News

Breastfeeding Safe for Mothers With COVID-19 Infection

04/15/2021

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

04/15/2021

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

04/15/2021

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

04/15/2021

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

04/15/2021

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

04/07/2021

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

04/07/2021

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

04/01/2021

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

04/01/2021

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

04/01/2021

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

04/01/2021

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

04/01/2021

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

04/01/2021

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

04/01/2021

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

03/24/2021

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

03/08/2021

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

02/09/2021

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

01/29/21

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

01/29/21

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

01/29/21

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

01/29/21

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

01/15/2021

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

01/15/2021

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

01/15/2021

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

01/15/2021

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

01/15/2021

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.

Pasteurizing breast milk inactivates SARS-CoV-2 virus

12/30/2020

Researchers at the University of Toronto and Sinai Health have found that a common technique to pasteurize breast milk inactivates the virus that causes COVID-19, making it safe for use. It's the first time the impact of pasteurization on coronaviruses in human milk has been reported in the scientific literature and the findings provide assurance for parents and families who use human milk banks to feed their infants. Current advice is for women with COVID-19 to continue to breastfeed their own infants and it is standard care in Canada to provide pasteurized breast milk to very-low-birth-weight babies in hospital until their own mother's milk supply is adequate. “In the event that a woman who is COVID-19-positive donates human milk that contains SARS-CoV-2, whether by transmission through the mammary gland or by contamination through respiratory droplets, skin, breast pumps and milk containers, this method of pasteurization renders milk safe for consumption,” the authors write in their study, published in the Canadian Medical Association Journal. The lead author on the paper was Sharon Unger, a professor of paediatrics and nutritional sciences at U of T and neonatologist at Sinai Health, who is medical director of the Rogers Hixon Ontario Human Milk Bank. Unger said the current pandemic is a time for extra efforts to protect the supply of donated human milk, in part because formula was scarce and previous pandemics — notably HIV/AIDS — created major challenges for human milk bank supply. The Holder method, a technique used to pasteurize milk in all Canadian milk banks (62.5°C for 30 minutes), is effective at neutralizing viruses such as HIV, hepatitis and others that are known to be transmitted through human milk. In this study, researchers spiked human breast milk with a viral load of SARS-CoV-2 in U of T’s combined containment level three unit and tested samples that either sat at room temperature for 30 minutes or were warmed to 62.5°C for 30 minutes. The virus in the pasteurized milk was inactivated after heating.

Effectiveness of Antibiotics for Cesarean Section Births

12/30/2020

Antibiotics for cesarean section births are just as effective when they're given after the umbilical cord is clamped as before clamping — the current practice — and could benefit newborns' developing microbiomes, according to Rutgers co-authored research. The study, by far the largest of its kind and published in the journal Antimicrobial Resistance & Infection Control, challenges current recommendations for antibiotic use. Administering antibiotics after clamping does not increase the risk of infection at the site of C-section incisions, the study concludes. "Most national and international guidelines, including those of the World Health Organization, recommend that women receive antibiotics before the skin incision for cesarean section," said co-author Maria Gloria Dominguez-Bello, Henry Rutgers Professor of Microbiome and Health, professor of microbiology and anthropology, and director of the New Jersey Institute for Food, Nutrition, and Health in the School of Environmental and Biological Sciences at Rutgers University-New Brunswick. "That exposes the baby to antibiotics during birth, affecting the microbiome assembly in the newborn. Early disturbance of bacterial colonization and the developing healthy microbiome may have consequences for immune development, leading to immune malfunctions later in life." A healthy microbiome helps guard against infection and antibiotics disrupt the microbiome, wiping out both bad and good bacteria, according to the U.S. Centers for Disease Control and Prevention. Even stressors perceived as small, such as a hospital birth, can affect the neonatal microbiome, as shown by Dominguez-Bello's group in a 2018 study, and perturbations of the microbiome in early life possibly affect development of immunity and metabolism. Administering antibiotics to prevent infections of the surgical site is common practice and justified to minimize risks. But for cesarean section, the impact of antibiotics on the newborn and its developing microbiome should be considered, as well as the risk of infection, Dominguez-Bello said. Giving mothers antibiotics after clamping avoids additional stressors that impair transmission and colonization of maternal microbes after birth, so the current recommendation for antibiotics before clamping should be revised. The study, led by Rami Sommerstein at Bern University Hospital in Switzerland, covered 55,901 women at 75 hospitals in Switzerland from 2009 to 2018. They include 26,405 patients who received antibiotics before skin incisions for C-sections and 29,496 patients after their umbilical cords were clamped. Of the 846 documented infections after C-sections, 379 (1.6 percent) occurred in women who received antibiotics before incisions and 449 (1.7 percent) occurred in those who received antibiotics after their umbilical cords were clamped, with no statistical differences. "That means receiving antibiotics after umbilical cords are clamped to protect against maternal infections is as effective as receiving them before incisions," Dominguez-Bello said. "The guidance on the best timing for antibiotic use should be reevaluated to help promote the development of a healthy microbiome, which is essential for normal immune system development in babies. Bypassing the birth canal is already a stressor that should not be aggravated by the effect of antibiotics in the newborn."

Pregnancy After Breast Cancer Is Rockier But Doesn't Increase Recurrence Risk

12/30/2020

Breast cancer survivors are less likely to get pregnant and have higher risks of some delivery and fetal complications, according to a meta-analysis reported at the 2020 San Antonio Breast Cancer Symposium. However, the data also showed that pregnancy does not increase the risk of cancer recurrence. “With the availability of more effective anticancer treatments, survivorship and addressing the treatments’ potential long-term toxicities has gained substantial attention,” said study investigator Matteo Lambertini, MD, PhD, of University of Genova (Italy) — IRCCS Policlinico San Martino Hospital. “Returning to a normal life after cancer diagnosis and treatment should be considered, in the 21st century, as a crucial ambition in cancer care,” Dr Lambertini added. “In patients diagnosed during their reproductive years, this includes the possibility to complete their family planning. Due to the constant rise in age at first pregnancy over the past years, many women are diagnosed with breast cancer before completing their reproductive plans.” In that context, certain cancer treatments have the potential to reduce fertility. In addition, many women need prolonged hormone therapy, and conception is contraindicated while they are receiving it. Dr Lambertini and colleagues performed a meta-analysis using data from 39 studies that included a total of 114,573 breast cancer patients and 8,093,401 women from the general population. Results showed that breast cancer survivors were much less likely than women in the general population to become pregnant (relative risk, 0.40; P < .001). However, “the majority of the studies included in our meta-analysis did not capture the information on how many women tried to get pregnant,” Dr Lambertini cautioned. In the few studies that did, more than half of women trying to conceive did become pregnant, and most of them were able to do so naturally, without need for assisted reproductive technologies. On the flip side, analyses also showed that pregnancies occurred in some women who did not want to conceive, underscoring the importance of comprehensive oncofertility counseling that addresses not only fertility preservation, but also contraception, Dr Lambertini said. Among women who became pregnant, breast cancer survivors did not have higher odds of spontaneous abortion or complications such as preeclampsia, and their infants were not significantly more likely to have congenital abnormalities. However, the breast cancer survivor group did have higher odds of cesarean birth (odds ratio, 1.14; P = .007), low birth weight (OR, 1.50; P < .001), preterm birth (OR, 1.45; P = .006), and infants small for gestational age (OR, 1.16; P = .039). In stratified analysis, the higher risk of having an infant with low birth weight was significant only for women who had received chemotherapy, and the higher risk of having an infant small for gestational age was significant only for women who had received chemotherapy or who had a late pregnancy (more than 2 years to 5 years after cancer diagnosis). Among breast cancer survivors, those who became pregnant actually had lower risks of disease-free survival events (hazard ratio, 0.73; P = .016) and death (HR, 0.56; P < .001). Findings were similar in the subset of studies that adjusted for the so-called healthy mother effect.

Inventing Therapies that Save Lives

10/29/2020

Swedish-Canadian researcher Christer Sinderby is the man behind Getinge’s patented Neurally Adjusted Ventilatory Assist (NAVA). Using the patient’s own respiratory drive to control ventilator assistance, NAVA has elevated mechanical ventilation to an entirely new level and helped the tiniest premature baby in the world survive. “We are talking about the ECG of breathing,” Christer says. “Using NAVA in mechanical ventilation is like adding ECG to a stethoscope when monitoring a heart. Both are based on electrical signals and more precise.” The blowing of air has powered most of Christer Sinderby’s life. In his youth, the talent for mastering the mighty sea breezes enabled him to compete with the best windsurfers in the world. As a scientist, the ability to control a few milliliters of air blown into a premature baby’s tiny lungs has earned him and his wife Jennifer Beck respect in the entire medical world. Recently, NAVA played a major role in helping a premature baby in Japan, weighing only 258 grams at birth, survive. “It goes without saying that it is hard to sync a ventilator with rapid breaths of only 2-3 milliliters of air. We have managed to use the baby’s own respiratory drive to achieve this synchronization,” Christer explains. “The beauty of NAVA is that it can help all types of patients breathe; no matter if it is a tiny premature baby weighing a few hundred grams or an overweight 90-year old.” NAVA has been used exclusively by Getinge since it was invented in the mid-1990s. Since 2003, Christer Sinderby is a scientist at the Keenan Research Centre for Biomedical Science, University of Toronto, Canada. “In principle, NAVA connects the patient’s brain to the ventilator,” Christer says. “The device uses the same electrical signal that activates the diaphragm to control the rhythm, depth and duration of our breathing. This means that the ventilator continuously is fully synchronized with the patient´s own breathing efforts.” The electrical discharge of the diaphragm is captured by a special Edi catheter; placed in the esophagus and also functions as a gastric feeding tube. “Since it is the patient’s own physiological signal that control the tidal volume and respiratory pattern, NAVA promotes lung-protective spontaneous breathing and reduces the risk of blowing to much or too little air into the lungs. NAVA simply delivers what the patient wants.” Christer adds: “With traditional mechanical ventilation it is often easier to ‘shut down’ an uncomfortable patient with sedation than to finetune the ventilator to deliver the right tidal volume and frequency. This is what we want to avoid.” Independent of air leakages, NAVA also facilitates non-invasive ventilation with nasal masks or prongs. A much more comfortable alternative than intubating the patient. Back in 1999, the innovation of NAVA was so remarkable that it was published in the prestigious Nature Medicine. “I think we are still the only researchers focusing on ventilator technology published there,” Christer says. Christer Sinderby and Jennifer Beck are still dedicated to improve the abilities of Getinge’s mechanical ventilators. “We focus on ventilation solutions that will be a reality in 5-10 years. Getinge’s patience with the long-term scope that is a necessity in medical research has paved the way for a partnership with mutual respect for the corporate and scientific perspectives,” Christer concludes.

Company Earns Another Ventilation Industry Award

10/21/2020

Dräger, an international leader in the fields of medical and safety technology, announced that Frost & Sullivan has recognized the company as a global technology innovation leader in the ventilation industry. Frost & Sullivan selected Dräger for its 2020 Global Technology Innovation Leadership Award due to the company’s pioneering work to enhance patient safety and expedite recovery through innovative ventilator clinical protocols, continuous improvements in ventilation technology, and best-in-class services/support, training and continuing education. Furthermore, Dräger has significantly increased its ventilator production in 2020 to address the spike in demand driven by COVID-19. The COVID-19 pandemic has highlighted the essential need for ventilation in the treatment of critically ill patients, as well as the adverse events caused by the misuse of mechanical ventilators. During the pandemic, Frost & Sullivan analysts have been observing how the deployment of different types of ventilator models impact patient care. “We are honored to have been chosen by Frost & Sullivan for this prestigious award,” said President and CEO for Dräger in North America, Lothar Thielen. “We would not be where we are today without our employees’ dedication to continuous improvement in technology and services, and the support of our customers in helping us address their changing needs. Whether it is the ongoing challenges of value-based care, or the immediate needs presented by the current pandemic, we are proud to stand as a trusted partner to healthcare providers and their patients.” Frost & Sullivan acknowledged Dräger in the following areas: Ventilator technology: “Compared to other competitors’ products, Dräger’s Evita ventilator models offer superior technology benefits for both patient safety and user flexibility.” This includes invasive and non-invasive ventilation modes, advanced technologies that support lung protection and early weaning, and secured connectivity with other devices; service and support: “Dräger offers comprehensive and best-in-class services for healthcare providers with respect to ventilation along with digital solutions for connected care and data insights, which many competitors are striving to match.” This includes device maintenance, IT consulting and system integration, user training, and network-based services and analysis of device data; COVID-19: “Dräger has upheld its guiding principle ‘Technology for Life’ during the COVID-19 pandemic, helping countries around the world to maintain the functionality of critical infrastructure as well as ensuring that the demand for ventilators is met across the globe by significantly increasing its production.” Through its Intensive Care Online Network (ICON) emergency program, Dräger had made its ventilators available to hospitals in “hot spot” areas, along with online continuing education and a 24/7 real-time support. This is the third time in three consecutive evaluation cycles that Frost & Sullivan has recognized Dräger for best practices in ventilation therapy. In 2017, Dräger won the Frost & Sullivan North American Medical Ventilation Product Leadership Award, and in 2014 the Frost & Sullivan Best Practices Award in the Growth Excellence Leadership category for Mechanical Ventilation Equipment.

Augusto Sola, MD, Receives Pioneer Award

10/19/2020

Masimo announced that Augusto Sola, MD, Vice President of Medical Affairs for Neonatology at Masimo, has been awarded the 2020 Pioneer Award, Section of Neonatal Perinatal Medicine, by the American Academy of Pediatrics (AAP). The honor recognizes the groundbreaking achievements and contributions Dr Sola has made, using his Masimo SET-based protocol, to improve the health and well-being of newborn infants. Sola's impressive career in neonatology has improved the lives of countless newborns in the US, Latin America, and across the world. Dr Sola's innovative research on oxygen administration and monitoring oxygen saturation in preterm infants has played a key role in reducing the rate of neonatal blindness (retinopathy of prematurity) and our understanding of the impact of various neonatal practices on the developing brain. Dr Sola has published 130 original articles in peer-reviewed journals, 390 review articles, and 5 neonatology textbooks, as well as delivered more than 3,500 lectures to research and clinical groups around the world. Dr Sola also founded the Ibero-American Society of Neonatology (SIBEN), dedicated to continuous quality improvement in neonatal care throughout the Americas. Sola received his MD at Buenos Aires University School of Medicine and completed his Pediatric Residency and Chief Pediatric Residency at the University of Massachusetts, followed by a Neonatal Fellowship at the University of California, San Francisco. In neonatal practice since 1974, Dr Sola has been Professor of Pediatrics at Buenos Aires University Medical School, the University of California, San Francisco, the University of California, Los Angeles, and Emory University. In addition to his position at Masimo, Dr Sola continues to work directly with critically ill newborns. Sola’s seminal work was done in 1998 at Cedars-Sinai Medical Center in Los Angeles. The results, published in 2003 by Drs Sola, Wright, and Chow, showed that using a new protocol with Masimo SET, clinicians reduced ROP to nearly zero over five years. Dr Sola and colleagues later showed at Emory that the protocol's success depended on SET technology, as the same protocol with a competing pulse oximeter did not reduce ROP. Dr Sola’s work on the reduction of ROP through oxygen saturation targeting has now become the standard of care. Dr Sergio Golombek, MD, MPH, Professor of Pediatrics at New York Medical College, Neonatologist, Ex-President of SIBEN, and AAP member, commented, "In 1952, a Chicago newspaper wrote: 'The best friend a baby ever had,' referring to pediatrician Isaac A Abt, MD, FAAP (1867-1955), founder of the AAP and its first president in 1930. He was known as a leading clinician, academic, advocate, promoter, writer, and leader. I think this has been overcome by Dr Sola, who is, in my opinion, the best friend of a baby and his or her parents and of the many neonatal professionals and trainees whom he trained!" Joe Kiani, Founder and CEO of Masimo, said, "We are incredibly proud of Dr Sola, a brilliant and caring doctor whom I have had the privilege of knowing for many years. Dr Sola's pioneering work on the oxygen saturation of neonates has made a significant impact on the prevention of blindness in infants, and his contributions to our understanding of neonatal physiology are vast. It is only fitting that the American Academy of Pediatrics has chosen to honor him. We are grateful to benefit from his expertise at Masimo, which has been especially dedicated, ever since its founding, to improving outcomes for the youngest and most fragile patients. Congratulations, Dr Sola, on this well-deserved recognition."

Born too early with a 50/50 chance of survival — now she helps save other premature babies

10/06/2020

When Sabina Checketts holds her hand a certain way, the tiny scar on the back of it looks like a rocket ship. Checketts got the scar during the first few days of her life, during a tenuous struggle for survival, after she was born at 28 weeks—12 weeks prematurely. Her rocket ship scar, and a few other small ones, are marks left by lines inserted into her tiny, frail body to keep her alive. "I don't point these out to parents," Checketts says, "but to me they're badges of honor, because I survived." The parents she's referring to are the parents of her patients. Thirty-three years after her early birth, Checketts now works as a neonatal doctor in London. Checketts decided to become a doctor at early age, when her mother routinely pointed out a man walking down the street on his way to the hospital and said, “That’s the doctor who saved your life”. That experience motivates her to be a source of positivity for the families of the babies she treats. "When I talk to parents about the fact that I was premature, there always is a sense of surprise, I think a little bit even shock, you know. Oh, oh, and you're a doctor," Checketts says. "I think it's a nice way to say to them that prematurity shouldn't be a limit on what a child can do.” "I mean, the advances we've made in even just the last 10, 15, 20 years mean the outcomes are much better than they used to be. And seeing me, who developed before that, as a newborn doctor, I give them a sense of hope and possibility, I think." Today, she uses vastly improved technologies and techniques to create better outcomes for other premature babies—and more hope for their parents. As vulnerable premature babies fight to stay alive one of the most critical issues is something most people never think twice about—breathing. A pivotal advance in neonatal medicine—and one that has a major impact in adult critical care—has been the development of better ventilators. "One of the main challenges for premature babies is with ventilation," says Checketts. "Their lungs are quite stiff when they're first born because they're so immature. They're very fragile." The ventilator that helped Checketts survive was a far cry from what she sees today when she treats premature babies. "We've gone from a mode of ventilation where you were breathing for the baby to one now where we can breathe with the baby as well," she says. One ventilation technique that breathes with the patient is called Neurally Adjusted Ventilatory Assist, or NAVA, developed by Getinge, a global leader in intensive care technology for both infants and adults. Before NAVA, ventilation technology had advanced to the point that a sensor in the breathing tube alerted when a baby was trying to breathe in, and the machine supplied a breath. But there was lag time, resulting in the machine sometimes not supplying air when the lungs called for it, or forcing air into frail lungs that were not ready for it—a problem amplified by premature babies' tendency to take short, rapid and uneven breaths. Sherry Courtney, a director of clinical research in neonatology, who has worked with premature babies since the 1980's explains, "The diaphragm is a muscle. When it contracts, we're going to breathe. When it relaxes, we're going to exhale. So, NAVA senses the breathing using a catheter that goes down into the stomach and rests close to the diaphragm." Courtney says she's observed many babies who switch to a NAVA-enabled ventilator almost immediately become more comfortable and less irritable. Their oxygen needs decrease, as do pressure and volume requirements. Babies can be more restful and concentrate energy on the single most important thing they can do during their premature stage-grow. "We have been switching in our unit more and more to NAVA because the babies seem to love it," Courtney says. NAVA is also approved for adults, and the features that make the technique successful for neonates translate well to adult patients. Adults on ventilators generally start with a functioning diaphragm, but it becomes weaker quickly. Getinge’s Medical Director Miray Kärnekull says that advanced ventilator technologies like NAVA are used regularly in adult patients in Europe to keep patients' diaphragm muscles active. “It’s really a groundbreaking technology”, says Kärnekull. “NAVA gives the clinician a way to personalize not only the ventilation, but also the weaning process for adult patients”. And in a very recent multicenter randomized controlled trial, results showed that patients with acute respiratory failure on NAVA spent significantly less time on the ventilator and experienced less extubation failure compared to conventional lung-protective mechanical ventilation.

Device Maker Adds to its Team

09/30/2020

Mercury Medical, a medical device manufacturer focused on airway and respiratory healthcare markets, announces the appointment of Raymond L. Mundy to the newly created position, Executive Vice President – Sales and Marketing. Mundy will be responsible for the continued sales growth of Mercury’s products throughout the United States and the global marketplace. “We are excited to have Ray join the company at a time when, more than ever, the treatment of respiratory disease demands innovative new products and solutions. Ray is a 17-year veteran in our industry, with a diverse clinical and commercial background bringing a wealth of sales and operations expertise to our Company,” said CEO, John Gargaro, MD. Mundy joins Mercury from Medtronic plc including companies that were subsequently acquired by the firm, such as Covidien during his tenure. “I am very pleased to be joining Mercury Medical as their new Executive Vice President of Sales and Marketing. The opportunities that exist both at the company and the markets they serve are tremendous. There has never been a more critical time to ensure access to Mercury’s respiratory and airway management technologies,” said Mundy. Mercury Medical is a global provider of airway and respiratory medical device systems for healthcare providers bringing a legacy of innovation, high quality lower cost solutions, and better patient outcomes. The company distributes its products into 58 countries, into critical care, neonatal, anesthesia and EMS markets.

Ventilation Technology Breaks Ground for Adults and Premature Babies

09/30/2020

Born 12 weeks too early with a 50/50 chance at survival, Sabina Checketts has grown up to become a neonatal doctor herself, using new therapies and sophisticated technology to improve outcomes for premature babies. One such technique called NAVA, invented by Getinge, utilizes sensors to help babies on ventilators breathe more easily and naturally—and it's increasingly being used on adults. And a new randomized study shows that NAVA can significantly shorten the time on the ventilator. Thirty-three years after her early birth, Checketts now works as a neonatal doctor in London. The ventilator that helped Checketts survive was a far cry from what she sees today when she treats premature babies. "We've gone from a mode of ventilation where you were breathing for the baby to one now where we can breathe with the baby as well," she says. As vulnerable premature babies fight to stay alive one of the most critical issues is something most people never think twice about - breathing. A pivotal advance in neonatal medicine—and one that has a major impact in adult critical care—has been the development of better ventilators. One ventilation technique that breathes with the patient is called Neurally Adjusted Ventilatory Assist, or NAVA, developed by Getinge, a global leader in intensive care technology for both infants and adults. In most intensive care units 20% of patients consume 80% of ventilation resources, which may lead to increased complications and unwanted outcomes. NAVA, is also approved for adults, and the features that make the technique successful for neonates, translates well to adult patients. "NAVA is a way to do a little better job," says Sherry Courtney, a director of clinical research in neonatology, who has worked with premature babies since the 1980's. "The diaphragm is a muscle. When it contracts, we're going to breathe. When it relaxes, we're going to exhale. So, NAVA senses the breathing using a catheter that goes down into the stomach and rests close to the diaphragm." Electrodes on the catheter sense contractions in the diaphragm, resulting in an almost instantaneous signal that the patient wants to breathe. Synchronously, the ventilator supplies air. And when the electrodes sense the end of diaphragmatic contractions, the ventilator allows exhalation. "NAVA just provides a little support, depending on the breath the patient can be breathing as the patient wishes," says Courtney. Adults on ventilators generally start with a functioning diaphragm, but it will quickly become weaker if a machine breathes for them for too long. Getinge Medical Director Miray Kärnekull says that advanced ventilator technologies, like NAVA, are used regularly in adult patients in Europe to keep patients' diaphragm muscles active. And in a very recent multicenter randomized controlled trial, results showed that patients with acute respiratory failure on NAVA spent significantly less time on the ventilator and experienced less extubation failure compared to conventional lung-protective mechanical ventilation. “In addition to helping maintain the diaphragm's tone, the synchrony of a NAVA ventilator means patients don't fight against the ventilator,” Miray Kärnekull continues. “To prevent that, adults usually need to be sedated. With NAVA, doctors can reduce sedatives, allowing for earlier weaning with fewer complications … It’s really a groundbreaking technology”, says Kärnekull. “NAVA gives the clinician a way to personalize not only the ventilation, but also the weaning process for adult patients.” These exciting advances have allowed physicians like Checketts to celebrate even more success stories. Checketts decided to become a doctor at early age, when her mother routinely pointed out a man walking down the street on his way to the hospital and said, “That’s the doctor who saved your life.” That experience motivates her to be a positive force in the families of the babies she treats. "When I talk to parents about the fact that I was premature, there's always a sense of surprise, I think a little bit even shock, you know. Oh, oh, and you're a doctor," Checketts says. "I think it's a nice way to say to them that prematurity shouldn't be a limit on what a child can do. I mean, the advances we've made in even just the last 10, 15, 20 years mean the outcomes are much better than they used to be. And seeing me, who developed before that, as a newborn doctor, I give them a sense of hope and possibility, I think."  

The Benefits of Human Milk Detailed in Meta-analysis

09/16/2020

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, announced the results of a new meta-analysis involving more than 450 very low birth weight (VLBW) premature infants. The report, published in Neonatology Today, found those fed a diet of human milk had a lower risk of complications and/or death when Prolacta’s 100% human milk-based fortifiers were added to mother’s own milk or donor human milk rather than cow milk-based fortifiers. To support the rapid growth that takes place during their first weeks of life, very preterm infants typically require a nutritional fortifier added to their feeds to provide the calories and protein they need. There are two kinds of fortifiers available: cow milk-based and Prolacta’s 100% human milk-based. Numerous studies have demonstrated that VLBW infants fed cow milk-based products, rather than human milk-based fortifiers, may have a greater risk of adverse outcomes, including late-onset sepsis, bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) and mortality. However, few studies have directly compared outcomes of the use of cow milk-based versus human milk-based fortifiers among VLBW infants fed a base diet of human milk (as opposed to cow milk-based formula or a combination of the two). To address this question using as much of the available evidence as possible, Lucas et al. gathered data from three studies, including two prospective, randomized clinical trials, and compared outcomes of 453 preterm infants fed a base diet of mother’s or donor milk and fortified with Prolacta’s fortifiers or cow’s milk-derived fortifier (CMDF). Meta-analyses of data from the three studies showed that when compared with the Prolacta human milk-derived fortifier (HMDF) group, the CMDF group was associated with: 40% higher risk of a positive mortality/morbidity index in the CMDF group (RR = 1.4; P = 0.006), when the same index from the O’Connor et al. study10 was applied to the combined meta-analysis; 2.4-fold higher risk for retinopathy of prematurity (ROP) (RR = 2.4; P = 0.001); 3.3-fold higher risk for NEC (RR = 3.3; P = 0.008). “These findings provide additional evidence that adding a cow milk-based fortifier to mother’s or donor milk not only reduces the health benefits of that milk, but increases the risk of complications and mortality,” said Melinda Elliott, MD, chief medical officer of Prolacta. “In contrast, nurturing these vulnerable infants with an exclusive human milk diet that includes Prolacta’s 100% human milk-based fortifiers not only increases their odds of survival, but also reduces the risk of the most serious complications. Human milk for human babies just makes sense.”

Revision Urged to Guidelines on Caffeine in Pregnancy

08/29/2020

Doctors should advise pregnant women and women planning to become pregnant to abstain completely from caffeine, according to a new narrative review in BMJ Evidence Based Medicine. "For the wellbeing of mothers and babies, health authorities are well-overdue to take a more realistic and responsible position in relation to maternal caffeine consumption," the report's author, Professor Jack E. James of Reykjavik University in Iceland, said in an email. "In short, caffeine should be avoided altogether during pregnancy." The American College of Obstetricians and Gynecologists (ACOG) and several other health authorities state that moderate consumption of caffeine in pregnancy is not harmful, with some, including ACOG, defining this amount as less than 200mg daily. In the UK, "Based on current scientific opinion, the Food Standards Agency (FSA) advises pregnant and breast-feeding women not to have more than 200mg of caffeine over the course of a day, which is roughly two mugs of instant coffee or one mug of filter coffee," the FSA said. The US Department of Agriculture (USDA) defers to physicians in its 2015-2020 Dietary Guidelines for Americans, stating: "Women who are capable of becoming pregnant or who are trying to, or who are pregnant, and those who are breastfeeding should consult their health care providers for advice concerning caffeine consumption." Eighty-two percent of pregnant women in the US, and 91% in France, report consuming caffeine daily, James notes in his report. Caffeine easily crosses the placenta, he added, and is known to affect neural processes, including brain networks that control respiration and heart function. He analyzed 48 observational studies and meta-analyses of maternal caffeine consumption reporting at least one of six negative outcomes: miscarriage; stillbirth, low birthweight/small for gestational age; preterm birth; childhood acute leukemia and childhood overweight and obesity. Thirty-seven observational studies reported 42 separate findings, including 32 showing increased risk of harm due to caffeine in all outcomes except preterm birth, while 10 didn't find an association or were inconclusive. Out of 17 meta-analyses, 14 found associations between caffeine and miscarriage, stillbirth, low birth weight and/or small for gestational age and childhood acute leukemia. "Certainly, there is no evidence to suggest that caffeine benefits either mother or baby. Therefore, even if the evidence were merely suggestive, and in reality it is much stronger than that, the case for recommending caffeine be avoided during pregnancy is thoroughly compelling," James said. "It is important for the public to understand that caffeine is not the benign substance it is often portrayed to be. Unfortunately, the position of many health authorities to date has been disappointing in this regard," he added. "The idea that there is a safe level of maternal caffeine consumption is a myth that is strongly at odds with the scientific evidence. This accepting attitude towards caffeine and pregnancy must change." In an emailed statement, ACOG said that it does not plan to change its guidelines at present. "Our guidance remains that moderate caffeine consumption, less than 200 mg per day, does not appear to be a major contributing factor in miscarriage or preterm birth," Dr Christopher Zahn, MD, ACOG's vice president of Practice Activities, said. "ACOG's clinical guidance is based on a thorough expert review of the most current evidence and is routinely reviewed every 18-24 months. ACOG Committee Opinion, 'Moderate Caffeine Consumption During Pregnancy' was reaffirmed this year," he added. "While this study will likely be included in the next review, there is nothing that warrants immediate change to the current guidance."

Black Newborns Less Likely to Die When the Treating Physician Is Also Black

08/29/2020

While research has shown that Black newborns in the US die at three times the rate of white newborns, a new study suggests that those numbers might improve when the race of the physician is concordant with the child's. Based on data from 1.8 million births between 1992 and 2015, researchers found the in-hospital death rate among Black newborns was one third lower when these babies were treated by a Black physician, rather than a white one, according to the results published in the Proceedings of the National Academy of Sciences. The research doesn't hold the key to why concordance might be beneficial to Black infants, said study coauthor Rachel Hardeman, Blue Cross Endowed Professor of Health and Racial Equity at the University of Minnesota-Twin Cites School of Public Health, in Minneapolis. "That's the million-dollar question," Hardeman said. "What we know from previous research is that there are issues around racism and implicit bias and that when physicians are short on time or in stressful situations, they are much more likely to rely on implicit biases." To take a closer look at whether patient-physician concordance could make a difference in Black newborn survival, Hardeman and her colleagues modeled data from the State of Florida's Agency for Healthcare Administration, which provides a census of patients admitted to Florida hospitals. Those data include detailed information on both the mother and the newborn, including race; comorbidities; outcomes; and the name, specialty certifications, and date of licensure of the treating physician. While the database did not include the physician's race, the researchers determined that from publicly available photos.For their analysis, the researchers only included data on Black and white newborns and Black and white physicians. Overall, they found the raw mortality rate for white newborns was 289 per 100,000 births, while the raw mortality rate for Black newborns was 784 per 100,000 births. When the researchers analyzed newborn death rates by race of treating physician, they found that under the care of a white physician, Black newborns experienced 430 more fatalities per 100,000 births than white newborns. Under the care of Black physicians there was a big difference: there were 173 more fatalities per 100,000 births among Black newborns compared to white newborns. That's a difference of 257 deaths per 100,000, the authors note.

When the researchers looked specifically at white newborns treated by white physicians, they did not find a similar benefit from concordance. Ultimately, the researchers determined that the "mortality penalty" for Black newborns is 39% lower under the care of a Black physician than under a white physician.

Federal Investigation Finds Hospital Violated Patients' Rights

08/29/2020

A prominent women's hospital here violated patients' rights by singling out pregnant Native American women for COVID-19 testing and separating them from their newborns without adequate consent until test results became available, according to a federal investigation disclosed to New Mexico In Depth and ProPublica. Lovelace Women's Hospital did not admit to any wrongdoing but reported that the practice has been halted. Hospital officials submitted a plan to fix problems identified by investigators, including a promise to conduct internal audits to ensure compliance with state and federal regulations and COVID-19 screening guidance. "The Department of Health will assure that the plan of correction is fully and effectively enacted," said New Mexico Secretary of Health Kathyleen Kunkel, the state's highest-ranking public health official. "The Division of Health Improvement will be conducting an unannounced onsite survey to verify compliance." Investigators with the state Health Department, who are contracted to conduct site surveys for the US Centers for Medicare and Medicaid Services, or CMS, launched their inquiry after an article by New Mexico In Depth and ProPublica reported that the hospital had targeted Native American mothers for COVID-19 testing based on their tribal-area ZIP codes, then separated them from their newborns while awaiting test results. All patients were screened upon arrival at the hospital with forehead temperature checks and standard questionnaires. But starting in late April, according to the report, patients with home ZIP codes on the hospital's list were treated as "persons under investigation" and tested for COVID-19. That practice stopped May 28, investigators were told — one week after New Mexico In Depth and ProPublica first approached a hospital official about newborns being separated from Native American mothers. The practice, while meant to stop the spread of COVID-19, was described by clinicians and health care ethicists as racial profiling. Isolating expectant mothers as though they had the virus created a stressful birth experience, a clinician noted. Separating newborns from mothers awaiting lab test results denied them early skin-to-skin contact and breastfeeding, which studies have shown can affect bonding. Investigators concluded that the hospital failed to protect patients' rights by implementing an "informal policy to target patients that live on Native American reservations for COVID testing, and [to] separate mother and baby while test results were pending, and did not provide clear options for these patients to request or refuse COVID testing and separation from their babies."

Webinar: Investigating Gut Health and the Microbiome of Premature Babies

08/27/2020

Health professionals are invited to take part in a webinar called Building a Better Baby Biome: Caring for our Babies and their Bugs. Featured Speaker: Dr Katherine Gregory. The event is Thursday, September 17 at 11 a.m. ET. During this webinar, Dr Katherine Gregory will discuss:

• Intestinal biology during early life
• The relationships between microbes and host cells
• Clinical factors that impact the establishment of the intestinal microbiome early in life
• Child health outcomes that are influenced by gut health and the intestinal microbiome
• Opportunities to therapeutically manipulate the intestinal microbiome to improve health outcomes

Registration and Complete Event Details: https://bit.ly/3gv8Ctz

Webinar: Obtain High Quality Hearing Screening Results in the Shortest Possible Time

08/25/2020

The Webinar on Newborn Hearing Screening is free and takes place on September 15, 12:00 pm (CST). Presented by: Kathy Murphy, MA, Newborn Screening Product Manager, MAICO Diagnostics, you’ll learn to explain why early identification of congenital hearing loss is important; name the two techniques used to screen newborns for hearing loss; describe the basic physiology of the auditory system’s response to the two screening methods; identify at least two environmental conditions that can make hearing screening challenging and ways to control them; explain the role of baby state on the hearing screening process; and list at least two “tips & tricks” to employ to achieve high quality screening results in the shortest time. Registration link: https://register.gotowebinar.com/register/9161613977261770507

Small NY Study: Mother-Baby Transmission of COVID-19 Not Seen

08/17/2020

All infants born to a cohort of 31 COVID-19–positive mothers tested negative for the virus during the height of the New York surge, according to a study out of New York-Presbyterian Hospital. "It is suggested in the cumulative data that the virus does not confer additional risk to the fetus during labor or during the early postnatal period in both preterm and term infants," concluded Jeffrey Perlman, MB ChB, and colleagues in Pediatrics. But other experts suggest substantial gaps remain in our understanding of maternal transmission of SARS-CoV-2. "Much more needs to be known," Munish Gupta, MD, and colleagues from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, said in an accompanying editorial. The prospective study is the first to describe a cohort of U.S. COVID-19–related deliveries, with the prior neonatal impact of COVID-19 "almost exclusively" reported from China, noted the authors. They included a cohort of 326 women who were tested for SARS-CoV-2 on admission to labor and delivery at New York-Presbyterian Hospital between March 22 and April 15th, 2020. Of the 31 (10%) mothers who tested positive, 15 (48%) were asymptomatic and 16 (52%) were symptomatic. Two babies were born prematurely (one by Cesarean) and were isolated in negative pressure rooms with continuous positive airway pressure. Both were moved out of isolation after two negative test results and "have exhibited an unremarkable clinical course," the authors reported. The other 29 term babies were cared for in their mothers' rooms, with breastfeeding allowed, if desired. These babies and their mothers were discharged from the hospital between 24 and 48 hours after delivery. "Visitor restriction for mothers who were positive for COVID-19 included 14 days of no visitation from the start of symptoms," noted the team. They added "since the prepublication release there have been a total of 47 mothers positive for COVID-19, resulting in 47 infants; 4 have been admitted to neonatal intensive care. In addition, 32 other infants have been tested for a variety of indications within the unit. All infants test results have been negative." The brief report outlined the institution's checklist for delivery preparedness in either the operating room or labor delivery room, including personal protective equipment, resuscitation, transportation to the neonatal intensive care unit, and early postresuscitation care. "Suspected or confirmed COVID-19 alone in an otherwise uncomplicated pregnancy is not an indication for the resuscitation team or the neonatal fellow," they noted, adding delivery room preparation and management should include contact precautions. "With scrupulous attention to infectious precautions, horizontal viral transmission should be minimized," they advised.

Parental Refusal of Neonatal Therapy a Growing Problem

08/17/2020

Parents who refuse one indicated neonatal preventive therapy often refuse others even when the reasons are different, according to an update at the Pediatric Hospital Medicine 2020 Virtual. This finding indicates the value of preparing policies and strategies to guide parents to appropriate medical decisions in advance. "Elimination of nonmedical exceptions to vaccinations and intramuscular vitamin K made it into two of the AAP [American Academy of Pediatrics] top 10 public health resolutions, most likely because refusal rates are going up," reported Ha N. Nguyen, MD, of the division of pediatric hospital medicine at Stanford (Calif.) University. Importantly, state laws differ. For example, erythromycin ointment is mandated in neonates for prevention of gonococcal ophthalmia neonatorum in many states, including New York, where it can be administered without consent, according to Nguyen. Conversely, California does not mandate this preventive therapy even though the law does not offer medico-legal protection to providers if it is not given. "There is a glaring gap in the way the [California] law was written," said Nguyen, who used this as an example of why protocols and strategies to reduce risk of parental refusal of neonatal therapies should be informed by, and consistent with, state laws. Because of the low levels of vitamin K in infants, the rate of bleeding within the first few months of life is nearly 2%, according to figures cited by Nguyen. It falls to less than 0.001% with administration of intramuscular vitamin K. Families who refuse intramuscular vitamin K often state that they understand the risks, but data from a survey Nguyen cited found this is not necessarily true. In this survey, about two-thirds knew that bleeding was the risk, but less than 20% understood bleeding risks included intracranial hemorrhage, and less than 10% were aware that there was potential for a fatal outcome. "This is a huge piece of the puzzle for counseling," Nguyen said. "The discussion with parents should explicitly involve the explanation that the risks include brain bleeds and death." Although most infant bleeds attributed to low vitamin K stores are mucocutaneous or gastrointestinal, intracranial hemorrhage does occur, and these outcomes can be devastating. Up to 25% of infants who experience an intracranial hemorrhage die, while 60% of those who survive have some degree of neurodevelopmental impairment, according to Nguyen. Oral vitamin K, which requires multiple doses, is not an appropriate substitute for the recommended single injection of the intramuscular formulation. The one study that compared intramuscular and oral vitamin K did not prove equivalence, and no oral vitamin K products have been approved by the Food and Drug Administration, Nguyen reported. "We do know confidently that oral vitamin K does often result in poor adherence," she said.

Parental Refusal of Neonatal Therapy a Growing Problem

07/30/2020

Parents who refuse one indicated neonatal preventive therapy often refuse others even when the reasons are different, according to an update at the Pediatric Hospital Medicine 2020 Virtual. This finding indicates the value of preparing policies and strategies to guide parents to appropriate medical decisions in advance. "Elimination of nonmedical exceptions to vaccinations and intramuscular vitamin K made it into two of the AAP [American Academy of Pediatrics] top 10 public health resolutions, most likely because refusal rates are going up," reported Ha N. Nguyen, MD, of the division of pediatric hospital medicine at Stanford (Calif.) University. Importantly, state laws differ. For example, erythromycin ointment is mandated in neonates for prevention of gonococcal ophthalmia neonatorum in many states, including New York, where it can be administered without consent, according to Nguyen. Conversely, California does not mandate this preventive therapy even though the law does not offer medico-legal protection to providers if it is not given. "There is a glaring gap in the way the [California] law was written," said Dr. Nguyen, who used this as an example of why protocols and strategies to reduce risk of parental refusal of neonatal therapies should be informed by, and consistent with, state laws. Because of the low levels of vitamin K in infants, the rate of bleeding within the first few months of life is nearly 2%, according to figures cited by Nguyen. It falls to less than 0.001% with administration of intramuscular vitamin K. Families who refuse intramuscular vitamin K often state that they understand the risks, but data from a survey Nguyen cited found this is not necessarily true. In this survey, about two-thirds knew that bleeding was the risk, but less than 20% understood bleeding risks included intracranial hemorrhage, and less than 10% were aware that there was potential for a fatal outcome. "This is a huge piece of the puzzle for counseling," Nguyen said. "The discussion with parents should explicitly involve the explanation that the risks include brain bleeds and death." Although most infant bleeds attributed to low vitamin K stores are mucocutaneous or gastrointestinal, intracranial hemorrhage does occur, and these outcomes can be devastating. Up to 25% of infants who experience an intracranial hemorrhage die, while 60% of those who survive have some degree of neurodevelopmental impairment, according to Nguyen. Oral vitamin K, which requires multiple doses, is not an appropriate substitute for the recommended single injection of the intramuscular formulation. The one study that compared intramuscular and oral vitamin K did not prove equivalence, and no oral vitamin K products have been approved by the Food and Drug Administration, Nguyen reported. "We do know confidently that oral vitamin K does often result in poor adherence," she said.

Small NY Study: Mother-Baby Transmission of COVID-19 Not Seen

07/30/2020

All infants born to a cohort of 31 COVID-19–positive mothers tested negative for the virus during the height of the New York surge, according to a study out of New York-Presbyterian Hospital. "It is suggested in the cumulative data that the virus does not confer additional risk to the fetus during labor or during the early postnatal period in both preterm and term infants," concluded Jeffrey Perlman, MB ChB, and colleagues. But other experts suggest substantial gaps remain in our understanding of maternal transmission of SARS-CoV-2. "Much more needs to be known," Munish Gupta, MD, and colleagues from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, said. The prospective study is the first to describe a cohort of U.S. COVID-19–related deliveries, with the prior neonatal impact of COVID-19 "almost exclusively" reported from China, noted the authors. They included a cohort of 326 women who were tested for SARS-CoV-2 on admission to labor and delivery at New York-Presbyterian Hospital between March 22 and April 15th, 2020. Of the 31 (10%) mothers who tested positive, 15 (48%) were asymptomatic and 16 (52%) were symptomatic. Two babies were born prematurely (one by Cesarean) and were isolated in negative pressure rooms with continuous positive airway pressure. Both were moved out of isolation after two negative test results and "have exhibited an unremarkable clinical course," the authors reported. The other 29 term babies were cared for in their mothers' rooms, with breastfeeding allowed, if desired. These babies and their mothers were discharged from the hospital between 24 and 48 hours after delivery.

Stillbirth Incidence Increases During COVID-19 Pandemic

07/30/2020

The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital. "The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden," Asma Khalil, MD, of St George's University of London and coauthors reported in JAMA. To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George's University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births. Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01). None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks' gestation, births after 34 weeks' gestation, neonatal unit admission, or cesarean delivery.

Cerclage in Twin Pregnancies Reduces Perinatal Mortality

07/30/2020

Among women with twin pregnancies and asymptomatic cervical dilation before 24 weeks, cerclage reduced perinatal mortality and preterm birth, according to a randomized controlled trial. The trial, which was published in the American Journal of Obstetrics and Gynecology, included 30 patients at 8 centers. The investigators stopped the trial early because perinatal mortality occurred more often in the group that did not receive the intervention. The research suggests that a combination of physical exam–indicated cerclage, indomethacin, and antibiotics decreased the incidence of spontaneous preterm birth and prolonged the period from diagnosis to delivery by an average of 5.6 weeks, compared with no cerclage. "We've already incorporated this cerclage into our practice and have been able to offer this to pregnant mothers with twins with great success," senior author Vincenzo Berghella, MD, said in a news release. "These results have the potential to change practice and help many more women have healthy twin babies," said Berghella, director of the division of maternal fetal medicine at Thomas Jefferson University in Philadelphia. More research is needed to establish a standardized approach, but the trial should "open physicians' perspectives to think about how, in selected cases and with the proper approach, cerclage can work well," said Ozhan M. Turan, MD, PhD, director of the division of maternal and fetal medicine and director of fetal therapy and complex obstetric surgery at University of Maryland in Baltimore. Although many physicians use cerclage for twin pregnancies in select situations, the practice is not well established. "If you look at the guidelines or books, mostly everyone thinks that doing a cerclage in twins is not a good idea," Turan said in an interview. In the present trial, the researchers controlled for many factors and carefully selected patients with no signs of preterm labor or infection. It is not simply a matter of saying, "Do the stitch," he said. "But it is proven: if you select patients well and use the appropriate approach, then you could improve the outcome." The study is the first randomized controlled trial of physical exam–indicated cerclage focused on twins, according to its authors. It enrolled patients between July 2015 and July 2019. In the end, the researchers analyzed data from 30 pregnancies, rather than the originally intended 52. They stopped the trial after a data and safety monitoring board considered it "unethical to continue the study due to the considerable perinatal mortality in one of the arms ... and requested to unmask the arms of the study," the researchers said. Perinatal mortality occurred in 18% of neonates in the cerclage group (6 of 34), compared with 77% in the group without cerclage (20 of 26). All perinatal mortality cases were associated with delivery before 24 weeks.

OB-GYNs Struggle to Keep Pace With Changing COVID Knowledge

07/30/2020

In early April, Maura Quinlan, MD, was working nights on the Labor and Delivery unit at Northwestern Medicine Prentice Women's Hospital in Chicago. At the time, hospital policy was to test only patients with known COVID-19 symptoms for the SARS-CoV-2 virus. Women in labor wore N95 masks, but only while pushing — and practitioners didn't always don proper protection in time. Babies came and families rejoiced. But Quinlan looks back on those weeks with a degree of horror. "We were laboring a bunch of patients that probably had COVID," she says, and they were doing so without proper protection. She's probably right. According to one study in the New England Journal of Medicine, 13.7% of 211 women who came into the labor and delivery unit at one New York City hospital between March 22 and April 2 were asymptomatic but infected, potentially putting staff and doctors at risk. Quinlan already knew she and her fellow Ob/Gyns had been walking a thin line and, upon seeing that research, her heart sank. In the middle of a pandemic, they had been racing to keep up with the reality of delivering babies. But despite their efforts to protect both practitioners and patients, some aspects slipped through the cracks. Today, every laboring patient admitted to Northwestern is now tested for the novel coronavirus. Across the country, hospital labor and delivery wards have been working to find a careful and informed balance among multiple competing interests: the safety of their healthcare workers, the health of tiny and vulnerable new humans, and the stability of a birthing mother. Each hospital has been making the best decisions it can based on available data. The result is a patchwork of policies, but all of them center around rapid testing and appropriate protection.

Living Near Gas Flaring Sites May Increase Risks

07/30/2020

Women living near oil and gas production sites where natural gas is flared may be at a higher risk of giving birth preterm, a team of California researchers reported on Wednesday. Analysis of more than 23,000 birth records from 2012 through 2015 reveals a 50% higher chance of pre-term birth for women living within three miles (5 km) of Texas' Eagle Ford shale basin than for women who lived farther away, according to the study. "Our study finds that living near flaring is harmful to pregnant women and babies," said co-author Jill Johnston, an environmental health scientist at the University of Southern California. The research, published in the journal Environmental Health Perspectives, adds to evidence linking pollution with poorer pregnancy outcomes. Another study in June found a correlation between air pollution or higher outdoor temperatures and increased chances of having a preterm or stillborn baby. Those findings, in the Journal of the American Medical Association, resulted from analyzing 70 studies covering 32 million births. It also found that black women were disproportionately at risk. In the new study, by scientists at USC and UCLA, the association between preterm births and flaring proximity was seen only among Hispanic and Latina women, who made up 55% of the study population. No effect was seen among non-Hispanic White women, who comprised 37% of the total. Preterm babies are at higher risk of respiratory and cardiovascular illness, as well as developmental delays. The team said it was the first to look at birth outcomes in relation to oil and flaring, which has seen a sharp increase in southern Texas' Eagle Ford and other shale hubs. Flares can release chemicals such as benzene, carbon monoxide and nitrogen oxides, along with fine particulate matter, heavy metals and black carbon.

Too Many Children Receive Opioids/Steroids for Pneumonia and Sinusitis

07/30/2020

A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina. Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics. "Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription," wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. "These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines." To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included. The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis. Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001). Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001). In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis. "I was disappointed to read of these results, although not necessarily surprised," Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said. The data suggest that improved prescribing practices may be needed, "especially in the ED," wrote Dr. Phang and colleagues. "Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients." Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. "Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control," they wrote.

Neotech Earns B Corp Certification

07/29/2020

Neotech announced its newly earned B Corp certification, furthering a commitment to using business as a force for good. “Since its inception, Neotech has always strived to create a lasting impact and do the right thing. Becoming certified as a B Corp is a natural step for Neotech,” said Henry Heyman, Neotech Consultant. “It’s a way to solidify many of the amazing initiatives and choices Neotech has already made.” Certifying as a B Corporation goes beyond product or service level certification. B Corp Certification is the only certification that measures a company’s entire social and environmental performance. The B Impact Assessment evaluates how a company’s operations and business model impacts its workers, community, environment, and customers. From supply chain and input materials to charitable giving and employee benefits, B Corp Certification assures that Neotech is meeting the highest verified standards of social and environmental performance. “We are extremely happy that Neotech Products has joined our community of Certified B Corporations,” said Lindsey Wilson, B Lab Senior Associate, Business Development. “Neotech’s existing culture and values align perfectly with the global B Corp movement to redefine success in business to balance both profit and purpose. With their dedication to their customers, their employees, and the community, Neotech serves as an excellent example of People Using Business as a Force for Good,” Wilson continued. In conjunction with the B Corp initiative, Neotech has recently launched the Being the Difference charitable giving program. Being the Difference launched in May 2020 with three newly-formalized opportunities to individuals and organizations in need: Product Donations, Monetary Donations and Scholarship Aid. Additionally, Being the Difference encompasses our two existing Research Grant programs.

Premature Infants Go Home Earlier

07/29/2020

A retrospective study indicates that premature infants’ stays in neonatal intensive care units (NICUs) are reduced anywhere from 4.5 to 22.9 days when fed Prolacta Bioscience 100% human milk-based products as a part of an Exclusive Human Milk Diet (EHMD). Additional research suggests that infants with bronchopulmonary dysplasia (BPD), a common complication of prematurity, may benefit the most from an EHMD when it comes to shortening their hospital stays. A retrospective study published in the Journal of Perinatology found that 293 infants between gestational ages 23 and 34 weeks and birth weights between 490 and 1,700 g who received Prolacta’s fortifiers as part of an EHMD achieved full feeds at faster rates and ultimately reduced their NICU stay by 4.5 to 22.9 days, compared with infants fed their mother’s milk with a cow milk-based fortifier or a combination of mom’s milk with cow milk-based fortifier and formula. Frontiers in Pediatrics published findings from a study of more than 12,000 premature infants born at ≤ 28 weeks indicating that among the 41% who developed BPD, hospital stays were 19 days longer on average (P = .001) than those who did not develop BPD. A secondary analysis of a study that originally looked at the impact of Prolacta’s cream fortifier on growth among premature infants weighing 750 to 1,250 g showed that adding Prolacta’s human milk-based cream fortifier to an EHMD resulted in an average stay in the NICU that was 12 days shorter, from 86 days without the cream supplement to 74 days when it was used. In this study, the infants with BPD may have benefited the most from the addition of Prolacta’s cream fortifier, with 17 fewer days in the NICU, from an average of 121 to 104 days (P = .08). This updated analysis was published in Breastfeeding Medicine in 2016. A 2019 study published in Advances in Neonatal Care compared 104 infants born weighing ≤ 1,250 g who received an EHMD to a similar group of 101 infants who received cow milk-based fortifier. In this study, an EHMD was associated with decreased rates of BPD (P = .018) and sepsis (P = .06) and an average five-day reduction in length of hospital stay. “The goal of all parents with a premature infant in the NICU is to bring their baby home as soon as possible. When you add the concerns about exposure to hospital-based infections for both the parents and the baby, that desire for discharge is stronger than ever,” said Melinda Elliott, M.D., chief medical officer of Prolacta. “The clinical evidence shows an EHMD including Prolacta’s products helps to overcome the complications of prematurity, resulting in better health outcomes and shorter hospital stays in the NICU.”

Study Results Released on Screening for Newborns

07/20/2020

Masimo announced the results of a prospective study published in the International Journal of Neonatal Screening in which researchers in Marrakesh, Morocco, conducted the first Moroccan study on critical congenital heart disease (CCHD) screening for newborns using Masimo SET pulse oximetry. The authors concluded that “Our results encourage us to strengthen screening for CCHD by adding pulse oximetry to the routine newborn screening panel.” Slitine and colleagues sought to improve early detection of CCHD in Morocco by studying the feasibility of implementing CCHD screening using pulse oximetry. From March 2019 to January 2020, 8,013 asymptomatic newborns at Mother and Child Hospital (part of the Mohammed VI University Hospital of Marrakesh), who were “normal” according to neonatal examination using the current standard, were screened for CCHD in accordance with American Academy of Pediatrics (AAP) guidelines, including pre- and post-ductal oxygen saturation measurement, using Masimo Rad-97 and Radical-7 Pulse CO-Oximeters with Masimo SET pulse oximetry sensors. The researchers found that, of the 8,013 infants screened, 7,998 newborns had a negative screen (99.82%) and 15 newborns were screen positive (0.18%). Of those 15, five were later diagnosed with CCHD and five with non-critical CHD; five were false positives (three of which had other underlying conditions). Of the 7,998 infants who passed, there was one false negative, an infant who was later diagnosed, at 2 months of age, with coarctation of the aorta. The researchers noted that the screening test was “easy, simple, reliable, reproducible, acceptable, discriminating, well-accepted by parents and caregivers, and did not involve parental anxiety.” They also noted that “Pulse oximetry has a good specificity and sensitivity and thereby fulfills the criteria for screening. Additionally, most of the data in the literature suggest a favorable cost-effectiveness of this technique.” The authors concluded, “Screening for CCHD is a reliable method for the early detection of critical congenital heart disease and even non-cardiac conditions. We think that it will have positive repercussions on infant mortality and morbidity in Morocco. It is an optimal test and it adapts perfectly to our context. We hope to implement it locally and nationally, as consistent with international best practice for newborn screening, to allow for timely detection of the infants born with CCHD in Morocco.”Although the researchers at times use the term pulse oximetry generally, the specific pulse oximetry technology used in this study, as noted, was Masimo SET. To date, six other large published CCHD screening studies, as well as additional, smaller studies, have used Masimo SET. Cumulatively, the large studies represent 284,800 infants, which includes the largest CCHD study to date, of 122,738 newborns. All of these CCHD studies with Masimo SET pulse oximetry showed improved screening sensitivity with the use of Masimo SET alongside clinical assessment when compared to routine physical exam alone. With its ability to accurately measure through motion and low perfusion, alongside its performance in outcome studies, Masimo SET stands out as the established choice of pulse oximetry technology for clinicians and policy makers hoping to implement CCHD screening processes.

Sign Up for This Webinar on Gut Health

07/15/2020

Astarte Medical has an upcoming webinar with Dr Nicholas Embleton.
Registration and Complete Event Details: https://bit.ly/2C6EN4e
Event: Nutritional Status and Gut Health in Preterm Infants What is it, and how do we assess it?
Featured Speakers: Dr. Nicholas Embleton
Date: Wednesday, July 29, 2020
Time: 12:00 p.m. ET
Topics of discussion will include:

• A comprehensive practical approach to nutrition requires recognition of multiple interacting elements.
• Nutrition includes 1) nutrients 2) functional components 3) microbiome 4) socio, techno, behavioral aspects.
• Breastmilk is more than food.
• Nutritional status is a multidimensional and dynamic concept - what you are, what you eat, what you can do.
• Assessment of nutritional status requires a structured approac
• Gut health is a continuum rather than a binary outcome of 'healthy' or 'unhealthy.'

CDC Revises COVID-19 Risks During Pregnancy as Research Lags

07/15/2020

In late June, after three months of near silence on the topic, the Centers for Disease Control and Prevention finally weighed in on a question of critical importance to millions of American women and families: How dangerous is the coronavirus for pregnant women and new mothers? The CDC had been asserting that pregnant women don't seem to be at higher risk for severe complications from the virus. As recently as late May, a spokesperson told ProPublica, "Current evidence shows pregnant women have the same risk of severe illness from Covid-19 as adults who are not pregnant." Then, the agency abruptly changed its tone. In its first examination of data on Covid-19 in pregnancy, the CDC found that expectant mothers with the virus had a 50 percent higher chance of being admitted to intensive care and a 70 percent higher chance of being intubated than nonpregnant women in their childbearing years. Pregnant Latina and Black women were infected at significantly higher rates than White women, researchers reported. As of July 2, at least 30 expectant and new mothers with the virus had died. That news was sobering enough. But what many experts found really worrisome were the glaring gaps in data that the study exposed. The CDC acknowledged that crucial health information was missing for about three-quarters of pregnant women with the virus, including whether they had preexisting conditions or required an ICU stay or mechanical ventilation. For the vast majority of US women of reproductive age who tested positive — about 326,000 women through June 7 — there was no information about pregnancy status at all. Researchers couldn't even say how many of the hospitalized mothers-to-be — 31.5 percent of the pregnant women in the study — had been admitted because of Covid-19, versus how many were in the hospital for other reasons, such as giving birth. The flawed CDC report highlights a problem that OB-GYN providers and researchers in the U.S. have been fretting about since the pandemic began. Because emerging diseases can have catastrophic consequences for pregnant women and their babies, close monitoring of new illnesses in this vulnerable population is important. So is rapid communication with providers trying to keep their patients safe. But the US public health system's efforts to understand the impact of the coronavirus in mothers and babies have been flat-footed, scattershot and agonizingly slow.

'Time to Lay to Rest' Fears About Dolutegravir Birth Defects

07/15/2020

The longer researchers have looked for evidence of neural tube defects linked with dolutegravir treatment of HIV at the time of conception the fewer incident cases they've found. The newest data, based on 3,591 deliveries among women in Botswana infected by HIV and treated with dolutegravir at the time of conception during a little more than 5.5 years through April 2020, showed that dolutegravir use at conception linked with 7 cases of neonatal neural tube defects (NTDs), a 0.19% rate that exceeded comparator rates by about 1 in every 1,000 deliveries, far below the 0.94% rate initially found and that raised a red flag 2 years ago. "The prevalence of NTDs among infants born to women on dolutegravir at conception may be stabilizing at approximately 2 per 1,000," said Rebecca Zash, MD, during the virtual meeting of the International AIDS conference. "This small absolute risk for neural tube defects is far outweighed by the potential benefits from dolutegravir" for better tolerability than alternative drugs and fewer drug–drug interactions. "This should allow for broader use of dolutegravir in women," added Zash, an HIV specialist at Beth Israel Deaconess Medical Center and codirector of the Placental Scientific Working Group of the Harvard University Center for AIDS Research, both in Boston. "What this has taught us is that women are not a niche population" of people infected with HIV, but rather constitute about half of HIV patients worldwide. "Maintaining gender equity in HIV treatment requires safety data for treatments during pregnancy," she said during a press briefing. The new findings mean that it's "time to lay to rest" concerns about neural tube defects in infants born to women treated with dolutegravir, "given the incredible benefits of dolutegravir," commented Monica Gandhi, MD, professor of medicine and associate chief of the division of HIV, infectious disease, and global medicine at the University of California, San Francisco. Another benefit from removing any caveats about use of dolutegravir in women who could become pregnant is that it would simplify treatment recommendations and make dolutegravir the unqualified first-line agent for treating HIV infection, Dr. Gandhi said during the briefing. "It's super reassuring to have these data, as the incidence of NTDs goes down and down," she added. Following the alarm raised by initial findings from the Tsepamo study in 2018, Zash and associates first updated their data through March 2019, when they reported a revised cumulative NTD incidence rate of 0.3%. The Tsepamo study began by following the pregnancy outcomes of women at eight Botswana sites during August 2014–July 2018, representing 45% of the country's deliveries. This expanded to 18 sites and 72% of deliveries during July-–September 2018, and then starting in September 2019 the scope slightly reduced to 16 Botswana sites with 70% of the nation's deliveries. Folate supplementation to women who might conceive is vital, but remains spotty in Botswana. "Folate supplementation is a no-brainer, but has had really slow adoption in many countries," Zash said. "Folate supplementation, especially in food so that everyone gets it, will reduce NTDs by half." The two most recent cases of infants born with a NTD to mothers who had been on dolutegravir at conception occurred in mothers who had received no folate supplementation, Zash reported.

Neonatal SARS-CoV-2 May Present With Hypoxemia Without Respiratory Distress

07/15/2020

Neonatal SARS-CoV-2 infection may present in the first days of life with clinically significant hypoxemia in a newborn that doesn't have overt signs of respiratory distress or require oxygen therapy, one case report suggests. "In mild disease, there may be non-specific signs such as poor feeding that alert the care-providers, before signs of respiratory distress are noted," said Dr Shaili Amatya, an assistant professor in neonatal-perinatal medicine at Penn State Health Children's Hospital in Hershey, Pennsylvania, who wasn't involved in the study. "The physiological mechanisms underlying the effects in infants versus older children are unknown," Amatya said by email. "The immature immune system of children may respond to SARS-CoV-2 differentially in various age groups." The case, highlighted in Pediatrics, involved a full-term male newborn with an uncomplicated vaginal delivery with Apgar scores of 9 and 10 at 1 minute and 5 minutes, respectively. On the second day after delivery, the mother developed a fever and had a nasopharyngeal swab that was positive for SARS-CoV-2; the infant was subsequently swabbed, and also positive. Mother and baby were transferred to an airborne isolation room. After 48 hours, the newborn developed poor sucking and perioral cyanosis without signs of respiratory distress. The baby's respiratory rate was 15 to 20 per minute, heart rate was 120 beats per minute, and blood pressure was normal. Cardiac abnormalities were ruled out by echocardiogram, and PCR on the nasopharyngeal specimen ruled out other respiratory viruses. The baby was moved to the NICU, where he was put on 30% inspired oxygen via high flow nasal cannula. Lung ultrasound at this point didn't show consistent abnormalities, and chest radiograph showed mild bilateral ground glass opacities. After 36 hours, no major abnormalities were found on CT scan. Fifty hours after NICU admission, the infant improved enough to have respiratory support discontinued. He was fed maternal expressed milk via nasogastric tube for 48 hours, then was able to bottle feed. At day 18, the baby was discharged. On days 15 and 21, his qualitative PCR for SARS-CoV-2 remained positive, the researchers note. This suggests that newborns could be a source of horizontal transmission, the study team concludes in Pediatrics.

 

Fortifiers Helped Infants Grow

07/14/2020

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, announced the results of an independent, multicenter study of 394 extremely premature infants that demonstrated the benefits of an early versus late fortification feeding protocol. According to this study, the use of Prolacta’s fortifiers in the first days of life helped premature infants achieve better growth and is associated with significantly less bronchopulmonary dysplasia (BPD)/chronic lung disease of prematurity (CLD), all without compromising safety. The study was led by author Robert K. Huston, MD, and published in the Journal of Neonatal-Perinatal Medicine. Lung health is an important short- and long-term outcome for preterm infants. However, because the lungs are among the last organs to mature in the womb, lung dysfunction such as BPD/CLD is common in preterm infants. Neonatal nutrition is a critical consideration in addressing lung health; however, many neonatal intensive care units (NICUs) delay adding a fortifier to extremely premature infants’ feeds due to the risk of complications associated with cow milk-based fortifiers. This study showed that adding Prolacta’s human milk-based fortifiers in the first days of life resulted in greater growth velocities for weight and head circumference and a 15% reduction in BPD/CLD (P = 0.008), compared with infants who received late fortification. These benefits were seen without an increase in complications. Infants who received early fortification in the study did not show significant increases in necrotizing enterocolitis (NEC) or surgical NEC, life-threatening complications that limit the use of early fortification with cow milk-based fortifiers. The Huston Early Fortification Study investigators compared the outcomes of infants born weighing 500 to 1,250 g whose feedings included mother’s own milk, donor milk when needed, and Prolacta’s human milk-based fortifiers at less than 60 mL/kg/day (early fortification) or greater than 60 mL/kg/day (late fortification). “The Huston Early Fortification Study provides further data to support the practice of early fortification in extremely premature infants,” said Melinda Elliott, M.D., chief medical officer of Prolacta Bioscience. “Not only was early fortification proven safe, it also enhanced growth and reduced the incidence of BPD.”

Babies Born With Virus, Parents Don’t Have It

06/30/2020

Mexican health authorities are trying to understand how a set of newborn triplets became infected with the novel coronavirus even though neither one of their parents tested positive for the virus. Health authorities called the case "unheard of." The triplets, a girl and two boys, were tested four hours after being born about six weeks early last week in the central state San Luis Potosi, health authorities said. State Health Secretary Dr. Monica Liliana Rangel Martinez told reporters that it is protocol to test all premature babies for the virus. Initially, health authorities said the mother was believed to be an asymptomatic carrier of the virus. But her tests later showed that neither she nor the father were infected. "The parents' results are negative, which catches our attention," Martinez said. "We specifically requested since yesterday ... that a group of experts investigates the case." Two of the babies born on June 17 are in good health and show no symptoms of COVID-19, doctors treating the triplets said, while the third has pneumonia but is in stable condition. Rangel said the triplets will remain hospitalized and under observation. Mexico has reported more than 191,000 coronavirus cases and 23,377 deaths, according to the global tracking dashboard being kept by Johns Hopkins University.

Women, Babies at Risk as COVID-19 Disrupts Health Services

06/30/2020

Millions of women and children in poor countries are at risk because the COVID-19 pandemic is disrupting health services they rely on, from neonatal and maternity care to immunisations and contraception, a World Bank global health expert has warned. Monique Vledder, head of secretariat at the bank's Global Financing Facility (GFF), told Reuters in an interview the agency was gravely worried about the numbers of children missing vaccinations, women giving birth without medical help and interrupted supplies of life-saving medicines like antibiotics. "We're very concerned about what's happening - particularly in sub-Saharan Africa," Vledder said as she unveiled the results of a GFF survey, one of the first seeking to assess the impact of COVID-19 on women's and children's health. "Many of the countries we work in are fragile and so, by definition, already have very challenging situations when it comes to health service delivery. This is making things worse." From late March, the GFF has conducted monthly surveys with local staff in 36 countries to monitor the impact of COVID-19 on essential health services for women, children and adolescents. Sharing the survey findings, GFF said that of countries reporting, 87% said the pandemic, fears about infection or lockdown measures designed to curb the spread of the coronavirus, had led to disruptions to health workforces. More than three-quarters of countries also reported disruptions in supplies of key medicines for mothers and babies, such as antibiotics to treat infections and oxytocin, a drug for preventing excessive bleeding after childbirth. The number of GFF countries reporting service disruptions nearly doubled from 10 in April to 19 in June, and the number reporting fewer people seeking essential health services jumped to 22 in June from five in April. GFF found that in Liberia, for example, fears about COVID-19 were preventing parents from taking their children to health clinics. In Ghana, some pregnant and lactating mothers were opting to postpone antenatal services and routine immunisations for fear of contracting the pandemic disease.

New Data on Hypertension

06/30/2020

Using the new clinical definitions of hypertension, pregnant women with even modest elevations in blood pressure (BP) are at increased risk for preeclampsia, according to results from a large retrospective cohort study. In a 2017 guideline, the American College of Cardiology and American Heart Association changed clinical definitions of hypertension in adults. People previously deemed to have prehypertension were classed as having elevated blood pressure (systolic BP 120-129 mm Hg and diastolic BP >80 mm Hg) or stage 1 hypertension (systolic 130-139 mm Hg or diastolic 80-89 mm Hg). And while hypertension as earlier defined (at or above systolic 140 mm Hg or at or above diastolic 90 mm Hg; now called stage 2 hypertension) has been long associated with adverse maternal and fetal effects, it was unclear whether lesser elevations in blood pressure also are linked to the same. For their research published in Obstetrics & Gynecology, Elizabeth F. Sutton, PhD, of the University of Pittsburgh and colleagues looked at records from 18,162 women who had given birth to a single baby and had two or more prenatal appointments before week 20 of pregnancy. The women in the study were seen at the same institution over a 3-year period ending in 2018. Three-quarters of the cohort had normal blood pressure, while 14% had elevated blood pressure and 5% had stage 1 hypertension before 20 weeks. Another 6% of the cohort had stage 2 hypertension. The authors found preeclampsia risk increased with increasing blood pressure elevation. Among women with normal blood pressure before 20 weeks' gestation, 5% had preeclampsia, while 7% of those with elevated blood pressure did, as did with 12% of women with stage 1 hypertension and 30% of women with stage 2 hypertension. The increase in risk of preeclampsia was because of preterm preeclampsia in the women with elevated blood pressure. Both term and preterm preeclampsia were factors in women with stage 1 and stage 2 hypertension, but preterm preeclampsia was associated with a higher risk. Although black race was associated with a higher risk of preeclampsia, the pattern of increasing risk with higher blood pressure category was similar in both black and white women. Researchers also looked at gestational diabetes, severe maternal morbidity, neonatal morbidity, and placental abruption as secondary outcomes. They found the risk of gestational diabetes increased in a stepwise fashion as blood pressure increased, compared with normotensive women. Higher risk of severe maternal and neonatal morbidities was seen only in women with stage 2 hypertension. Placental abruption was rare in this cohort and the odds were not increased in any group. The findings "highlight the importance of early pregnancy BP elevations, which may reflect prepregnancy BP status," and suggest that the new guidelines "can identify women early in pregnancy who may benefit from increased surveillance," Dr. Sutton and colleagues wrote.

Cesarean Delivery Tied to Worse Outcomes in Women With COVID-19

06/30/2020

Cesarean delivery was associated with severe maternal outcomes and clinical deterioration compared to vaginal delivery among women infected with COVID-19 in Spain. "We were really surprised by the high rate of cesarean section in (COVID-19 patients) in China," Dr David Baud of Lausanne University Hospital in Switzerland, said. "We were not so surprised to discover (in our own study) that vaginal delivery is safer in (such) patients." Baud and colleagues studied data on women in Spain with SARS-CoV-2 and singleton pregnancies between March 12 and April 6, 2020, and who delivered within the next 14 days. As reported in JAMA, among the 82 participants, four presented with severe COVID-19 symptoms, including one with concomitant preeclampsia. All four underwent cesarean delivery and required ICU admission. Seventy-eight women presented with no or mild COVID-19, including 11 who required oxygen supplementation. Forty-one (53%) delivered vaginally and 37 (47%) by cesarean delivery for obstetrical indications and eight for COVID-19 symptoms without other obstetrical indications. Compared to those delivering vaginally, women who underwent cesarean deliveries were more likely to be multiparous, obese, require oxygen at admission, and have abnormal chest x-ray findings. No severe adverse outcomes occurred in women who had a vaginal delivery. However, five (13.5%) who underwent a cesarean required ICU admission. Two (4.9%) with a vaginal delivery experienced clinical deterioration after birth vs eight (21.6%) with cesarean delivery. After adjustment for potential confounders, cesarean birth was significantly associated with clinical deterioration (adjusted odds ratio, 13.4). Eight newborns (19.5%) delivered vaginally and 11 (29.7%) born by cesarean delivery were admitted to the neonatal ICU. After adjustment, cesarean birth was significantly associated with an increased risk of NICU admission (aOR, 6.9). Three newborns delivered vaginally tested within 6 hours after birth had a positive SARS-CoV-2 RT-PCR result. However, repeat testing at 48 hours was negative. None developed COVID-19 symptoms within 10 days.

The evidence for HeRO continues to build

06/29/2020

Two more publications about HeRO are now available. Please check the company’s publications page on its website regularly for the details and links to all the papers. If you have ideas for new research topics or if you are interested in deploying HeRO in your unit, then reach out. Following their earlier work on the use of HeRO with respect to intubation and extubation, Chakraborty et. al, have published Predicting Extubation Outcomes Using Heart Rate Characteristics Index in Preterm Infants: A Cohort Study. They present predictive models that assess readiness for extubation using physiological data and HeRO. These models are freely available, hosted by MPSC.

Device Helps Neonatal Oral Intubations

06/16/2020

The SecureET Neonatal Endotracheal Tube Securement Device from Westmed (westmedinc.com) is the latest design available for neonatal oral intubations. The SecureET Endotracheal Tube holder features hydrocolloid material for skin contact and helps prevent accidental extubation by providing a secure method of stabilization. SecureET enables fast and easy application to secure endotracheal tubes sizes 2.5, 3.0, 3.5, and 4.0 mm. Each device is color coded for the size tube. SecureET facilitates placement options for the tube location in the oral cavity and may be moved to prevent palate grooving. SecureET allows for tube depth adjustment without disturbing the skin contacting hydrocolloid base. In addition, SecureET is the only neonatal ET Tube securement device with an optional head bonnet for superior security.

Doctors Can Help Parents Cope in the NICU

06/15/2020

Parenting a newborn can be a tough journey, and bonding with a new baby in a neonatal intensive-care unit (NICU) is even more difficult given the medical uncertainties, fear and complex emotions, according to a group of pediatricians. But healthcare providers can help parents cope, the group writes in Pediatrics, by communicating three messages: You are a parent, you are not a bad parent, you are a good parent. "When your child is sick, it is not rare for parents to wonder what they could have done to prevent the illness," said Dr Annie Janvier of Sainte-Justine University Medical Centre in Montreal, Canada, one of the authors of the report. In a NICU, the feelings are even more intense, she added. Mothers may feel their baby is sick because of their body, and fathers may feel helpless about what to do.

"Finding your parental roles in the NICU and feeling like a parent can take some time," she told Reuters Health by email. "Sometimes you can also feel ambivalence attaching because you are scared your baby will die." Janvier and colleagues at several hospitals in the US and Canada write about the stress that parents face in the NICU, as well as several strategies that doctors can take to help parents. They write from their experience as healthcare providers and also as parents or grandparents who have had children in the NICU. "Clinicians can harm parents inadvertently, for example, when they assume that 'mothers love to take their kid in their arms,' as some mothers may be frightened at first when their baby is unstable," Janvier said. Doctors and NICU providers can help parents by supporting "good parent" beliefs, which can guide parenting and decision-making and reduce anxiety, depression, prolonged grief and posttraumatic stress disorder, they write. The first message to communicate is "You are a parent," the authors write, because parents of infants in the NICU need to feel like "real" parents. They may feel conflicted about whether to invest emotionally in a baby who could die, looks fragile or could have future health problems.

When doctors use medical language such as "nonviable" or "congenital anomalies incompatible with life," these feelings are exacerbated, the authors write. Separation after birth, and breathing tubes and wires can interfere with bonding.

Possible Vertical Transmission of Novel Coronavirus

06/15/2020

Clinicians in Italy report two cases of possible vertical transmission of SARS-CoV-2, the virus responsible for COVID-19, from the mother to the baby in utero. "To our knowledge, ours is the first report of cases of positive polymerase chain reaction (PCR) for SARS-CoV-2 in mother, neonate and placental tissues," Dr Luisa Patane and colleagues of ASST Papa Giovanni XXIII in Bergamo write in the American Journal of Obstetrics and Gynecology - Maternal Fetal Medicine. Vertical transmission of SARS-CoV-2 remains controversial and studies on placental correlations are limited. Patane and colleagues report that between March 5 and April 21, two of 22 babies born to women with COVID-19 were PCR positive for SARS-CoV-2 in nasopharyngeal (NP) swab samples. The first baby, a boy, was born vaginally after spontaneous labor at around 37 weeks' gestation to a mother who was experiencing fever and cough and had a positive SARS-CoV-2 NP swab. The mother wore a surgical mask during labor and delivery, skin to skin contact was not allowed, but rooming-in and breastfeeding with mask were allowed. The baby had positive NP swabs immediately at birth, after 24 hours, and after seven days. He remained asymptomatic, except for mild initial feeding difficulties, and was discharged from the hospital at 10 days of life. The second baby, a girl, was delivered by cesarean section at 35 weeks' gestation to a mother who had also had fever and cough and positive COVID-19 NP swab. The baby was immediately separated from the mother at birth and admitted to the neonatal intensive-care unit. The baby had a negative NP swab at birth and a positive NP swab at day seven, with no contact between mother and neonate during that period. No neonatal complications were observed, only some feeding difficulties were reported in the first days of life; she was discharged at 20 days life 20. In both cases, SARS-CoV-2 RNA was found in placental tissue. The presence of SARS-CoV-2 RNA in the syncytiothrophoblast - the epithelial covering of the embryonic placental villi, which invades the wall of the uterus to establish nutrient circulation between the embryo and the mother - signifies presence of the virus on the fetal side, the clinicians point out. "This is the first study describing SARS-CoV-2 RNA on the fetal side of the placenta in two cases of mothers infected with COVID-19 and with neonates also positive for the virus at birth," they note.

Breastmilk of Mother With COVID-19 Tests Positive for SARS-CoV-2

06/15/2020

Breastmilk samples from a nursing mother infected with SARS-CoV-2 has tested positive for the virus, researchers report. "The breastmilk of SARS-CoV-2-infected women may contain the virus. However, we described a single case and currently do not know how frequent this is, whether the virus in milk is infectious and whether it may indeed be transmitted to the newborn by breastfeeding," Dr Jan Muench of the Institute of Molecular Virology at Ulm University Medical Center in Germany said by email. Small studies have not found evidence of SARS-CoV-2 shedding into breastmilk, Muench and colleagues write. They tested milk from two nursing mothers with SARS-CoV-2 using RT-qPCR. Mother 1 developed symptoms of COVID-19 after delivery and tested positive for SARS-CoV-2. The newborn tested positive for SARS-CoV-2 and had respiratory symptoms. Both mother and infant recovered. Four breastmilk samples were taken from Mother 1 and all were negative for the virus. Mother 2 and Newborn 2 were put in the same room as Mother 1 and Newborn 1. They were discharged on day 4. Mother 2 developed mild COVID-19 symptoms, and both she and her baby tested positive for SARS-CoV-2. The baby was readmitted to the hospital due to icterus and breathing problems. On days 10 to 13 after initial hospital admission, breastmilk samples from Mother 2 tested positive for the virus. Two subsequent samples were negative. The authors note that Mother 2 had been wearing a surgical mask after she developed COVID-19 symptoms and followed safety precautions while feeding and handling the baby. "We plan to recruit more infected mothers to 1) determine how often SARS-CoV-2 is present in milk and at which quantities; 2) to figure out whether the virus in milk is indeed infectious; 3) to check whether the virus in milk could be inactivated by pasteurization and/or storage 4) to check for anti-SARS-antibodies in milk and their neutralization efficiency; and 5) finally proof whether the virus may be transmitted via breast milk to the newborn," Muench said.

Placental Injury Reported in Women With COVID-19

06/15/2020

Maternal vascular malperfusion and intervillous thrombi were more common in the placentas of women infected with SARS-CoV-2, compared with historic controls, report researchers who conducted the first-of-its-kind case series in the English literature. Nevertheless, the neonates in the report appear to be healthy so far and all tested negative for the virus. Although the series examining placentas from 16 women is small, it carries a larger implication – that increased antenatal surveillance for pregnant women infected with SARS-CoV-2 may be indicated, the researchers noted. Furthermore, the results could align with other reports of coagulation and vascular abnormalities among people with COVID-19. "I would say that our findings fit into that larger picture of vascular injury. This is developing, and there are some significant ways that these feeder vessels to the placenta are different, but if this is the emerging paradigm, our findings can fit into it," Jeffrey A. Goldstein, MD, PhD, assistant professor of pathology at Northwestern University, Chicago, said in an interview. The research was published in the American Journal of Clinical Pathology. Prior case series reported in Wuhan, China, do not currently suggest that pregnant women are more likely to experience severe COVID-19, in contrast to observations during severe acute respiratory syndrome and Middle East respiratory syndrome outbreaks. "However," the researchers noted, "adverse perinatal outcomes have been reported, including increased risks of miscarriage, preeclampsia, preterm birth, and stillbirth." To learn more, Dr Goldstein, lead author Elisheva D. Shanes, MD, and colleagues examined the histology of placentas from women with COVID-19 giving birth between March 18 and May 5, 2020. They compared these placentas with over 17,000 historic controls and 215 women who had their placentas evaluated as part of a melanoma history study.

Study Highlights Growth of Babies

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, announced the results of a long-term pilot study showing that premature infants fed an exclusive human milk diet (EHMD) including Prolacta’s fortifiers reached the same healthy growth and developmental milestones by age 2 that are seen in full-term infants. The study was published in the May 2020 issue of Breastfeeding Medicine. Authored by Erynn M. Bergner, M.D., and colleagues, the new study is the first to concurrently evaluate long-term neurodevelopmental, growth, and body composition outcomes of preterm infants in the neonatal intensive care unit (NICU). Researchers found: Preterm infants receiving Prolacta’s 100% human milk-based fortifiers returned to birth z-scores for weight, length, and head circumference by age 2; similar percentage of body fat and lean mass in preterm infants at age 2, compared to matched term controls, with adequate bone mineralization; not a single case of severe cognitive developmental delay using a Bayley Scales of Infant and Toddler Development III (BSID-III) cutoff score of <70 at 18 to 22 months corrected age (CA). “As we continue to optimize nutritional practices in the NICU and investigate an entirely human milk-based approach for the diets of preterm infants, it is important to follow the potential impact of these changes on health and development long-term,” Dr Bergner wrote. Bergner et al evaluated the post-discharge growth, body composition, and neurodevelopmental outcomes of a cohort of infants ≤1,250 g birth weight who received Prolacta’s fortifiers as part of an EHMD in the NICU. The infants were studied prospectively at two outpatient visits: 12 to 15 and 18 to 22 months (CA). Dual-energy X-ray absorptiometry and BSID-III were performed at 18 to 22 months (CA). “The Bergner study demonstrates what we’ve long suspected – that the numerous health benefits we see in the NICU with Prolacta products as part of an Exclusive Human Milk Diet translate into longer-term neurodevelopmental and metabolic health outcomes,” said Melinda Elliott, chief medical officer for Prolacta Bioscience.

Probiotics Receive Conditional Recommendation

Babies born preterm—before 37 weeks of gestation—account for approximately 15 million births worldwide each year, according to the World Health Organization. This extremely vulnerable population of infants are at risk for multiple complications, including susceptibility to NEC, a serious disease that causes tissue damage to the intestines resulting from bacteria invading the intestinal walls. The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) working group on probiotics and prebiotics conducted an extensive review of the clinical evidence surrounding probiotic use in the NICU. The working group published guidelines conditionally recommending specific strains of probiotics, including the combination of B.infantis (BB-02), B.lactis (BB-12), and S.thermophilus (TH-4), as it might reduce NEC stage 2 or 3 in preterm infants (low certainty of evidence), provided all safety conditions are met. The safety conditions include use of strains without transferable antibiotic resistance genes, correct strain identity and lack of product contamination that were manufactured in accordance with good manufacturing practices (GMPs). The authors note that only a limited number of strains have shown clinical effectiveness in this patient population. The guidelines also highlight the importance of assessing the safety in overall product manufacturing. This includes understanding a probiotic’s potency, stability and purity. Preterm infants are deprived of adequate time in utero for growth of critical organs, including the digestive system where 70% of the immune system resides. In addition to an underdeveloped digestive system, preterm infants can experience imbalances in gut bacteria. The use of probiotics in this population may reduce the incidence of NEC. Currently ~20% of NICUs in the United States use probiotics when treating and caring for preterm infants. “A high-quality probiotic that has been studied in preterm infants would equip clinicians in the NICU with the ability to mitigate some of the risks associated with preterm births, including necrotizing enterocolitis, that can affect these babies,” said Dr Karyn Wulf, MD, MPH, Pediatric Medical Director at Abbott. “The ability for medical professionals to provide best-in-class care using nutrition allows them to proactively support a strong start in life.”

For Mothers With Coronavirus, Baby's First Coo Is Over the Phone

"It's a girl and she is fine, we all are fine," said Rayhona, 23. "They have shown her to me on a smartphone." More than 150 babies have been born to mothers with suspected coronavirus infections at Moscow's City Clinical Hospital Number 15, and the hospital says not a single newborn caught the infection. But to achieve that, the babies are separated from their mothers at birth, breastfeeding is banned, and the mothers are kept quarantined in a ward for two weeks. Rayhona wore a mask and was hooked up to medical devices, sharing a room with another new mother also suspected of carrying the virus. The mothers "are admitted with some respiratory distress already and we need to be very professional to determine when to deliver the baby and how to deliver it," the hospital's head doctor, Valeriy Vechorko, said. "I can say this for sure — we did not have a single transmission of the virus to a baby." Until they are released from quarantine, mothers can communicate with their new babies only via video calls. The mothers "are scared - more scared than usual at least — as they are worried not only about themselves but about their baby as well," said hospital cardiologist Olga Lapochkina. "We try to keep mothers in touch with the babies via video links. Doctors show them and it really helps."

Companies Reinforce Partnership

Masimo and Royal Philips, both global leaders in patient monitoring, announced that they have reinforced their partnership, whereby Philips will integrate additional Masimo measurement technologies into select IntelliVue MX-series multi-parameter monitors, to help clinicians assess cerebral oximetry and ventilation status. Core Masimo noninvasive measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry and advanced rainbow SET Pulse CO-Oximetry parameters like noninvasive hemoglobin (SpHb), have long been available on a wide range of Philips multi-parameter monitors. In 2016, Masimo and Philips entered into a multi-year business partnership involving both companies' innovations in patient monitoring and therapy solutions. Now, in 2020, Philips becomes one of Masimo's first industry partners to launch additional advanced Masimo measurements, NomoLine and O3, in their own patient monitors, sharing Masimo's expertise in capnography and regional cerebral oximetry with caregivers and patients around the world. NomoLine capnography and O3 regional oximetry measurements are available now on Philips MX500 and MX550 monitors in select markets throughout the world, and are also available directly from Masimo on its Root Patient Monitoring and Connectivity Platform and when connected to select Philips patient monitors via Philips' IntelliBridge module: NomoLine "no-moisture" sampling lines are designed for low-flow applications and can be used in a variety of clinical scenarios and care settings, on both intubated and non-intubated patients of all ages, in both low- and high-humidity applications. O3 regional oximetry may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.

HCV-Exposed, Uninfected Infants Show B-Cell Changes

Many uninfected babies born to mothers with chronic hepatitis C virus (HCV) infection may have already fought off the virus themselves, new research suggests. Infants exposed to the virus but not infected had immune system changes similar to those of HCV-infected infants, including high numbers of virus-specific IgG-secreting B cells, more IgA-positive plasma cells and upregulation of CD40, compared with unexposed and uninfected infants, Dr Niklas K. Bjoerkstroem of Karolinska University Hospital in Stockholm and colleagues found. "It seems to be a specific thing that happens within the B cells within these exposed children," Bjoerkstroem said. "It gives us some insight into why it's such a rare instance that hepatitis C is vertically transmitted." The risk of mother-to-child transmission (MTCT) in pregnant women with HCV is not clear, but it is estimated at approximately 5%, lower than for chronic hepatitis B virus and HIV, Dr. Bjoerkstroem and his team note in Gut. Some uninfected children born to mothers with HCV have HCV-specific T-cell responses, they add. To investigate B-cell-mediated immunity and HCV exposure, the authors looked at 55 mothers and their babies delivered at a hospital in Saint Petersburg, Russia, from 2012 to 2016. Infants underwent peripheral blood mononuclear cell (PBMC) sampling at birth and at six, 12 and 18 months. Forty of the mothers were HCV-RNA positive when the babies were born and 15 were negative, indicating that they had cleared the virus. Their infants were classified as unexposed. Among the 40 exposed infants, three became HCV-RNA positive during the follow-up period, and were classified as infected.

Children who became infected had higher mean levels of HCV-specific Ig-G secreting B cells than the children who were exposed but uninfected and the unexposed group. Mean levels of HCV-specific Ig-G secreting B cells were similar for the exposed but uninfected and the unexposed groups, but some exposed individuals had "robust responses." IgA-positive plasma cells were identified in 28.9% of infected children, 29.7% of exposed children and 15.1% of unexposed children, with a similar pattern for IgG-positive plasma cells. Infected children also had changes in myeloid immune cells and natural killer cells and a soluble factor profile with high levels of inflammatory cytokines and chemokines, none of which were seen in the exposed group.

COVID-19 Severity in Pregnancy Appears Lower Than H1N1

Unlike past respiratory illnesses, pregnancy does not seem to put women at risk of worse outcomes from COVID-19, according to the first 6 weeks of births to women in the UK during the COVID-19 era.

"When we actually looked at our data in nonpregnant women of the same age, the outcomes look to be pretty similar for [mothers]" with COVID-19, study coauthor Marian Knight, MBChB, DPhil, professor of maternal and child health at the University of Oxford, United Kingdom, said. The data, currently available on a pre-print database, also suggest that more severe outcomes are more likely in later pregnancy, which Knight said should support guidance that women in the third trimester be vigilant with physical distancing, masking, and hand hygiene to avoid acquiring SARS-CoV-2 in the first place. The paper has not been peer-reviewed and therefore the findings should be taken as preliminary until it is accepted. The data may also temper concerns raised in early case reports on miscarriage and other poor outcomes. "Most of the publications in pregnancy have been case series, and we've really had no idea how representative they are of all the women affected," she said. "These results can be reassuring" that poor outcomes may indeed be less common than the current literature suggests.

Endowment Announced

As part of an ongoing commitment to the advancement of respiratory care, Dräger announced that it has granted the American Respiratory Care Foundation (ARCF) a $50,000 endowment to support the Craig D Smallwood Early Investigator Fellowship. This newly established program, which will be announced at the 2020 American Association for Respiratory Care (AARC) International Congress in Orlando, honors the late Craig D Smallwood, PhD, RRT, who died unexpected at the age of 36 in April 2020. Dr Smallwood was an innovative, collaborative and productive researcher who served as a mentor to up-and-coming researchers in the field of respiratory care. Before his untimely passing, he was working on the design and deployment of respiratory assist devices for treatment of COVID-19 patients in the developing world. The ARCF fellowship is designed to provide the chosen fellow with financial, experiential and mentoring resources; thereby continuing Dr Smallwood’s tradition of promoting the role of the respiratory therapist in supporting neonatal and pediatric research. “We are very pleased to receive such generous support from Dräger, a forward-thinking company that understands the importance of mentorship in respiratory care,” said ARCF Chairman Michael Amato. “This unique program remembers the valuable contributions of Dr Smallwood, and will help prepare the next generation of researchers. By supporting the ARCF, Dräger is investing in the future of respiratory care.” Dräger is one of several companies in the respiratory industry to establish an endowment to the ARCF for the purpose of creating research fellowships. This program recognizes the ongoing need for effective clinical research specifically to support neonatal and pediatric patients. “Technology advancement, innovation and new clinical practices require research,” said President and CEO for Dräger in North America, Lothar Thielen. “Establishing an annual award to support neonatal/pediatric research fosters an environment of collaboration and continues the scholarly work necessary to advance and improve patient outcomes.”

Birth Rates Fall

The number of babies born in the US hit the lowest level in more than three decades in 2019, continuing a five-year downward trend, according to a new federal report. The report on provisional data from the Centers for Disease Control and Prevention indicates notable birth and population measures reached record lows in 2019. American women, for example, are now projected to have about 1.71 children over their lifetimes – down 1% from 2018 and below the rate of 2.1 needed to exactly replace a generation. "The (total fertility) rate has generally been below replacement since 1971 and consistently below replacement since 2007," the report says. In all, the US saw nearly 3.75 million births last year, down 1% from 2018 and the lowest level since 1985, according to the CDC. Births fell among women of most races, though they rose 3% for women who were Native Hawaiian or other Pacific Islander. Births remained largely level for Hispanic women. The US birth rate – which measures the number of births per 1,000 women and girls between the ages of 15 and 44 in a given year – sat at 58.2 in 2019 for another record low, according to the report. Its continual decline has been driven in part by a 73% plummet in the teen birth rate since 1991. That rate fell another 5% in 2019, reaching 16.6 per 1,000, the report notes. Birth rates also fell for women in their 20s and early 30s in 2019, but rose for women in their early 40s. "The rate for (women 40 to 44 years old) has risen almost continuously since 1985 by an average of 3% per year," the report says. Trends in birth outcomes also continued in 2019: The preterm birth rate rose for the fifth year in a row, reaching 10.23%, while the cesarean section rate fell to 31.7% from 31.9%. The low-risk C-section rate – measuring C-sections among women giving birth for the first time to a single baby, born after reaching term and in the head-first position – fell to 25.6% from 25.9%. The federal government's Healthy People goals say the low-risk C-section rate should be no more than 24.7% by 2020, and there's significant variation in C-section rates at the state and county levels.

Astarte Medical has an upcoming webinar, Preterm Infant Growth Assessment — Metrics That Matter

Featured Speakers: Dr Tanis Fenton and Dr Bill Hay on June 10, 2020, at 4:00 p.m. ET.
Topics of discussion will include:

• Findings from their recent publication - Extrauterine growth restriction" and "postnatal growth failure" are misnomers for preterm infants published March 25, 2020
• Definition of Extrauterine Growth Restriction (EUGR)
• Proper growth assessment and metrics that matter

Registration and Complete Event Details: https://astartemedical.webinarninja.com/live-webinars/327916/register

Study Shows Reduced Risks

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk–based nutritional products, announced that a subgroup analysis of a randomized, multicenter clinical study demonstrated a fivefold reduced risk of certain serious complications and death, and greater increases in head circumference, which suggests better brain growth, using Prolacta’s 100% human milk–based fortifier in place of cow milk–based fortifier among preterm infants. All study infants were fed only their mother’s milk, in addition to either human- or cow-milk-based fortifiers and were treated in a neonatal intensive care unit (NICU). The analysis was conducted to more closely compare feeding protocols used in NICUs today and represents one of the only studies of preterm infant feeding protocols ever to directly compare fortifiers made from either human milk or cow milk among infants whose only other source of enteral nutrition is milk from their mothers.   The study, “Preterm Infants Fed Cow's Milk–Derived Fortifier Had Adverse Outcomes Despite a Base Diet of Only Mother's Own Milk,” was published in Breastfeeding Medicine and found the following health outcomes among preterm infants who received Prolacta’s 100% human milk–based fortifiers:

• 13% greater head circumference gain, which is used as a measure of brain growth
• 5.1-fold reduced risk of surgery and death due to necrotizing enterocolitis (P = 0.014)
• Comparable weight and length gain

“Those fed the human milk–derived fortifier were significantly advantaged in terms of a reduced incidence of morbidity,” wrote the study authors, who were led by Alan Lucas, MD, Professor at the Institute of Child Health, University College London in the United Kingdom. Many studies, including the original study2 from which this analysis was derived, compared human- and cow-milk-based fortifiers in infants fed various combinations of human milk (from either their mother or donors) and cow milk–based preterm formula. However, many healthcare professionals prefer direct clinical comparison for the specific effects of a 100% human milk–based fortifier vs a cow milk–based fortifier, since avoidance of exposure to cow-milk proteins is one likely reason 100% human milk–based fortifiers are so beneficial. Based closely on the methods by which preterm infants are currently being fed in NICUs worldwide, the subgroup analysis focused specifically on the 114 infants who received their mother’s milk plus either:

• Prolacta’s 100% human milk–based fortifier (82 infants)
• Cow milk–based fortifier (32 infants)

“The original Sullivan study has been criticized for not representing current NICU feeding practices which prioritize mother’s milk or donor human milk over cow milk–based preterm formula. The Lucas subgroup analysis removed that variable to provide a head-to-head comparison of human- vs cow-milk-based fortifiers mixed with a base of mother’s milk. It demonstrated, with statistical significance, that the cow-milk-based fortifiers alone lead to adverse outcomes, while preterm infants fed Prolacta’s human milk–based fortifier achieved the same positive results including fewer complications as demonstrated in the original study. This subgroup analysis also found additional improvements in head growth, which is an indirect measure of brain growth, in the infants receiving Prolacta’s fortifier,” said Melinda Elliott, MD, Chief Medical Officer, Prolacta Bioscience.

Neotech Products Re-releases Disposable Ocular Exam Kit

Back by popular demand, Neotech Products is excited to announce the re-release of the Ocular Exam Kit Disposable Speculum and Depressor. “After numerous requests by clinicians for a disposable alternative, we made the decision to bring back this innovative and unique product,” said Executive Director of Sales & Marketing, Judy McCrary. Conceived by Dr David Sami, Pediatric Ophthalmologist, our specula and depressor was developed for single use per eye. This helps to reduce the risk of cross contamination and eliminate the need to re-sterilize. “One of the many benefits of the Neotech Ocular Exam Kit is that due to its disposability, it does not incur the normal re-sterilization costs that standard exam kit tools do,” McCrary said. The Ocular Exam Kit is disposable, sterile, and ready to use. Its unique speculum is designed to lock in place with eyelid pressure, allow unrestricted view, and open and close with ease. The speculum is available in two sizes—Neonatal and Standard. The two-sided depressor features an innovative texture intended to gently grip the conjunctiva.

Utility Device Holder with C-clip Attachment Available

Neotech Products unveiled the NeoHug Utility Device Holder is now available with a C-clip attachment for IV poles. “We had increased interest in departments that didn’t have a surface to adhere the suction cup [of the original NeoHug] to. Our incredible engineering team at Zewski Corp got to work creating this new attachment for the NeoHug. Their skilled team took the challenges in needing an adaptation and made them into the reality,” said Sara Dimmitt, Manager of Business Development. The new C-clip attaches to most IV poles, snaps on and off, and features a ribbed design to minimize slipping. “The C-clip is great for pediatrics and mobile patients to hold tubing or needed supplies,” Dimmitt said. NeoHug is also available with a large suction cup that attaches to most smooth, flat surfaces. It offers a strong hold that withstands heat and humidity, and features a tab for easy removal. Like the C-clip, the suction cup allows for repeated repositioning with no adhesive. The playful chimp design adds some color to your unit, five bright colors in fact! The bendable arms are designed to hold a variety of lightweight items, making it ideal for holding pacifiers, suctioning tips, tape, tubing, and more!

Observational Registry Moves to Next Phase

Mallinckrodt, a global biopharmaceutical company, announced that its observational registry comparing the safety and effectiveness of INOmax (nitric oxide) gas, for inhalation, in term and near-term neonates to that in preterm neonates with pulmonary hypertension (PH) was ended early due to achievement of the pre-specified primary outcome measure, non-inferiority (95 percent confidence interval: -0.0021, 0.1158, with a pre-defined margin of -0.1452). The decision was made following the second planned interim analysis at 75 percent enrollment. The company intends to share the results of this study in an appropriate scientific forum soon. INOmax is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. The safety and efficacy of INOmax in premature neonates has not been evaluated by the US Food and Drug Administration. 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. "Mallinckrodt is extremely pleased to be able to end this registry based on positive findings much earlier than anticipated," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "The real-world data provided by this registry underscores our commitment to continue to expand upon the body of scientific knowledge on treatment of vulnerable patient populations, such as premature infants with pulmonary hypertension." The observational registry study was conducted across 31 sites and was designed to evaluate the effectiveness and safety of INOmax in 168 premature neonates vs term and near-term neonates (1:1) with PH. The interim analysis assessed 54 premature and 84 term and near-term neonates and demonstrated that the trial achieved the significance level for non-inferiority. Evaluation of significant improvement for each neonate is based on at least a 25 percent decrease in oxygenation index (OI) or surrogate OI (SOI) during the INOmax treatment period. No drug-related serious adverse events were attributed to study drug. At the time of the interim analysis, there were 17 adverse events of special interest reported in 16 subjects, most of which were in the preterm group and deemed not related or unlikely related to study drug. INOmax has been on the market in the U.S. 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.

Neonatal Intensive Care proud to add Dr Ruben Dario Restrepo to its Editorial Advisory Board

Los Angeles, CA — Health journal Neonatal Intensive Care today announced the addition of Dr Ruben Dario Restrepo to its respected Editorial Advisory Board. Dr Restrepo is Coordinator of Research Division of Respiratory Care with UT Health San Antonio, Department of Respiratory Care, San Antonio, Texas.

“We’re proud to add someone of Dr Restrepo’s caliber to the Editorial Advisory Board of Respiratory Therapy,” said Steve Goldstein, Publisher of Neonatal Intensive Care. “With the spread of COVID-19, the field of Respiratory Therapy is more important now than ever and our publication is dedicated to offering cutting-edge insight into how health-care professionals are handling this crisis. Dr Restrepo will help us achieve that mission.”

Dr Restrepo is a Fellow of the American Association of Respiratory Care (FAARC) and the American College of Chest Physicians (CHEST), a Distinguished Teaching Professor and Distinguished CHEST Educator, and has been inducted into the Kenneth I. Shine Academy of Health Science Education, and received the Regents Outstanding Teaching Award.

“I am a very passionate educator,” said Dr Restrepo. “Teaching respiratory care at a global and interprofessional level has been my motto from the time I started teaching.”

COVID-19 Global Disease Dynamics and Hands-on Treatment Best Practices

Join us on April 9 at 8 a.m. PST for an important webinar report by Pr. Luciano Gattinoni on managing critical parameters of ventilatory support for COVID-19 patients. As a researcher and a mentor to clinicians across Europe, Pr. Gattinoni has a unique, comprehensive perspective on COVID-19 care. In this webinar, he will share his observations of the disease as well as basics on how to ventilate a COVID-19 patient. A live Q&A session will follow this webinar presentation.

WHAT WILL BE COVERED
• Differences between COVID-19 and ARDS lung dynamics
• Criteria for non-invasive support versus mechanical ventilation
• Suggested ventilator settings
• The right moment to wean

WHO SHOULD ATTEND
Intensivists, ICU Clinicians, Respiratory Therapists, Respiratory Experts, Anesthesiologists, Hospitalists and Physicians and Healthcare Providers caring for COVID-19 patients.

Pr. Luciano Gattinoni is currently a Guest Professor at the University of Göttingen (Germany). He is world-renowned for inventing the “Extracorporeal CO2 Removal” technique in acute respiratory failure, promoting the “baby lung” model of lung injury (1980’s) and identified mechanical power variables to assess risks of mechanical ventilation (2016). He has previously served as President for the Italian National Society of Anesthesia and Intensive Care, the European Society of Intensive Care, and the World Federation of Societies of Intensive and Critical Care Medicine.

His research focuses on the pathophysiology and treatment of acute respiratory failure, sepsis, and acid base disorders. He has published more than 400 research articles in peer-reviewed journals. He is Honorary Member of the German Society of Anesthesiology and Intensive Care, Fellow of the Royal College of Physicians, and was awarded with the Life Time Achievement Award by the American Society of Anesthesiology, the American Society of Critical Care Medicine and the European Society of Intensive Care and the French Society of Intensive Care. Visit gehealthcare.com for more.

Two NICU Items to Remember

To keep an eye on NICU visitor temperature readings, NOVAMED USA provides an easy answer with ACCUTHERM Forehead Liquid Crystal Temperature Indicators. Simply adhere to the forehead and within 15 seconds, core body temperature is indicated. Safe for even the most sensitive skin and can be worn up to 48 hours. Not made of natural rubber latex. Offered 100 pcs/ box for $95. www.novamed-usa.com For further inquiries: Email info@novamed-usa.com. Avoid NICU out-of-stock scenarios with NEOTEMP Skin Temperature Sensors from NOVAMED USA. This reliable USA manufacturer/distributor offers a complete range of sensors to match GE/Ohmeda, Draeger/AirShields, ATOM Medical and International Biomedical incubators and radiant warmers. Call upon their neonatal specialists to assist in matching your specific requirements. For further inquiries: Email neonatal@novamed-usa.com or visit www.novamed-usa.com.

NICU Comms Tools Available

Keriton is offering 6-months of access to our patient communication tools. Learn more: www.keriton.com/special_for_nicus. Keep families connected to the NICU with realtime, HIPAA-compliant push notifications, chat and photos: Private, two-way chat between staff and families; Broadcast updates to all families with push notifications; Send families secure photos of their babies; Easy to turn-on for WOWs and desktops too.

Hy-Tape International’s COVID-19 Response

Hy-Tape International wanted to let you know what we’re doing in response to the Novel Coronavirus (COVID-19) outbreak to protect our staff and customers. We’re following federal, state, and local government health advice to make sure our customers and our colleagues stay safe and we are putting all the necessary measures in place to ensure this advice is followed by everyone. This means that we have staggered our workforce to keep our numbers lower. That being said, we appreciate your patience when placing orders. There are many steps throughout the process that may experience delays that are out of our hands. Presently we are well stocked, orders are going out on, or close to on time. Our spirits are high, we know that everyone working hard to help during these times are doing their best, and we will continue to serve our clients, answer calls, and move ahead to do our part. Thank you for your continued support and if you have any questions or concerns, please call us 1-800-248-0101.

Non-traditional means of PEEP generation utilized in conjunction with the LifePulse Jet Ventilator

Given the current COVID-19 Pandemic, hospitals may be faced with inadequate numbers of conventional ventilators due to the reallocation to other patient units. Clinicians may need to utilize non-traditional methods for PEEP and Mean Airway Pressure generation for use with the LifePulse Jet Ventilator.

Recommendations are below for these optional applications. We encourage you to call the hotline at 800-800-4358 (HFJV) should this situation arise. Alarms will only be activated by the LifePulse Jet Ventilator in all of the following set up scenarios. It is essential to respond to all alarms identified on the LifePulse HFJV. Use the PEEP display on the LifePulse HFJV to monitor PEEP. The following options are only recommended to be used on stable patients, as defined by the attending physician. Filter the exhaled gas in any of the following set up scenarios. Always provide proper humidification in any of the following set up scenarios. Option One: Traditional Invasive CPAP. (Diagram 1) Provide a blended gas source to a heated wire conventional ventilator circuit. At the interface on the distal end of the expiratory limb, utilize a PEEP valve. This set up would allow for the filtration of the exhaled gases, located before the PEEP valve. In addition, this option could also utilize a T-Piece Resuscitator to function as the PEEP valve and offer intermittent positive pressure breaths given via the clinician. NOTE: The position for some PEEP valves, i.e., vertical versus inverted, will affect the PEEP value displayed on a pressure manometer. NOTE: During testing, we noticed an audible vibration when using a PEEP valve and filter together. This noise did not affect the functionality of this option. Option Two: Traditional Invasive Bubble CPAP. (Diagram 2) Provide a blended gas source to a heated wire circuit using a flowmeter. Place the distal end of the circuit in either sterile water or acetic acid bath, to generate the desired CPAP level. NOTE: Bubbles generated in the water column caused pressure fluctuations, which contributed to discrepancies between measured PEEP on the Jet and the set PEEP. Our recommendation, for this application specifically, is to use another pressure manometer for monitoring PEEP. Option Three: Utilizing a T-Piece Resuscitator. (Diagram 3) It is strongly suggested to utilize flows between 8-10 liters per minute. It is essential to heat and humidify the inspiratory gas by utilizing the manufacturer's recommended heated wire circuit. Option Four: Utilizing a T-piece circuit without the Driver. (Diagram 4) Similar to Option Three. In this option, there is a Tpiece, with a PEEP valve, placed before the humidifier to set the desired Peak Inspiratory / Pop-Off Pressure. To deliver a manual breath, the T-piece resuscitator, located on the expiratory limb near the filter, is occluded by the clinician. WARNING: Having a PEEP Valve / Pressure Pop-Off, located at the humidifier, is critical in safely applying this option. The methods described in this Bulletin are valid only for the duration of the Declared Public Health Emergency. These alternate methods of providing PEEP have not been cleared through the FDA. These methods are only to be used if a conventional ventilator is not available to provide PEEP or mean airway pressure. Although Bunnell Inc. has performed bench studies to confirm effectiveness and safety, full clinical validation with all set-ups has not been completed. If the patient is positive for Coronavirus or is suspected to be positive, we recommend the use of an expiratory filter or a traditional conventional ventilator.

St. Luke's University Health Network One of the First in the World to Pilot Masimo SafetyNet

Masimo announced that St. Luke's University Health Network (SLUHN) is one of the first institutions worldwide to use Masimo SafetyNet to monitor in-hospital patients, as the network seeks innovative solutions to care for the surge of patients infected by COVID-19. Masimo SafetyNet is an innovative, economically scalable cloud-based patient management platform designed to help clinicians care for patients remotely in hospital settings and in non-traditional settings and circumstances. The telehealth solution uses a tetherless, wearable single-patient-use sensor to monitor patients with clinically proven Masimo SET pulse oximetry, and is designed to help manage the surge in COVID-19 patients while maintaining the safety of other patients and providers, allowing hospitals to expand patient remote monitoring into alternative care spaces, including overflow locations, emergency recovery facilities, and home care settings. Aldo Carmona, MD, St. Luke's Senior Vice President of Clinical Innovation and Chairman of the Department of Anesthesia and Critical Care, said, "This technology is game-changing in light of the crush of demand on our hospitals during this COVID-19 pandemic. With this wearable device, we can create temporary, pop-up respiratory monitoring units as needed to meet the changing patient volumes and track employees' health in their homes if they have been exposed to COVID-19, the flu, or any other serious illness." Designed to track the blood oxygen saturation and respiration rate of patients who are hospitalized or quarantined at home, Masimo SafetyNet combines tetherless SET pulse oximetry with a proprietary remote data capture and surveillance platform accessible from a patient's Android or iOS smartphone or smart device. Monitoring key physiological data can help provide clinicians with an accurate snapshot of a patient's systemic health and facilitates awareness of the need for rapid execution of treatment decisions that can be life-saving. Patients are provided with a multi-day supply of single-patient-use sensors and access to the Masimo SafetyNet mobile app. With clinical feedback from St. Luke's led by Dr. Carmona and from University Hospitals led by Dr Peter Pronovost, Masimo SafetyNet has been designed for easy, intuitive use to provide customized, interactive CarePrograms that align with expert guidance on COVID-19. Monitoring data collected by the sensor is shared with the patient’s smartphone using a secure Bluetooth® connection. Twice daily, or as directed, the CareProgram can be configured to actively notify patients to answer questions such as, "are you having trouble breathing?" and "what is your temperature?", and pushes these responses along with the monitoring data to clinicians for evaluation. CarePrograms are fully customizable to accommodate each institution's protocols, each patient’s needs, and any changes in COVID-19 guidance – and can be updated through the cloud by providers even after being deployed, for maximum flexibility as situations evolve. In addition to COVID-19 CarePrograms, Masimo SafetyNet can be configured for more than 150 other CarePrograms for use with COPD, heart failure, oncology, and other patients.

On March 30, patients at St. Luke's University Health Network Bethlehem diagnosed with COVID-19 were outfitted with Masimo SafetyNet. Non-COVID-19 patients are also being monitored with this system in general medical-surgical units. St. Luke's plans to use the Masimo SafetyNet tetherless sensor and cloud-based surveillance system to monitor upwards of 2,000 hospitalized patients and lower acuity cases in the home. These may also include staff and patients who are quarantined at home with the virus. "Our patients at St. Luke’s have the most sophisticated and reliable respiratory monitoring available anywhere," Carmona says. "We know that continuous physiologic monitoring with Masimo’s Patient SafetyNet improves outcomes and saves lives. The ability to extend that capability to patients in non-traditional settings and at home during this crisis with Masimo SafetyNet is transformative. Only through our relationship with Masimo could this have been possible."

Joe Kiani, Founder and CEO of Masimo, said, "Masimo is proud to be able to work with St. Luke’s to help protect the health and safety of medical professionals and the patients they serve during this global pandemic."

Prolacta Reassures Hospitals of the Safety of Its Human Milk-Based Nutritional Products Amid COVID-19

Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, notified hospital customers of the safety, quality, and continued supply of its human milk-based nutritional products. Prolacta’s products are used by neonatal intensive care units (NICUs) throughout the world to address the nutritional crisis of prematurity. “We realize these are uncertain times and there are many questions surrounding the coronavirus. We are providing hospitals with the latest scientific data needed to make informed decisions,” said Scott Elster, president and CEO of Prolacta Bioscience. “We also want to reassure these dedicated clinicians that the pandemic will not affect our commitment to supply their premature infants with life-saving nutritional products.” The US Centers for Disease Control and Prevention (CDC), the Union of European Neonatal and Perinatal Societies (UENPS), and the European Center for Disease Prevention and Control (ECDC) have all issued statements either that SARS-CoV-2 (coronavirus) does not appear to be present in breastmilk and/or that breastmilk does not appear to be a source of disease transmission. Currently, data from China show an absence of detectable coronavirus in breastmilk. Chen et al. studied lactating mothers with coronavirus. Breastmilk of six of those mothers was tested for the presence of SARS-CoV-2. The virus was not found in any of the milk specimens tested. Kam et al. looked at breastmilk from one mother with coronavirus and this testing also failed to show the presence of the virus. Prolacta exceeds all state and federal regulations for human milk quality and surpasses the quality and safety standards of all currently operating milk banks. All Prolacta products are pasteurized using time and temperature profiles defined by the US Food and Drug Administration (FDA) in its Pasteurized Milk Ordinance (PMO) to ensure destruction of pathogens. Prolacta’s pasteurization process has been independently validated using the same robust pathogen inactivation studies used in the biologics industry. This validation demonstrates that Prolacta’s pasteurization provides appropriate bacterial killing and viral inactivation including enveloped viruses. Coronavirus is an enveloped virus. Studies of other epidemic coronaviruses, such as the virus responsible for the 2003 SARS epidemic and the virus responsible for the 2012 MERS outbreak, demonstrate that pasteurization is highly effective in inactivating these viruses. These studies were done in diverse carrier media such as plasma products and various animal milks in which the virus was found during epidemic infection. Only human milk products manufactured with the FDA-defined pasteurization process, such as Prolacta’s, are clinically proven to be safe and improve health in the NICU. No published clinical data show similar results using human milk products treated by any other method. Prolacta operates the first and only pharmaceutical-grade manufacturing facilities for the testing and processing of human milk. Its two facilities have standard ISO-7 and ISO-8 cleanrooms totaling nearly 21,100 square feet. Prolacta modeled its stringent quality and safety protocols on those used in the plasma and blood industries. Prolacta has developed, validated, and implemented 19 donor milk screening tests to ensure the safety of its human milk-based nutritional products. Prolacta also has implemented the world’s first nucleic acid amplification test (NAAT) capable of directly detecting the presence of infectious disease-causing pathogens and bacteria in donated breastmilk. Since 2018, all donor milk received by Prolacta has been tested using NAAT. “All Prolacta products, including pasteurized and nutrient-standardized donor milk, are manufactured in the same manner and undergo the same quality and safety protocols,” said Elster. “We are maintaining a full inventory of finished product, as well as raw materials, and have multiple shipping partners to ensure deliveries continue as planned. Our team remains available to handle orders and any issues that arise.”

Device With Improved Oxygen Saturation Gets FDA Clearance

Device maker Masimo announced that RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry have received FDA clearance for improved oxygen saturation (SpO2) accuracy specifications for neonatal patients (<3 kg). The updated RD SET sensors’ SpO2 accuracy specifications have improved significantly, from 3% to 1.5% ARMS (at 1 standard deviation), in conditions of motion and no motion, providing clinicians with even greater confidence when monitoring the oxygenation status of neonates. With this clearance, the improved performance specifications, which were incorporated into RD SET sensors for patients >3 kg in 2018, are now available to all patient populations in the United States. Masimo’s SET pulse oximetry has been shown in more than 100 independent and objective studies to outperform other pulse oximetry technologies – even before the revisions that achieved the improved accuracy specifications – providing clinicians with increased sensitivity and specificity to help them make critical patient care decisions. Crucially for newborn health, SET has been shown to help clinicians reduce severe retinopathy of prematurity in neonates3 and in multiple studies, including the largest critical congenital heart disease (CCHD) study to date, to improve CCHD screening in newborns. In addition to offering improved accuracy, RD SET sensors are designed to enhance patient comfort, optimize clinician workflows, and help hospitals meet green initiatives. The sensors are lightweight and have a flat, soft cable with smooth edges, so that they lie comfortably on a patient’s hand or foot. In particular, RD SET NeoPt sensors with Velaid SofTouch use little to no adhesive, facilitating quick but gentle application and repositioning on the fragile skin of newborns and pre-term babies. RD SET sensors also feature an intuitive sensor-to-cable connection, while their lightweight design results in up to 84% less waste and their sleek, recyclable packaging reduces storage and shipping space. Joe Kiani, Founder and CEO of Masimo, said, “We’re delighted to announce the latest result of our continued innovation in our foundational SET pulse oximetry. We have long been dedicated to helping improve the lives of neonatal, infant, and pediatric patients, and this clearance significantly furthers that mission. Thanks to the brilliance and dedication of our engineers and the continuing support of our customers, we’ve been able to once again raise the standard for pulse oximetry performance. Even though no one has been able to create pulse oximetry that outperforms SET, we have not allowed that to stop us from continuing our pursuit of perfecting pulse oximetry.”

Nihon Kohden Launches New Ventilator System

Nihon Kohden, a US market leader in precision medical products and services, announced the launch of its new NKV-550 series ventilator system that offers a full suite of applications necessary in a critical care setting for patients of all ages – from neonate through adult. The NKV-550, introduced for the first time at the annual American Association for Respiratory Care Congress 2019 in New Orleans, is an innovative ventilator that features an integrated touchscreen, intuitive user interface, and onscreen help functions. The NKV-550 was developed to seamlessly transition between invasive ventilation, noninvasive ventilation and high-flow oxygen therapy, allowing clinicians to respond to a patient’s respiratory support needs without having to change devices. “Every product we bring to market is designed to simplify workflow for clinicians and benefit patients,” said Yasuhiro Yoshitake, president and CEO of Nihon Kohden America. “We saw a tremendous need in the respiratory market for a comprehensive ventilator that could respond to any patient situation while also providing excellent usability using modern technology.” The NKV-550 is a unique ventilator to offer Protective Control, a feature that uses a second graphic user interface placed outside the isolation room of a contagious patient who is under mechanical ventilation. The respiratory therapists and clinicians can view the ventilator monitors and alarms, adjust ventilation settings and alarm settings, and audio pause the alarm sound, through the second graphic user interface outside the isolation room, as long as the patient is within the sight of the clinician through the room’s glass window. When managing a patient who has a communicable disease case and is in isolation, this feature protects both the clinician and the patient because respiratory therapists and clinicians will not lose valuable minutes donning protective gowns, gloves and masks before responding to the needs of an infectious patient. This minimizes a potential hazard many healthcare workers face. An estimated 42 healthcare workers per million employed die each year from infections acquired at work. The NKV-550 was created based on the lung protective approach to ventilation and features the Gentle Lung suite of applications to provide clinically relevant, easy-to-use tools for the open-lung approach to ventilation. The ventilator offers highly customizable screen configurations enabling the ventilator to fit into your paradigm rather than require you adapting to it. The app-based design provides guided processes to help create a more streamlined, systematic way for clinicians to optimize care of their ventilated patients. The NKV-550 also offers on-screen help tools to walk clinicians through critical ventilator troubleshooting. Founded in Japan in 1951, Nihon Kohden is a leading manufacturer, developer and distributor of medical electronic equipment, with subsidiaries in the US, Europe and Asia. The company’s products are now used in more than 120 countries, and it is the largest supplier of electroencephalography products worldwide.

Device Gets a Hug from Company

Neotech Products announced the release of their newest product, the NeoHug Utility Device Holder. The genesis for the NeoHug came after Neotech received several similar ideas. The product design team then came together to create a device that was easy to use, useful for clinicians, and playful. “The original idea was a simple strap with suction cup and then a similar idea was submitted to Neotech. Thanks to the help of our engineering design team at Zewski Corporation, they came up with the creative animal design. After some production design challenges, we’re very excited to bring this product to market,” said Neotech President Craig McCrary. The NeoHug attaches to most smooth surfaces utilizing a large suction cup for strong hold and easy removal, while also holding under heat and humidity. The suction cup allows for repeated repositioning with no adhesive. The playful chimp design adds some color to your unit with five bright colors to choose from. The bendable arms are designed to hold a variety of lightweight items, making it ideal for holding pacifiers, suctioning tips, tape, and more. “Seeing the reaction from the clinicians has truly made developing this product worthwhile. It’s exciting to have a very functional product come to market and knowing it’s a device that can bring smiles wherever it’s being used,” McCrary said.

New Product a Solution to Meet Updated Guidelines

Neotech Products is announced the release of their newest product, the NeoHeart ECG Pad. The NeoHeart ECG Pad was designed by a clinician as a solution to meet the new NRP guidelines for neonatal resuscitation by providing an all-in-one ECG pad that can be deployed in seconds, not minutes. “In a newborn resuscitation, time is everything! What I love about the new Neotech NeoHeart ECG Pad is that with one touch you can apply all 3 ECG leads securely and out of the way so that everyone can focus on stabilizing the infant and not the equipment,” said Kathi Salley-Randall, MSN, RNC, CNS, NNP-BC. The NeoHeart ECG Pad features a 3-in-1 pre-wired electrode array and pre-measured sensor position for clinician ease of use. Its one-touch application makes it ideal for use in the delivery room. The NeoHeart ECG Pad was engineered for back application, allowing the chest to remain exposed. “As most of us know, it is extremely difficult to assess heart rate in the first critical minutes of a sick newborns life. Palpation and auscultation of heart rate in the delivery room are not accurate and more importantly take valuable time and hands away from more critical tasks. The new NeoHeart ECG Pad gives accurate heart rate readings in seconds (not minutes) so that we can quickly assess the newborn's needs and effectiveness of interventions without having to stop to check the heart rate manually,” Salley-Randall said.

Oximetry Device Cleared by the FDA

Masimo announced that O3 Regional Oximetry has received FDA clearance for use on neonatal and infant patients (<10 kg). O3 may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With this expansion of the O3 platform, the benefits of monitoring with O3 are now available to patients of all ages, from neonates to adults. O3, which uses near-infrared spectroscopy (NIRS) to monitor the regional hemoglobin oxygen saturation of blood (rSO2) on both sides of the brain, may be particularly helpful in providing insight into neonatal patient status because neonatal pathology is often brain-related. In neonates, O3 provides reliable measurement with a 3% ARMS trending accuracy specification.

O3 sensors are available in three sizes, for adult (≥40 kg), pediatric (≥5 kg and <40 kg) and now infant and neonatal (<10 kg) patients. With its smaller size and flexible design, the neonatal sensor is designed to fit easily and comfortably on the delicate foreheads of tiny patients. O3 is available as a Masimo Open Connect (MOC-9) module for the Root Patient Monitoring and Connectivity Platform. Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root's plug-and-play expansion capabilities allow clinicians to simultaneously monitor with O3 and other measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry, providing clinicians with expanded visibility of neonatal oxygenation status. Additional modalities available on Root include advanced rainbow noninvasive measurements such as total hemoglobin (SpHb), SedLine brain function monitoring (available for adult patients), NomoLine capnography, and more – all via an easy-to-interpret, customizable display. Using Root in combination with Masimo Patient SafetyNet or Iris Gateway, monitoring data from O3 can be automatically charted in electronic medical records (EMRs).

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 neonates and infants in mind. These patients were not an afterthought. This focus has paid off for these young patients: SET pulse oximetry has helped clinicians reduce the incidence of severe retinopathy of prematurity (ROP) in neonates and improve critical congenital heart disease (CCHD) screening in newborns. O3 Regional Oximetry, with its ability to help clinicians accurately track cerebral oxygen saturation, will hopefully have a similar impact. We are happy to be able to bring O3's advanced capabilities and accuracy to the neonatal patient population."

NeoConnect at Home OTC Reusable ENFit Syringe Line Unveiled

NeoMed is excited to unveil NeoConnect at Home, a reusable portfolio of ENFit syringes that do not require a physician’s prescription. As a leading ENFit solution provider, NeoMed is dedicated to making it easier than ever for home patients to access the ENFit syringes they need. The NeoConnect at Home line of ENFit syringes is the first of its kind to be available over-the-counter (OTC) AND FDA 510(k) cleared for reuse. Ideal for patients in non-clinical and homecare settings, each syringe may be hand washed and reused up to 20 times by one user when cleaned per the cleaning instructions provided with the syringe. Reusability allows for a cost-effective and eco-friendly alternative to single use ENFit syringes. The syringe portfolio will be available in four convenient sizes (3 mL, 6 mL, 12 mL and 60 mL). Complete with a durable polypropylene plunger and silicone O-ring gasket, the syringes will feature clear barrels with easy-to-read black markings and will be offered in consumer-friendly case quantities. The product line will be available for purchase through retail and online stores, DME’s and homecare companies in the fall of 2019. ENFit is the registered trademark of the Global Enteral Device Supplier Association (GEDSA) and is commonly used to identify ISO 80369-3 compliant connectors. ENFit connectors help reduce the risk of enteral tube feeding misconnections and improve patient safety. GEDSA encourages manufacturers to introduce enteral devices with ENFit connectors, and healthcare facilities to adopt feeding systems with ENFit connectors as soon as possible. “The development of our NeoConnect at Home line of OTC reusable ENFit syringes is a direct result of feedback from customers concerned about ENFit syringe access and availability. Not only have we made our syringes more accessible, we’ve added value by ensuring they can be reused. It is our hope that ENFit syringe OTC availability and reusability will make enteral feeding and medication delivery hassle-free and cost-effective,” said Marc Waldman, Vice President of Business Development at NeoMed. “We are proud to be the first in the industry to offer reusable ENFit syringes that are available without a prescription. We believe that this innovation will improve ENFit device access and advance the worldwide adoption and implementation of safer enteral connectors,” remarked NeoMed President Aaron Ingram.