With Father After C-Section

JAN 15 2021

There is an undeniable amount of research on the natural benefits of skin-to-skin contact for mum and baby. Essentially, skin-to-skin contact is simply that, babies’ skin against their parents’ skin immediately after birth and continuing later at home. It naturally regulates a new-born’s temperature, heart rate and breathing while elevating their blood sugar which is essential for energy. It also encourages breastfeeding and colonises the baby’s natural gut bacteria to that of its mother, making their intestinal bacteria more diverse, protecting them from illness and infection. Skin-to-skin is not just reserved for mum, however. It is vitally important that dad also partakes in this ancient art of snuggling with their new-born. In fact, this close contact with dad brings about many of the same remarkable benefits as it does with mum. Being warm and snug in your arms, is your new-born’s favourite place to be. They often cry less, sleep better and are more content when warm against your skin. Be that mum or dads. The benefits of skin-to-skin with dad are not always advertised as strongly as they are with mum considering an important facet of this connection is establishing breastfeeding. But when a father has the opportunity to hold their baby close, skin-to-skin, we see the love hormone, oxytocin, doing exactly what it needs to — creating the natural bond between parent and child and helping you to fall in love with them. This is the same hormone that makes a woman’s uterus contract in labour. Research has also shown skin-to-skin helps to develop more caring behaviour in dad and also a more sensitive approach to parenting. Furthermore, it has been shown to decrease cortisol levels in new dads which is greatly linked to anxiety. Less stress and less anxiety have a direct positive, correlation on the parent’s relationship which naturally affects the family dynamic.

Labor Induction at 41 Weeks Tied to Lower Morbidity, Mortality Than Expectant Management

JAN 15 2021

Inducing labor at 41 weeks may result in a lower risk of severe adverse perinatal and neonatal outcomes than expectant management until 42 weeks, a systematic review and meta-analysis of randomized clinical trials in PLOS Medicine suggests. Researchers examined data from three clinical trials with a total of 5,161 low-risk singleton pregnancies. They assessed a composite primary outcome of perinatal mortality, including stillbirth or neonatal mortality within 28 days of birth, and neonatal morbidity including: five-minute Apgar score below 4, hypoxic ischemic encephalopathy, intracranial hemorrhage, neonatal convulsions, respiratory distress, mechanical ventilation within 72 hours of birth, and obstetric brachial plexus injury. The analysis included individual data for 4,561 participants, including 2,281 women scheduled for labor induction at 41 weeks; four in five of these women ultimately had the scheduled induction and the rest delivered spontaneously. Among 2,280 women assigned to expectant management until 42 weeks, about 30% needed induction and the rest delivered spontaneously. In the induction group, 10 cases (0.4%) met the composite primary endpoint of perinatal death or severe neonatal morbidity; 23 cases (1.0%) occurred in the expectant management group. "The take home messages is that induction of labor will decrease the risk of adverse perinatal outcome, including mortality, without increasing the morbidity risk for the woman including cesarean delivery, perineal laceration grade III-IV and postpartum hemorrhage — especially in nulliparous women," said lead study author Dr Marten Alkmark of the University of Gothenburg in Sweden. "For parous women the risk of adverse perinatal outcome is very low with both induction of labor and expectant management," Dr Alkmark said by email. Among nulliparous women, the risk of the primary outcome was lower among those in the induction group (0.03%) than in the expectant management group (1.6%). However, the risk of the primary outcome among multiparous women was similar with induction (0.6%) and expectant management (0.3%). None of the women in the study had a history of cesarean delivery or other major uterine surgery, and all of them had low-risk singleton pregnancies with the fetus in cephalic position. Researchers also looked at perinatal secondary outcomes and found there was only one perinatal death in the induction group, a stillbirth that occurred after randomization but before induction. Seven of the eight perinatal deaths in the expectant management group were stillbirths, while one infant died because of hypoxic ischemic encephalopathy. Limitations of the analysis include the relatively small size of the study compared with other reviews of induction versus expectant management, as well as some heterogeneity in how the two trials included in the analysis defined some endpoints. "The risk of perinatal death and severe neonatal morbidity increases gradually after 41 weeks of pregnancy, probably linked to the placenta deteriorating," said Sara Kenyon, a professor of evidence based maternity care at the University of Birmingham in the U.K. who wasn't involved in the study. "However, it wasn't clear when the optimal time to induce women is and this study suggests that, particularly for nulliparous women, that this is 41 weeks," Kenyon said by email.

Supplemental Oxygen During Childbirth May Not Be of Value to Babies

JAN 15 2021

Babies who suffer oxygen deficiencies during birth are at risk of brain damage that can lead to developmental delays, cerebral palsy and even death. To prevent this, most women in labor undergo continuous monitoring of the baby's heart rate and receive supplemental oxygen if the heart rate is abnormal, with the thought that this common practice increases oxygen delivery to the baby. However, there is conflicting evidence about whether the long-recommended practice improves infant health. Now, a comprehensive analysis — led by Washington University School of Medicine in St. Louis - looking at 16 previous trials of the practice has found no benefit in providing supplemental oxygen to mothers during labor and delivery. Infants born to women who received supplemental oxygen fared no better or no worse than those born to women who had similar labor experiences but breathed room air. Each year, 1.5 million women in the U.S. — two out of three pregnant women — receive supplemental oxygen at some point during childbirth, according to the researchers. The decades-long practice is recommended by the American College of Obstetricians and Gynecologists to treat abnormal fetal heart rates, which may indicate the baby's oxygen levels are low and pose health risks. Raghuraman added that supplemental oxygen is given mostly as a preventive measure, a practice that began during the 1960s. "Fetal monitoring can indicate a possible abnormal issue such as oxygen deprivation," she said. "But about 80% of the time, women giving birth fall into an intermediate category, in which cases are not completely benign but also not high-risk. And in cases such as these, supplementing oxygen offers no additional benefits." For the analysis, the researchers examined 16 studies published from 1982 through 2020 of randomized controlled trials in humans — including one from School of Medicine researchers — involving more than 2,052 women in childbirth. "Overall, the studies produced mixed results, with some indicating a benefit and others indicating no benefit," Raghuraman said. "That was the reason for doing a meta-analysis. By pooling the numbers of patients across the studies we could get a more definitive answer than looking at individual studies." The researchers evaluated the pH levels of the babies' blood from samples taken shortly after birth. The pH measures the body's acidity and alkalinity in blood and other fluids, with neutral equaling pH value of 7. For infants, Raghuraman said anything less than 7.1 is considered abnormal and indicates oxygen deprivation. The researchers also compared neonatal intensive care admission rates and Apgar scores — a well-established test to evaluate newborn health at one and five minutes after birth. Apgar scores check a baby's heart rate, breathing and other signs to determine if the baby needs additional medical care. "Comparing the health of the babies whose mothers received oxygen and those whose mothers didn't, we found that the differences were essentially zero," Raghuraman said.

Breastfeeding, Rooming-in Can Be Practiced by Mothers With SARS-CoV-2

JAN 15 2021

For women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, rooming-in and breastfeeding are feasible for those who can care for their infants, with postnatal transmission occurring infrequently, according to a study published online Dec. 7 in JAMA Pediatrics. Andrea Ronchi, M.D., from the Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico in Milan, and colleagues examined the risk for postnatal transmission of SARS-CoV-2 from infected mothers to their neonates following rooming-in and breastfeeding in a prospective, multicenter study involving mother-infant dyads followed up for 20 days of life. Participants included 62 neonates born to 61 mothers with SARS-CoV-2 infection who were eligible for rooming-in based on their clinical condition and negative infant nasopharyngeal swab result at birth. The researchers found that only one infant (1.6 percent) was diagnosed as having SARS-CoV-2 infection at postnatal checks. In that case, due to severe worsening of the mother's clinical condition, rooming-in was interrupted on day 5 of life. On day 7 of life, the neonate became positive for the virus and developed transient mild dyspnea. Almost all (95 percent) neonates were breastfed. "We believe that SARS-CoV-2-infected mothers in good clinical condition and willing to take care of their babies should be encouraged to practice rooming-in and breastfeeding after being carefully instructed about the appropriate droplet and contact precautions," the authors write.