News

Early Bilirubin Screening Identifies Neonates Needing Phototherapy

OCT 30 2024

Approximately 1% of neonates born to O+, antibody-negative mothers qualified for phototherapy within 24 hours of birth, with most identified through routine bilirubin screening. The visual detection of jaundice was not a common trigger for starting phototherapy. Researchers reviewed the birth records of 6098 neonates (≥ 35 weeks’ gestation) born to O+, antibody-negative mothers, to identify those qualifying for phototherapy within 24 hours of birth. Neonates were screened to determine if they needed phototherapy on the basis of visual jaundice detection and 24-hour bilirubin screening (transcutaneous bilirubin or total serum bilirubin measurements). Phototherapy was initiated based on total serum bilirubin, according to the 2004 guidelines from the American Academy of Pediatrics. ABO hemolytic disease was defined by a positive direct antiglobulin test in offspring with blood type A or B born to O+, antibody-negative mothers. Neonates with total serum bilirubin within 3 mg/dL of exchange transfusion thresholds were identified as those with severe hyperbilirubinemia requiring potential intravenous immune globulin treatment. From the entire cohort, 1% qualified for phototherapy within 24 hours of birth. Early bilirubin screening identified 83% of neonates needing phototherapy at a median postnatal age of 24 hours, whereas 17% were identified using visual detection of jaundice at a median postnatal age of 13 hours. A majority of newborns (81%) who required phototherapy within 24 hours of birth were ABO incompatible and had a positive result on a direct antiglobulin test, highlighting ABO hemolytic disease as a key cause of early neonatal hyperbilirubinemia. Seventeen neonates had total serum bilirubin levels within the exchange transfusion thresholds; 14 of these cases were identified using 24-hour bilirubin screening, and three were identified using early jaundice detection. The total serum bilirubin levels in six of the 17 neonates exceeded the exchange transfusion thresholds, with four cases identified using bilirubin screening. "These data suggest that visual assessment of jaundice is of limited value as a surveillance tool to consistently detect hyperbilirubinemia meriting treatment at ≤ 24 hours after birth," the authors of the study wrote. "Our findings support routine birth hospitalization bilirubin screening and suggest screening no later than 24 hours may be beneficial," they added.

Live Rotavirus Vaccine Safe for Newborns of Biologic-Treated Moms With IBD

OCT 30 2024

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD). No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months postvaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology. The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Calgary, Alberta, Canada. "Despite the well-established safety and effectiveness of non-live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal," Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination. "These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects," she said.

Infant's Rash Defies Most Likely Diagnoses

OCT 30 2024

Clinicians should consider zinc deficiency in premature infants having an erythematous, scaly, sharply demarcated rash that does not respond to treatments for the most likely diagnoses. Investigators report the case of a 5-month-old infant born prematurely, at 26 weeks of gestation, brought to the emergency department with a rash. The rash consisted of erythematous, scaly, crusted skin lesions of the head, neck, and perineal and genital areas; other symptoms included irritability and diarrhoea. The initial differential diagnosis included eczema, allergy, and infection. The infant's history was noteworthy for exclusive breastfeeding, chronic lung disease of prematurity, recent bronchiolitis, and psoriasis in a paternal aunt. The rash was non-responsive to systemic antibiotics (for suspected superinfected eczema), exclusion of dairy from the mother's diet (cow's milk protein allergy), topical emollients and steroids (eczema), topical miconazole and oral nystatin (fungal infection), oral aciclovir (viral infection), and repeated oral co-amoxiclav (impetigo and cellulitis). The infant was receiving prophylactic iron and multivitamins, phosphate supplements, and alginic acid. Results of cultures, skin swabs, and bloodwork were normal/negative, except for mild thrombophilia and a low alkaline phosphatase level. The infant was started on zinc supplements based on clinical suspicion of deficiency, resulting in rapid resolution of symptoms, including near-complete resolution of the rash within 1 week. When results for a pre-supplementation zinc level became available, they showed a value of 1.8 μmol/L (normal range, 5-21.5 μmol/L); the level after 1 week of supplementation was 11 μmol/L. "Consider nutritional zinc deficiency in a premature infant presenting with an erythematous scaly, well demarcated circumoral, anogenital, and acral skin changes unresponsive to treatments of common differential diagnoses. Risk factors…include prematurity [and] exclusive breastfeeding especially with a deficient or restrictive maternal diet," the authors wrote. "Start zinc supplementation before confirmation with a low zinc level as test results can take time. In children unable to maintain zinc levels after stopping supplements, genetic testing for primary acrodermatitis enteropathica should be considered," they concluded.

US Med-Equip, Sentec Team Up to Support Clinicians Nationwide

OCT 18 2024

As hospitals across the United States navigate the challenges of delivering patient care in increasingly high-acuity environments, a new partnership between US Med-Equip (USME), a leading provider of medical equipment rentals and services, and Sentec, a global leader in respiratory monitoring technology, is set to help more clinicians with real-time insights into the conditions of critically ill respiratory patients, including newborns in Neonatal Intensive Care Units (NICUs). Under the new partnership, USME added Sentec's transcutaneous monitoring (TCM) devices as part of its extensive portfolio of life-saving medical equipment. Sentec’s TCM devices provide continuous, non-invasive monitoring of a patient's carbon dioxide levels and oxygen saturation to help clinicians make better-informed decisions in real-time — particularly vital in the care of patients, such as those in the NICU, where precise monitoring of respiratory function is crucial. In addition to transcutaneous monitoring, Sentec's Intrapulmonary Percussive Ventilation (IPV) technology will also be available through this partnership. IPV therapy supports the front-line care of critically ill respiratory patients as a management tool to restore lung function and mobilize secretions. By adding both TCM and IPV technology into USME's rental and service offerings, healthcare providers gain greater access to non-invasive equipment often preferred by clinicians, especially in intensive care units, emergency departments, and during transport of critically ill patients. "Partnering with US Med-Equip enables us to better support our shared hospital customers dedicated to providing the highest quality care for respiratory-compromised patients, especially during periods of high patient census and urgent capital needs,” Sentec CEO Bob Cormier said. This partnership reflects a growing trend in healthcare, where the integration of advanced technology with on-demand service is increasingly essential. Under the new partnership, US Med-Equip, known for its rapid response and high-quality service, is offering Sentec’s devices with the level of support that has made them a trusted partner for hospitals nationwide. "Sentec shares our unwavering commitment to supporting clinicians in delivering exceptional patient care," Greg Salario, CEO of USME, said. "This collaboration enhances our ability to provide healthcare partners with access to the most advanced patient monitoring solutions, precisely when they need them most."

ART Linked With Congenital Heart Defects in Newborns

OCT 16 2024

The rate of congenital heart defects is higher in newborns conceived using assisted reproductive technologies (ART) than in newborns conceived without assistance. This finding comes from a population-based cohort study led by Dr Nona Sargisian, a gynecologist at the University of Gothenburg, Gothenburg, Sweden, and colleagues, which was published in the European Heart Journal. The researchers analyzed more than seven million results of all live-born children in Denmark, Finland, Sweden, and Norway between 1984 and 2015. They found that congenital heart defects occurred more frequently in the ART newborn group (1.85%) than in naturally conceived newborns (1.15%). The study also revealed that the risk for congenital heart defects in multiple births is higher than in single births, with and without the use of ART. However, the result that congenital heart defects occur more often in ART newborns remained significant when comparing single births from both groups (1.62% vs 1.11%). Dr Barbara Sonntag, a gynecologist at Amedes Fertility Center in Hamburg, Germany, referred to a "clinically relevant risk increase" with a relatively low prevalence of the condition. "When 1000 children are born, an abnormality occurs in 18 children after ART, compared with 11 children born after natural conception," she told the Science Media Center. Sonntag emphasized that the risk is particularly increased by a multiple pregnancy. A statement about causality is not possible based on the study, she said. But multiple pregnancies are generally associated with increased risks during pregnancy and for the children. The large and robust data set confirms long-known findings, said Dr Georg Griesinger, medical director of the fertility centers of the University Medical Center Schleswig-Holstein in Lübeck and Manhagen, Germany. The key figures can be found in single births, he explained. "Among single births conceived by ART, the rate of severe congenital heart defects was 1.62% compared with 1.11% in spontaneously conceived single births, an increase in risk by 1.19 times. For severe heart defects, the rate was 0.31% in ART single births, compared with 0.25% in spontaneously conceived single births." The increased risks are consistent with existing literature. Therefore, the current study does not reveal any new risk signals, said Griesinger.

Beyond Air Provides LungFit PH System to hospital

SEP 27 2024

Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, is proud to announce the deployment of its groundbreaking LungFit PH system to the US Naval Hospital Guam. This partnership, made possible through collaboration with TrillaMed, marks a significant advancement in the neonatal critical care unit, offering enhanced care for newborns in need of respiratory support. The LungFit PH system is an innovative device designed to generate Nitric Oxide (NO) from room air and deliver NO for the treatment of persistent pulmonary hypertension in neonates (PPHN), a condition that affects the lungs and heart of newborns. The system provides a safe, efficient, and user-friendly solution to address critical respiratory conditions, ensuring that the hospital’s youngest and most vulnerable patients receive the highest standard of care. Key Features of the LungFit PH System: Portable and compact design, making it ideal for intensive care settings; advanced nitric oxide generating technology with no need for high-pressure cylinders; rapid response for improved oxygenation in neonates with PPHN; easy integration into existing hospital infrastructure. “We are honored to support the US Naval Hospital Guam in their mission to provide top-tier neonatal care,” said Steve Lisi, CEO of Beyond Air. “Through our partnership with TrillaMed, we are able to extend the reach of our LungFit PH, delivering critical solutions to the healthcare community. This collaboration is a testament to our commitment to advancing neonatal care and improving patient outcomes.” The US Naval Hospital Guam serves as a critical care provider for the military community in the region. More than 17,000 active-duty military personnel and family members currently are stationed on Guam, which is expected to increase by 2,500 in the next two years. The US Naval Hospital Guam delivers an average of 315 babies per year, with that number expected to rise to 487 births by 2033. The introduction of the LungFit PH system underscores the hospital’s dedication to utilizing state-of-the-art technologies in neonatal care, ensuring military families have access to the latest in respiratory treatment options.

More Than 50% of Level III & IV NICUs in US Used Prolacta's 100% Human Milk-Based Products to Help Reduce Necrotizing Enterocolitis

SEP 25 2024

Prolacta Bioscience announced a significant milestone in premature infant nutrition. The company's human milk-based nutritional products have been used by more than 50% of Level III and Level IV neonatal intensive care units (NICUs) in the US in 2024 to care for the most vulnerable premature infants – those born weighing less than 1250 g (2.75 lb). The milestone signifies progress in neonatal care and the crucial role human milk plays in reducing complications, including the life-threatening intestinal disease, necrotizing enterocolitis (NEC). Over the past 17 years, Prolacta's 100% human milk-based nutritional products (made from donor breast milk) have become an option, over the use of cow milk-based nutrition, for premature infants in the NICU born weighing less than 1250 g. The announcement comes during NICU Awareness Month, when professional and parent organizations are raising awareness of the nutritional standards in NICUs. Leading advocates for premature infants and their families support the adoption of human milk-based nutrition in the NICU, including: the National Black Nurses Association, Association of Women's Health, Obstetric and Neonatal Nurses, NICU Parent Network, Project NICU, and Once Upon a Preemie, Inc. "The use of Prolacta's fortifiers and formulas in NICUs across the country represents a significant advancement in neonatal care and recognition of the vital role that human milk-based nutrition plays in the survival and long-term health of extremely premature infants," said Melinda Elliott, MD, FAAP, practicing neonatologist and chief medical officer for Prolacta. One in 10 babies are born prematurely and nearly 1 million die each year worldwide, according to the World Health Organization. A recent meta-analysis, "Association of Fortification With Human Milk Versus Bovine Milk-Based Fortifiers on Short-Term Outcomes in Preterm Infants—A Meta-Analysis," found a 50% reduction in mortality among preterm infants fed human milk-based nutritional fortifiers, versus cow milk-based fortifiers. A growing body of clinical evidence demonstrates the short- and long-term health benefits to critically ill, premature infants. Compared to cow milk-based products, an Exclusive Human Milk Diet (EHMD) with Prolacta's 100% human milk-based nutritional fortifiers, has been clinically proven in numerous clinical studies to: lower mortality and morbidity, reduce risk of necrotizing enterocolitis (NEC), reduce incidence of feeding intolerance, achieve adequate growth, reduce incidence of bronchopulmonary dysplasia (BPD), reduce incidence of retinopathy of prematurity (ROP), reduce late-onset sepsis incidence, and evaluations, improve long term outcomes such as neurodevelopment, shorten stays in the neonatal intensive care unit (NICU), reduce hospital costs. NICU Awareness Month is celebrated every September to raise awareness for the critical-care NICUs that care for premature and medically fragile newborns. For more information about Prolacta Bioscience, visit prolacta.com.

Weight Loss Surgery Before Pregnancy Tied to Smaller and Premature Infants

SEP 13 2024

The type of weight loss surgery women undergo before becoming pregnant may affect how much weight their children gain in the first three years of life, suggests a study presented at ENDO 2024, the Endocrine Society's annual meeting in Boston, Mass. Researchers found children born to women who underwent the bariatric procedure known as sleeve gastrectomy before they became pregnant gain more weight per month on average in the first three years of life compared with children born to women who had the less common Roux-en-Y gastric bypass weight loss procedure. Maternal obesity is a risk factor for obesity in children. Women are more likely to conceive following weight loss procedures, but less is known about the early growth of the children born after pre-pregnancy weight loss procedures. Sleeve gastrectomy and Roux-en-Y gastric bypass are two of the more common types of weight loss surgery, also known as bariatric and metabolic surgery. These surgeries result in sustained weight loss and improve the body's metabolism in the majority of patients. In vertical sleeve gastrectomy (also called gastric sleeve surgery), a surgeon removes most of the stomach, leaving only a banana-shaped section that is closed with staples. By removing a part of the stomach that makes hormones that drive hunger, this procedure also decreases appetite. In gastric bypass, the surgeon divides the stomach into two parts, sealing off the upper section from the lower. The surgeon then connects the upper stomach directly to the lower section of the small intestine. This creates a shortcut for food, bypassing part of the stomach and the small intestine. Skipping these parts of the digestive tract means the body absorbs fewer calories and nutrients. The researchers examined the weight and length of offspring born after pre-pregnancy weight loss procedures in the first three years of life. The study used data from 20,515 deliveries over three years, of which 450 had pre-pregnancy weight loss procedures. Among the mothers who underwent weight loss surgery, 57% had sleeve gastrectomy and 41% had Roux-en-Y gastric bypass. Long-term weight and length data were available for about half of the babies in each group. The researchers found there was no difference in birth weight among the babies born after weight loss surgery. The pace of weight gain was higher in those born after pre-pregnancy sleeve gastrectomy compared to those born following Roux-en-Y gastric bypass, while adjusting for several other variables including pre-pregnancy body mass index.

New Urgency Over Pregnant Women With Epilepsy

SEP 13 2024

Pregnant women with epilepsy are at higher risk for severe maternal, foetal, and neonatal outcomes, including death, according to the largest study to date of 4.5 million deliveries in five Nordic countries. This study was a prospective cohort of 4,511,267 deliveries, of which 35,283 were to mothers with epilepsy and 4.475 million were to mothers without epilepsy in Denmark, Finland, Iceland, Norway, and Sweden (1996-2017). The study also was of antiseizure medication use (n = 16,240) vs non-use (n = 19,043) among mothers with epilepsy. The primary outcomes were a composite of severe maternal outcomes and a composite of severe perinatal (foetus and neonatal) outcomes. Findings were adjusted for maternal age, parity, birth year, number of chronic conditions, among other confounders. There was a 23% increase in composite maternal death and morbidity (adjusted odds ratio [aOR], 1.23; 95% CI, 1.16-1.31) among mothers with epilepsy vs those without. The three greatest maternal risks were for mortality (aOR, 3.86; 95% CI, 1.84-8.10), cerebrovascular accidents (aOR, 5.81; 95% CI, 4.27-7.89), and severe mental health conditions (aOR, 1.81; 95% CI, 1.50-2.19). Adverse perinatal outcomes included a 44% increase in composite perinatal death/severe neonatal morbidity (aOR, 1.44; 95% CI, 1.37-1.52), including a 48% increase in composite severe neonatal morbidity (aOR, 1.48; 95% CI, 1.40-1.56), and an 18% increase in stillbirth (aOR, 1.18; 95% CI, 1.00-1.40) compared with outcomes among mothers without epilepsy. Antiseizure medication use vs non-use by women with epilepsy was associated with a higher risk for neonatal death (aOR, 2.40; 95% CI, 1.44-4.00), cerebrovascular accidents (aOR, 1.99; 95% CI, 1.13-3.50), and perinatal death (aOR, 1.40; 95% CI, 1.03-1.89). With regard to specific antiseizure medication vs non-use, the likelihood of severe maternal morbidity was increased for valproate (aOR, 1.67; 95% CI, 1.26-2.23), carbamazepine (aOR, 1.46; 95% CI, 1.14-1.87), and oxcarbazepine (aOR, 1.53; 95% CI, 1.08-2.17).

How Two Nurses Turned Late-Night Advice Into Big Business

AUG 30 2024

Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta-based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night. It was the mid-1990s, and theirs was the only practice in town that offered on-call nurse responses around the clock. Hunter and Walker alternated work-from-home shifts, chatting with many of the practice's families. The pair answered the same questions from panicked parents over and over. And they found themselves bridging the gap between medical advice and parenting advice when supporting families. "Parents were calling us at 2 in the morning with all kinds of things they were worried about, and that's where Moms on Call was born," Walker said. A few decades later, Walker and Hunter turned that experience, empathy, and expertise into a thriving business. Moms on Call is often referred to as the "instruction manual for babies," and the two nurses have consulted with more than 10,000 families. Along the way, they've sold more than a million copies of multiple books, created a deep well of online resources, and trained others in their techniques. So how did they do it? Walker and Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn't quite a book at first. "It was a folder we printed off the computer with those questions coming in," Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed. "What if we just go to the [patient's] house and help them figure that out?" Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Hunter's swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person. The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a "definitive line" that they wouldn't be discussing "major medical issues." The physicians they worked with began recommending their services. Walker jokes that they didn't know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting. Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them. It was a solution to the problem of the 15-minute office visit.

Masimo delivers donation of Stork units

AUG 27 2024

Masimo, a global leader in innovative monitoring technologies used in top hospitals, and March of Dimes, the leading non-profit organization fighting to improve health outcomes for all moms and babies, are launching a partnership to support new parents with babies in the Neonatal Intensive Care Unit (NICU). Between 9 to 13 percent of babies born require a stay in the NICU due to complex medical needs, and many babies born preterm, with birth defects, or with severe health complications spend their first days in the NICU. Through this partnership, Masimo will support March of Dimes’ NICU Family Support program, which helps over 50,000 families nationwide as they navigate the NICU experience and the transition from hospital to home. As part of the partnership, Masimo is committed to donating $100,000 of Masimo Stork units, a revolutionary, FDA-cleared smart home baby monitoring system designed to deliver peace of mind, to families with the greatest need for support, through March of Dimes’ NICU Family Support program. The NICU Family Support program offers family education, staff training on family-centered care, and an improved experience for parents with a baby in the NICU across more than 70 US partner hospitals. “Going home is an exciting and long hoped for milestone for new parents, but it is often one of the most overwhelming times for NICU families. Stork, which is powered by the same Masimo SET sensor technology that’s been trusted in NICUs for decades, was developed to help parents have more peace of mind by keeping them informed about their baby’s health when caring for them at home,” said Joe Kiani, Founder and CEO of Masimo. “Together with March of Dimes and their premier NICU Family Support program, we aim to improve health outcomes for the youngest and most vulnerable patients and provide additional support to new parents as they bring their little ones home from the hospital.” Stork leverages the same Masimo SET pulse oximetry technology developed over 35 years ago and is the only device with over-the-counter FDA clearance for use on neonates the day they come home. Stork monitors a baby’s oxygen saturation level (SpO2), pulse rate (PR), and skin temperature, and notifies caregivers with visual and audible alarms if a baby’s SpO2 or PR readings fall outside of preset ranges. "March of Dimes is pleased to announce our partnership with Masimo Stork – a collaboration rooted in our mutual commitment to empowering NICU families through knowledge, compassion, and support,” said Kara Gilardi, Associate Vice President, March of Dimes NICU Family Support. “Stork’s sponsorship will support the evidence-based programs we provide that make a world of difference for families in the NICU and the providers who care for them.” The partnership will also feature key activation moments throughout 2024 and 2025, including NICU Awareness Month programs, donation matching events highlighting Masimo's commitment to supporting families of NICU babies, and video releases that honor NICU families and provide vital resources to assist them in their transition home.

Preterm Infant Study Details Improved Growth and Reduced NICU Costs

AUG 21 2024

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill and premature infants, announced today that the journal Nutrients has published a study demonstrating that proactive use of its human milk-derived cream, Prolact CR, resulted in improved infant growth, decreased malnutrition rates, and reduced hospital costs. The feeding protocol with proactive use of Prolact CR for very low birth weight (VLBW) infants demonstrated: Improved overall z-score weight change from birth to discharge within malnutrition severity (p = 0.0061). Specifically, severe malnutrition declined from 3.3% to 2.7%, and moderate malnutrition declined from 36.6% to 8.3%.1; reduced need for higher-calorie (28 kcal/oz) fortifiers, decreasing from 43% to 14%; An average product cost savings of $2,968 per infant by using less human milk-based fortifiers. The study, "Proactive Use of a Human Milk Fat Modular in the Neonatal Intensive Care Unit: A Standardized Feeding Protocol," compared two groups of VLBW infants receiving Prolacta's Exclusive Human Milk Diet (EHMD). One group had Prolact CR added only if poor weight gain occurred, while the other received Prolact CR proactively when transitioning off parenteral nutrition and lipids were discontinued, providing an additional 2 kcal/oz to account for the caloric reduction. "Every NICU is continually looking to improve health outcomes and find cost savings. Through this study, we demonstrated that we were able to achieve both," said the study's lead author, Amanda Salley, MS, RD, CSP, LN, with UChicago Medicine/AdventHealth, Hinsdale Hospital, at the time of the study. Made from 100% human milk cream, Prolact CR is a human milk caloric fortifier intended for use in the neonatal intensive care unit (NICU), added to mother's own milk or donor breast milk to provide essential calories and help premature infants achieve adequate growth without substantially increasing feeding volume. "These findings underscore the importance of optimizing protocols for each individual infant so we can improve their growth," said Melinda Elliott, MD, FAAP, chief medical officer at Prolacta. "Not only do individualized feeding protocols support healthier growth, this approach means fewer complications for vulnerable infants and significant cost savings for hospitals."

Helping save the lives of premature babies

AUG 8 2024

Medical advances over the past several decades have given hospitals the ability to save younger and younger premature newborns. Yet most hospitals don’t try—and parents often aren’t aware of what’s possible or that other hospitals, even just a few miles away, might offer their newborns a fighting chance. Doctors are now capable of saving the lives of babies born at 22 weeks and, in rare cases, a week earlier, with improved techniques to help tiny lungs develop and protect fragile skin and organs. Hospitals with extensive experience resuscitating extremely premature babies report survival rates as high as 67% for babies born at 22 weeks. Some US hospitals aren’t sufficiently equipped or capable of pulling off the new advances. Others have chosen not to offer the care, saying it is likely to fail, is expensive—typically more than $100,000 a child, and sometimes much more—and subjects tiny, fragile infants to needless pain and the risk of long-term disabilities. Instead, they often provide comfort care: wrapping the newborn in a blanket, placing it on the mother’s chest and sometimes giving medicines to ease the child’s final moments. The difference can be a matter of life or death for the roughly 8,000 infants born between 22 and 24 weeks gestation in the US each year. Doctors agree that babies born at 25 or 26 weeks can and should be treated as long as they don’t have other complications, while those born at 20 weeks or less are too small to save. In between is a “gray zone,” as doctors call it, where newborns’ fate can depend on which hospital happens to be delivering. “Through my career of more than 40 years now we’ve seen the limit of viability move about a week every 10 years,” said Dr. Edward Bell, a neonatologist at the University of Iowa hospital, a leader at treating extremely premature babies. “We’ve done what we thought was never going to be biologically possible.” Still, saving a child born at 22 weeks is difficult. Their mouths and airways are small, making it difficult to intubate them. Their outer layer of skin is often only a few cells thick. Their guts are thin and can develop holes. They have trouble regulating their body temperature and often fall prey to hypothermia. They usually need months of treatment. The University of Iowa hospital offers parents the option of either active treatment to try to save the baby or comfort care to those born at 22 weeks. The vast majority choose active treatment. Out of those it tries to keep alive, 62% end up going home. The hospital has even graduated several 21-weekers from its NICU. In Japan and Sweden, treating babies born at 22 weeks is more common, and in some hospitals, every single 22-weeker is treated. Some 63% of babies born at 22 weeks and treated in Japan survived long enough to be discharged from the NICU and go home, according to a study published this year in the BMJ, a UK medical journal. In Sweden, the rate was 58% survival until the first birthday, according to a paper published in the journal JAMA in 2019. Rates are generally lower at US hospitals that offer the neonatal treatment, according to doctors and studies, though some report comparable rates. At Children’s Minnesota, about 60% of its 22-weekers go home after NICU stays. The USA Health Children’s & Women’s Hospital in Mobile, Ala., which has been treating 22-weekers for 24 years, saves 67%. Despite the progress, less than half of American NICUs—45%—provided treatment to babies at 22 weeks, according to a study of a sample of hospitals published this year in the journal JAMA Network Open. Some hospitals simply can’t. NICUs are classified into four levels, depending on the type of care they can provide, with only Levels 3 and 4 equipped to treat babies born before 32 weeks. Even some of the higher level NICUs aren’t caught up on what is now possible or how best to care for such small babies.

Magnesium Sulfate Reduces Cerebral Palsy in Preterm Birth

JUN 28 2024

An international research collaboration conducting a comprehensive review of studies from across the globe has reaffirmed that magnesium sulfate, a medication widely used during pregnancy, significantly reduces the risk of cerebral palsy and death for very preterm babies. The study, recently co-published in Obstetrics & Gynecology, was based on six trials involving 5917 women, pregnant with their 6759 babies. It compared the effects of magnesium sulfate with placebo, finding strong evidence for the brain protecting benefits of magnesium sulfate for very preterm infants. One of the lead researchers, Dr Emily Shepherd, a Postdoctoral Research Fellow and NHMRC Emerging Leadership Fellow at SAHMRI, says the results are significant for prematurity research, with magnesium sulfate being one of only two proven prevention strategies for cerebral palsy. "Our review now demonstrates with high certainty, that magnesium sulfate, administered to women at risk of very preterm birth, can reduce the risk of cerebral palsy and death for their children up to two years of age," Dr Shepherd said. All trials included women in preterm labor or with expected or planned preterm birth before 34 completed weeks of their pregnancies. Magnesium sulfate was administered intravenously but various treatment protocols were used across the trials. Importantly, the review showed that medicating with magnesium sulfate doesn't raise the risk of preterm babies or their mothers incurring other short or long-term complications.

Antibiotics in Pregnancy Linked to Increased Risk for Infantile Seborrheic Dermatitis

JUN 28 2024

Maternal in utero exposure to antibiotics was associated with an increased risk for infantile seborrheic dermatitis (SD) regardless of the mother's history of SD, but this association was not as strong for childhood-onset SD. The findings come from a large analysis of data from the United Kingdom that was presented during a late-breaking abstract session at the annual meeting of the Society for Investigative Dermatology. SD is a common skin disease "that shares similarities with atopic dermatitis or atopic eczema as both are prevalent inflammatory skin diseases that can present with a chronic relapsing, remitting course," the study's corresponding author Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, said in an interview. "Like atopic dermatitis, the pathophysiology of seborrheic dermatitis is thought to be complex and involves an interplay between genetics, immune dysregulation, and alterations in lipid composition and the skin microbiome, among others." In a previous study, she and colleagues showed that exposure to antibiotics both in utero and during the first 90 days of life increases the risk for atopic dermatitis (AD) in children, with risk being highest with exposure to penicillin even among children whose mothers did not have a history of AD. For the current study, the researchers drew from a large electronic medical records database in the United Kingdom to perform a prospective cohort analysis of mother-child pairs that used proportional hazards models to examine the association between maternal in uteroantibiotic exposure and SD in the child. The population included 1,023,140 children with linked maternal data who were followed for a mean of 10.2 years, which amounts to more than 10-million-person years of data. At baseline, the mean age of mothers was 28 years, 3% had SD, 14% had AD, and 51% of the children were male. In unadjusted analyses, mothers with SD were more likely to receive an antibiotic during pregnancy than those who did not have SD (odds ratio [OR], 1.42; 95% CI, 1.39-1.46). In addition, maternal in uteroexposure to any antibiotic was associated with an increased risk for infantile SD (OR, 1.70; 95% CI, 1.65-1.76) but less for childhood-onset SD (OR, 1.26; 95% CI, 1.20-1.32). "This effect changed little after adjustment and was still observed if mothers with SD and their babies were excluded," the authors wrote in their poster abstract. Any penicillin exposure during pregnancy increased the likelihood of a child having SD (OR, 1.54; 95% CI, 1.50-1.59), with the greater risk for infantile SD (OR, 1.70; 95% CI, 1.65-1.76) than for childhood-onset SD (OR, 1.25; 95% CI, 1.18-1.32). "The trimester of the in uteropenicillin exposure did not seem to affect the association with SD," the authors wrote. The risk was also increased with cephalosporin exposure but was less for sulfonamides and not for childhood-onset SD. "We observed that antibiotic exposure in utero was primarily associated with an increased risk of infantile SD regardless of the mother's history of SD, but this association was not as strong for childhood-onset SD," Chiesa Fuxench said. "This would suggest that in utero exposure to antibiotics, particularly penicillin, may have its greatest effect on the colonization of skin microbiota in the newborn period leading to the development of infantile SD. Aside from seeking to improve our understanding of the pathophysiology of SD, our findings also suggest that infantile SD and childhood-onset SD may be separate entities with different risk factors, a hypothesis that needs to be further studied."

Human Milk-Based Fortifiers Cut Mortality Rate by 50% in Preterm Infants, Independent Study Shows

JUN 25 2024

An independent study published in the journal Nutrients found a 50% reduction in mortality among preterm infants fed human milk-based nutritional fortifiers. The meta-analysis assessed short-term outcomes, comparing human milk-based fortifiers (HMBFs) with cow milk-based fortifiers (CMBFs) in premature infants fed a human milk diet of mother's own milk (MOM) or donor human milk (DHM). The analysis comprised data from four clinical studies involving 681 preterm infants born at <28 weeks of gestation, with a birth weight of <1,500 g. Key findings: Use of a human milk diet with human milk-based fortifiers reduced mortality by 50% compared to a diet with cow milk-based fortifiers (p = 0.03); a trend toward reduced bronchopulmonary dysplasia (BPD) with human milk fortifiers that approached statistical significance (p = 0.05). "The data associates bovine (cow) milk-based fortifiers with a potentially increased risk of death in preterm infants, which makes a reversal possibly necessary," notes the study, led by Radu Galis, MD, neonatologist at Emergency County Hospital Bihor in Romania. While the authors call for additional research, they concluded: "The most important finding of our analyses was the reduction in mortality across all four clinical studies and data sets." The authors also note, "Bovine (cow) milk products have been introduced into neonatal care without a safety consideration or parental verification." "The analysis underscores that human milk-based fortifiers can save lives for the most vulnerable patients," said Melinda Elliott, MD, FAAP, practicing neonatologist and chief medical officer at Prolacta Bioscience. "Over 20 peer-reviewed studies and abundant real-world data from around the globe demonstrate the clinical benefits of human milk-based fortification for extremely premature infants." This meta-analysis was independent of Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill and premature infants. Extensive real-world data affirm that adoption of an Exclusive Human Milk Diet (EHMD) enables critical health improvements for premature infants and major cost reductions for hospitals. Analysis of 2019-2022 data from more than 3,000 patients at 60+ US hospitals found EHMD implementation improved health outcomes and reduced costs, generating a 2.6X dollar-for-dollar return on investment. Similarly, a 2023 peer-reviewed report found EHMD implementation resulted in a 3X dollar-for-dollar return on investment from a reduction in comorbidities and shorter lengths of stay among very low birth weight infants.

Antibiotics in Pregnancy Linked to Increased Risk for Infantile Seborrheic Dermatitis

JUN 14 2024

Maternal in utero exposure to antibiotics was associated with an increased risk for infantile seborrheic dermatitis (SD) regardless of the mother's history of SD, but this association was not as strong for childhood-onset SD. The findings come from a large analysis of data from the United Kingdom that was presented during a late-breaking abstract session at the annual meeting of the Society for Investigative Dermatology. SD is a common skin disease "that shares similarities with atopic dermatitis or atopic eczema as both are prevalent inflammatory skin diseases that can present with a chronic relapsing, remitting course," the study's corresponding author Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, said in an interview. "Like atopic dermatitis, the pathophysiology of seborrheic dermatitis is thought to be complex and involves an interplay between genetics, immune dysregulation, and alterations in lipid composition and the skin microbiome, among others." In a previous study, she and colleagues showed that exposure to antibiotics both in utero and during the first 90 days of life increases the risk for atopic dermatitis (AD) in children, with risk being highest with exposure to penicillin even among children whose mothers did not have a history of AD. For the current study, the researchers drew from a large electronic medical records database in the United Kingdom to perform a prospective cohort analysis of mother-child pairs that used proportional hazards models to examine the association between maternal in uteroantibiotic exposure and SD in the child. The population included 1,023,140 children with linked maternal data who were followed for a mean of 10.2 years, which amounts to more than 10-million-person years of data. At baseline, the mean age of mothers was 28 years, 3% had SD, 14% had AD, and 51% of the children were male. In unadjusted analyses, mothers with SD were more likely to receive an antibiotic during pregnancy than those who did not have SD (odds ratio [OR], 1.42; 95% CI, 1.39-1.46). In addition, maternal in uteroexposure to any antibiotic was associated with an increased risk for infantile SD (OR, 1.70; 95% CI, 1.65-1.76) but less for childhood-onset SD (OR, 1.26; 95% CI, 1.20-1.32). "This effect changed little after adjustment and was still observed if mothers with SD and their babies were excluded," the authors wrote in their poster abstract. Any penicillin exposure during pregnancy increased the likelihood of a child having SD (OR, 1.54; 95% CI, 1.50-1.59), with the greater risk for infantile SD (OR, 1.70; 95% CI, 1.65-1.76) than for childhood-onset SD (OR, 1.25; 95% CI, 1.18-1.32). "The trimester of the in uteropenicillin exposure did not seem to affect the association with SD," the authors wrote. The risk was also increased with cephalosporin exposure but was less for sulfonamides and not for childhood-onset SD. "We observed that antibiotic exposure in utero was primarily associated with an increased risk of infantile SD regardless of the mother's history of SD, but this association was not as strong for childhood-onset SD," Chiesa Fuxench said. "This would suggest that in utero exposure to antibiotics, particularly penicillin, may have its greatest effect on the colonization of skin microbiota in the newborn period leading to the development of infantile SD. Aside from seeking to improve our understanding of the pathophysiology of SD, our findings also suggest that infantile SD and childhood-onset SD may be separate entities with different risk factors, a hypothesis that needs to be further studied."

Product Line Acquired

MAY 31 2024

Respiralogics announces the Asset Purchase of the Children’s Health First Product Line, a Carlsbad, CA company. Respiralogics, a leader in Bubble CPAP and Non-Invasive Respiratory Support of the Newborn, is proud to expand their product portfolio with the StatStrap Neonatal Positioning Strap, Preemie Beenie Poly Lined-Knit Hats and StatStrap Circuit Holder. These quality products fulfill unique niches to help bedside and transport clinicians with ELBW and full-term infants. StatStrap is a single patient-use safety strap set that safely secures and positions newborn infants within an incubator. It easily and securely attaches to the mattress tray of the incubator. StatStrap helps to prevent accidental falls of preterm and term infants receiving care in an incubator. Preemie Beenie is a specially designed Poly-Lined Knit Cap designed for ELBW and Term Infants to aid in their thermoregulation. The snug fit of the soft knit minimizes movement, pressure on the head and color-coded to easily identify the size of the Preemie Beenie StatStrap Circuit Holder assists in keeping tubing’s securely attached to the bed clothes for stability and/or the parent during Kangaroo Care. All products are made in the USA, designed for single patient use and Latex Free. Respiralogics specializes in providing innovative respiratory care products to meet the challenging needs of respiratory patients, especially the most vulnerable preterm infants. To benefit clinicians, we have joined with leading specialty respiratory distributors to provide expert local assistance and the training required for successful implementation of our products. Respiralogics’ complete line of products is available from Respiralogics and our specialty respiratory care distributors. Respiralogics, Respiralogics Logo, Preemie Beenie are trademarks and StatStrap is a registered trademark of Global Respiratory Solutions, Inc.

Maternal Buprenorphine Affects Fetal Breathing

MAY 30 2024

Measures of fetal breathing movement were lower in fetuses of pregnant patients who received buprenorphine, compared with controls, based on data from 177 individuals. The findings were presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists by Caroline Bulger, MD, of East Tennessee State University, Johnson City. Pregnant patients with opioid-use disorder in the community surrounding Johnson City receive medication-assisted therapy with buprenorphine during the prenatal period, Dr Bulger and colleagues wrote in their abstract. The current prenatal program for substance use disorder was established in 2016 based on patient requests for assistance in lowering their buprenorphine dosages during pregnancy, said senior author Martin E. Olsen, MD, also of East Tennessee State University, in an interview. "Buprenorphine medication–assisted treatment in pregnancy is associated with long-term effects on childhood development such as smaller neonatal brains, decreased school performance, and low birth weight"; however, data on the fetal effects of buprenorphine are limited, said Dr Olsen. The current study was conducted to evaluate a short-term finding of the fetal effects of buprenorphine, Dr Olsen said. "This study was performed after obstetric sonographers at our institution noted that biophysical profile [BPP] ultrasound assessments of the fetuses of mothers on buprenorphine took longer than for other patients," said Dr Olsen. The researchers conducted a retrospective chart review of 131 patients who received buprenorphine and 46 who were followed for chronic hypertension and served as high-risk controls. Patients were seen at a single institution between July 1, 2016, and June 30, 2020. The researchers hypothesized that BPP of fetuses in patients receiving buprenorphine might be different from controls because of the effects of buprenorphine. Overall, patients who received buprenorphine were more likely to have a fetal breathing score of zero than those who underwent a BPP for hypertension. A significant relationship emerged between buprenorphine dosage and breathing motion assessment; patients on high-dose buprenorphine were more likely than patients on low doses to have values of zero on fetal breathing motion assessment, and a chi-squared test yielded a P value of .04269. The takeaway for clinical practice is that clinicians performing BPP ultrasounds on buprenorphine-exposed fetuses can expect that these assessments may take longer on average than assessments of other high-risk patients, said Dr Olsen. "Additional assessment after a low BPP score is still indicated for these fetuses just as in other high-risk pregnancies," he said.

Failed IOL Tied to Poor Outcomes for Mom With Diabetes

MAY 30 2024

Approximately one quarter of mothers with diabetes failed induction of labor, and this failure was associated with a range of adverse outcomes for mothers and infants, based on data from more than 2000 individuals. Uncontrolled diabetes remains a risk factor for cesarean delivery, Ali Alhousseini, MD, of Corewell Health East, Dearborn, Michigan, and colleagues wrote in a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. "Identifying and stratifying associated risk factors for failed induction of labor [IOL] may improve counseling and intrapartum care," the researchers wrote in their abstract. The researchers reviewed data from 2172 mothers with diabetes who underwent IOL at a single university medical center between January 2013 and December 2021. They examined a range of maternal characteristics including age, ethnicity, gestational age, medical comorbidities, insulin administration, parity, and health insurance. A total of 567 mothers with diabetes (26.1%) failed IOL and underwent cesarean delivery. Overall, failed IOL was significantly associated with nulliparity (P = .0001), as well as preexisting diabetes compared with gestational diabetes, diabetes control with insulin, maternal essential hypertension, preeclampsia, and polyhydramnios (P = .001 for all). Other factors significantly associated with failed IOL included prenatal diagnosis of fetal growth restriction (P = .008) and placental abnormalities (P = .027).

Human Milk Data Released

MAY 16 2024

Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products, announced that data demonstrating the benefits of Prolacta's Exclusive Human Milk Diet (EHMD) for term infants recovering from gastroschisis repair surgery would be presented at the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) meeting in Milan, Italy, on May 15-18. Gastroschisis is a birth defect in which the intestines, and sometimes other organs, protrude through a hole in the abdominal wall. Infants recovering from gastroschisis repair, especially those with complex disease and comorbidities (e.g., heart or lung disease), require high macronutrient intake for optimal growth.1 Clinicians are increasingly addressing this nutritional need through human milk fortification, which means adding a fortifier to mother's own milk or donor milk to provide additional calories and protein. Until recently, fortification was primarily with cow milk-based fortifiers or formula. These fortifiers have been associated with feeding intolerance and necrotizing enterocolitis (NEC) in preterm infants. The ESPGHAN poster presentation "Human Milk-Based Fortifiers Associated With Improved Growth and Shorter Time to Full Enteral Feeds in Term Infants After Gastroschisis Repair" includes data from a case-control study showing: Term infants who received an EHMD with Prolacta's human milk-based fortifier formulated for term infants achieved full enteral feeds 30 days sooner than infants who received cow milk-based fortifiers or formula (adjusted p = 0.004). The EHMD-fed cohort also experienced higher weight gain velocity (adjusted p = 0.049) and less NEC, with no adverse events reported. "Term infants who require surgery often experience poor growth and significant morbidities when a cow milk-based nutritional fortifier is used," said study lead author Dr Heidi Karpen of the Emory University School of Medicine. "Safe and early postsurgical fortification with an EHMD helps address the specific feeding challenges impacting these infants. It also supports growth and decreases the risk of NEC, which may translate into improved long-term neurodevelopmental outcomes." "This pioneering study for infants with gastroschisis reaffirms the critical importance of optimal nutrition for the growth and health of medically fragile infants," noted Melinda Elliott, MD, FAAP, practicing neonatologist and chief medical officer for Prolacta. "It is well-established in the medical community and in hospitals across the country that Prolacta's EHMD is beneficial for extremely low birth weight premature infants. This data demonstrates that the benefits extend to term infants who require surgery for gastroschisis repair."

Ontario IVF Program Linked to Drop in Multifetal Pregnancies

MAY 16 2024

In Ontario, Canada, the publicly funded fertility program mandated an elective single-embryo transfer (eSET) policy in 2015 for in vitro fertilization (IVF), and this mandate was associated with a decrease in multifetal pregnancy rates, according to a new study. Multifetal pregnancy rates decreased from 29.4% to 7.1% after IVF and from 12.9% to 9.1% after ovulation induction or intrauterine insemination (OI/IUI). "The Ontario publicly funded fertility program was implemented to provide equitable access to fertility treatment. Another goal is to decrease multifetal pregnancy rates after IVF by promoting the transfer of a single embryo at a time," lead author Maria Velez, MD, PhD, associate professor of obstetrics and gynecology and chair of reproductive endocrinology and infertility at Queen's University in Kingston, Ontario, Canada, said. "Multifetal pregnancy can be associated with maternal health complications and preterm birth and in some cases with associated long-term consequences," she said. "While most of the epidemiological surveillance about the outcomes of fertility treatments worldwide is focused on IVF, we also wanted to study the impact of IUI on multifetal pregnancy. We are fortunate to have access to such data in Ontario through ICES." Velez and colleagues conducted a population-based, retrospective cohort study of Ontario administrative health data to analyze all births and fetal reductions from April 2006 through March 2021, looking at differences between unassisted conception, IVF, and OI/IUI. They compared the time before eSET was promoted (2006-2011) with the time after the 2015 mandate (2016-2021), calculating adjusted relative risks (ARRs), population attributable fractions (PAFs), and absolute rate differences.

Clinical Innovator and Educator Joins Editorial Advisory Board of Neonatal Intensive Care and Respiratory Therapy

MAY 8 2024

Kristin King, PhD, CCC-SLP, Vice President of Clinical Education and Research for Passy-Muir Inc., has joined the Editorial Advisory Board (EAB) of Neonatal Intensive Care and also of Respiratory Therapy – bringing along years of expertise in developing clinical innovations that have produced improvements in both industries.

Dr. King brings a wealth of experience to NIC and RT. She is currently on the EAB of the American Speech, Language and Hearing Association (ASHA) Perspectives. She also has received the ACE Award for Continuing Education in four separate years and is ASHA-certified for Clinical Competence in Speech-Language Pathology.

During her time in academia, Dr. King was also awarded a William Webster Endowment Fund Award for Neuroscience Research, and several other grants to support her research in the field of neuroscience, including impacts on language and cognition following traumatic brain injury.

“Disseminating quality clinical/medical information is something I feel strongly about,” said Dr. King.

Dr. King has been an adjunct professor, assistant professor, and clinical instructor at multiple prestigious schools. Since 2008, she has also been a consultant to multiple universities and groups for her expertise in sports concussions and in tracheostomy and speaking valve use, a medical expert witness related to traumatic brain injury in pediatrics and adults, and a published author and national/international speaker on topics related to tracheostomy/mechanical ventilation and speaking valves. Her current role has her providing clinical oversight regarding continuing education, research literature reviews, research, product development, and clinical practice guidelines.

Masimo Receives FDA Clearance

MAY 6 2024

Masimo, a global leader in innovative monitoring technologies currently celebrating its 35th anniversary, announced FDA clearance of Stork, a baby monitoring system that provides alarms to parents or other caregivers, for use with healthy babies 0-18 months of age, without the need for a prescription. The over-the-counter (OTC) version of Stork utilizes the same Masimo pulse oximetry technology that monitors more than 10 million babies in hospitals every year and is used at 9 of the top 10 U.S. hospitals. The FDA-cleared OTC version of Masimo Stork monitors a baby’s key vitals data including oxygen saturation level (SpO2), pulse rate (PR), and skin temperature; crucially, Stork notifies caregivers with visual and audible alarms if a baby’s SpO2 or PR readings fall outside of preset ranges. Stork leverages the same pulse oximetry technology that has been used on babies in the neonatal intensive care unit (NICU) for decades, helping to improve health outcomes for the youngest and most vulnerable patients. Known as Signal Extraction Technology, or SET, this technology has helped clinicians reduce the incidence of neonatal blindness from retinopathy of prematurity and has led to significant improvements in screening newborns for critical congenital heart disease. “Bringing your new baby home from the hospital is exciting, but can be nerve- wracking—and it’s something I remember vividly from when my son was born and required at-home monitoring,” said Joe Kiani, Founder and CEO of Masimo. “I believe that by empowering parents and caregivers with the same Masimo pulse oximetry technology that hospitals have been using on babies for decades, we can help them feel more informed and confident when caring for their baby. It is particularly fitting that we received this clearance and are making this announcement as we celebrate the 35th anniversary of the company I founded with a mission to improve lives everywhere, especially those of the youngest and most fragile among us. Thirty-five years ago I envisioned Stork. I am so proud of our team for Stork – it is a culmination of science and design at its best.” Stork bundles are currently available at major and specialty retailers nationwide and at masimo.com as a non-medical device for general health and wellness purposes. Alongside the FDA clearance, Masimo will make Stork’s new alarm features available to all existing and new Stork users through the Masimo Stork App, in an update scheduled to be released this summer. FDA-cleared OTC Stork bundles will be available for purchase online and at retailers this summer. Masimo’s patented SET sensor technology nests within the Stork boot, which is made from an ultra-soft, medical-grade silicone that conforms gently to the baby’s skin and is available in three sizes to ensure a perfect fit as the child grows. The sensor embedded in the boot is the product of meticulous engineering that harnesses decades of expertise in noninvasive monitoring to detect babies’ SpO2, PR, and skin temperature continuously, with unprecedented accuracy and dependability. Masimo Stork has a sleek, minimalist design that fits seamlessly into any nursery and on the baby’s foot. The Stork Vitals+ bundle includes the boot with sensor that monitors baby’s skin temperature, PR, and SpO2, and a 2K Quad High-Definition (QHD) capable camera with technology supported by the TODA platform from Like Minded Labs. The camera hardware and software architecture are designed to leverage and be compatible with future edge AI-based features, which are in development. The first application of the edge AI technology will be identifying babies who have turned face down. For those who do not require streaming video, or detection via video of babies being face down, the Stork Vitals bundle replaces the camera with a hub, which connects the Stork vital signs sensor/boot to the Stork app, while still allowing parents to hear their baby. Stork also monitors the baby’s room conditions (ambient temperature and humidity). Masimo Stork is 510(k) cleared for OTC use as a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is indicated for spot-checking and continuous monitoring of SpO2 and PR during no motion, motion, and low perfusion conditions in infants and neonates who are 0 to 18 months of age and between 6 and 30 lbs. Masimo Stork OTC is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months of age and between 6 and 30 lbs. Masimo Stork is indicated for use in home environments. Masimo Stork can be used to supplement a caregiver’s decision to seek additional guidance for the care of an infant or neonate. It is not intended to provide notifications for every episode of the unexpected occurrences of elevated or depressed PR or low SpO2; rather, Masimo Stork is intended to provide a notification only when sufficient data are available for analysis. Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider. Masimo Stork is not intended for use with infants and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.

New Trial Deepens Debate Over Late-Preterm Steroids

MAY 1 2024

The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world. As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786). "These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered," the researchers wrote. The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there's debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm. As the study notes, "the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial." But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they're more likely to need hearing aids and eyeglasses.

Infant Microbiome Development Minimally Affected by Diet, but Metabolite Profiles Differ

MAY 1 2024

Diet has only a marginal impact on microbiome development in infancy, although metabolite profiles differ between breast- and formula-fed infants; circadian rhythm of the gut microbiome is detectable as early as 2 weeks after birth. A randomized, controlled interventional trial compared microbiota development in 210 newborns who were exclusively breastfed or received one of four formulas: Un-supplemented formula, Bifidobacterium-supplemented formula, galacto-oligosaccharide (GOS)-supplemented, or formula containing GOSs and bifidobacteria. Exclusively breastfed infants served as a reference group to evaluate the impact of infant formula feeding. Researchers tracked the infants' microbiota and metabolite profiles in response to the different feeding modes via stool samples collected periodically during the first 1-2 years of life. They also made note of the time of day that the stool sample was collected to assess 24-hour oscillations of the microbiome in relation to dietary exposure. Global microbiota assembly of infants is primarily affected by age and less so by diet. All infants showed a gradual increase in gut microbe diversity, and at 24 months, there was no observable difference between the groups. However, gut metabolite profiles differed significantly between exclusively formula-fed and exclusively breastfed infants. None of the supplemented formulas were able to fully recreate the breast milk-related microbial environment. GOS-supplemented formula was more effective at promoting sustained levels of bifidobacteria than formula containing bifidobacteria. Metabolic and bacterial profiling revealed 24-hour fluctuations and circadian networks as early as 2 weeks after birth. Infant microbes maintained circadian rhythms when grown in continuous culture, even in the absence of external light or host cues, suggesting an intrinsic clock mechanism in bacteria. "Our findings warrant the need for further analysis of circadian fluctuations of both bacteria and metabolites and their functional role in contributing to the benefits of infant nutrition," the study authors wrote.

Safety Risks Persist With Out-of-Hospital Births

MAY 1 2024

Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology. In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births). Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births. “Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote. The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35. The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births. “The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.

Company Acquired in New Deal

APR 19 2024

AngelEye Health, the leading technology provider for neonatal and pediatric family engagement services, announced the acquisition of NICU2Home, a company dedicated to empowering families and optimizing care coordination using technology during the journey in the Neonatal Intensive Care Unit (NICU). This strategic acquisition strengthens AngelEye’s commitment to holistic NICU care, expands its solutions for seamlessly connecting families with their infants, and positions the company to streamline the patient experience from admission to discharge for families and clinicians. The acquisition further positions AngelEye Health to address a critical gap in neonatal care coordination by offering numerous benefits, including: Optimized discharge coordination, planning and parent engagement. Improved communication between care teams and families. Reduction of unnecessary days in the NICU. Increased financial efficiency for hospitals. “At NICU2Home, we’ve dedicated more than twelve years to developing and refining our technology, knowing the profound impact it can have on families navigating the complexities of the NICU journey,” said Dr Craig Garfield, co-founder and co-PI at NICU2Home. “Partnering with AngelEye, a leader in the field with a vast existing network, is a game-changer. Together, we have the potential to revolutionize NICU care by empowering families and streamlining the transition home. We’re excited to join forces and make this technology accessible to more families across the country.” AngelEye will leverage the newly combined expertise to further enhance its solutions by integrating NICU2Home with its existing family engagement platform to add a discharge management solution. The integration will provide a single consolidated experience for care teams, healthcare providers and families. The combined solution will be available to new and existing AngelEye customers in phases throughout 2024. “The acquisition of NICU2Home aligns perfectly with our mission to create a more connected and supportive NICU experience for everyone involved,” said Christopher Rand, chief executive officer at AngelEye. “By integrating their innovative family engagement app with our best-in-class camera solutions and data insights, we are creating a comprehensive ecosystem that empowers families, optimizes NICU navigation and ultimately improves the transition to home.” NICU2Home’s user-friendly mobile app, backed by peer-reviewed research from four Chicago-area NICUs, including Northwestern Medicine, provides families with tools to stay informed and engaged throughout their NICU stay. It offers personalized educational content and insights that empower families to understand their child’s condition better and to engage in the care team.

New Trial Deepens Debate Over Late-Preterm Steroids

APR 18 2024

The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world. Researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786). "These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered," the researchers wrote. The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there's debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm. As the study notes, "the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial." But other randomized trials have reached different conclusions, and steroids are not without risks. For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years). The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote "may have influenced the primary outcome." The total number of neonates was 883, including 58 twin pregnancies. There was no significant difference in respiratory distress between groups, "defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life." There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death. Serious adverse events occurred in four neonates but none were linked to the intervention. The study doesn't discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective. "Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial," the authors of the new study reported. "The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97)."

Infant Microbiome Development Minimally Affected by Diet, but Metabolite Profiles Differ

APR 18 2024

Diet has only a marginal impact on microbiome development in infancy, although metabolite profiles differ between breast- and formula-fed infants; circadian rhythm of the gut microbiome is detectable as early as 2 weeks after birth. A randomized, controlled interventional trial compared microbiota development in 210 newborns who were exclusively breastfed or received one of four formulas: Un-supplemented formula, Bifidobacterium-supplemented formula, galacto-oligosaccharide (GOS)-supplemented, or formula containing GOSs and bifidobacteria. Exclusively breastfed infants served as a reference group to evaluate the impact of infant formula feeding. Researchers tracked the infants' microbiota and metabolite profiles in response to the different feeding modes via stool samples collected periodically during the first 1-2 years of life. They also made note of the time of day that the stool sample was collected to assess 24-hour oscillations of the microbiome in relation to dietary exposure. Global microbiota assembly of infants is primarily affected by age and less so by diet. All infants showed a gradual increase in gut microbe diversity, and at 24 months, there was no observable difference between the groups. However, gut metabolite profiles differed significantly between exclusively formula-fed and exclusively breastfed infants. None of the supplemented formulas were able to fully recreate the breast milk-related microbial environment. GOS-supplemented formula was more effective at promoting sustained levels of bifidobacteria than formula containing bifidobacteria. Metabolic and bacterial profiling revealed 24-hour fluctuations and circadian networks as early as 2 weeks after birth. Infant microbes maintained circadian rhythms when grown in continuous culture, even in the absence of external light or host cues, suggesting an intrinsic clock mechanism in bacteria. "Our findings warrant the need for further analysis of circadian fluctuations of both bacteria and metabolites and their functional role in contributing to the benefits of infant nutrition," the study authors wrote.

Safety Risks Persist With Out-of-Hospital Births

APR 18 2024

Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology. In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births). Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births. “Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.

Pessary or Progesterone for Preterm Birth? Advantage Med

MAR 29 2024

A study comparing cervical pessary and vaginal progesterone for the prevention of preterm birth in women with a short cervix of ≤ 35 mm found no significant difference between the interventions for perinatal complications. Among women with a cervical length of ≤ 25 mm, however, pessaries appeared to be less effective at preventing spontaneous preterm birth and adverse outcomes, according to the researchers. Researchers conducted an open-label, randomized controlled trial at 20 hospitals and five obstetric ultrasound practices in the Netherlands. The study included 635 women with healthy singleton pregnancies between 18 and 22 weeks' gestation and an asymptomatic short cervix of ≤ 35 mm. Participants had no history of spontaneous preterm birth. Women were randomly assigned to receive either an Arabin cervical pessary or 200 mg/d vaginal progesterone for ≤ 36 weeks of gestation. The investigators examined a composite measure of adverse perinatal outcomes, including periventricular leukomalacia (grade, > 1), chronic lung disease, intraventricular hemorrhage (grade, III or IV), necrotizing enterocolitis (stage, > 1), sepsis, stillbirth, and death of the baby. Adverse perinatal outcomes occurred in 6% of each treatment group, and the rate of spontaneous preterm birth did not differ significantly between the groups. In a subgroup analysis of 131 patients with a cervical length of ≤ 25 mm, spontaneous preterm birth at < 28 weeks occurred more often in the pessary group (16% vs 4%). Adverse perinatal outcomes also seemed to occur more frequently in the pessary group (24% vs 12%; relative risk, 2.1 [95% CI, 0.95-4.60]), in the subgroup analysis, according to the researchers. "Even though the study was not powered for the subgroup with a short cervix of ≤ 25 mm, results suggest that a cervical pessary should not be used as preventive treatment in this group," the researchers wrote. The study was led by Charlotte E van Dijk, MD, with Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. It was published online on March 12, 2024, in The BMJ.

Pain Exposure Hinders Brain Development in Preterm Infants

MAR 29 2024

Early life pain exposure alters brain development in preterm infants, particularly female infants, according to a new study. The observational cohort study collected and analyzed data from 150 infants born at less than 32 weeks' gestation. Its findings demonstrated that early life exposure to pain affects brain development in very preterm infants. Additionally, the investigators found sex-specific associations between pain exposure and brain development, with female infants experiencing a greater impact on brain connectivity. "Painful exposures are part of lifesaving care for these babies in the neonatal intensive care unit [NICU]. Our work emphasizes that you need to discover new ways to treat pain in preterm babies that promote brain development," study author Thiviya Selvanathan, MD, PhD, a pediatric neurologist at BC Children's Hospital and assistant professor of pediatrics at the University of British Columbia in Vancouver said. The study was published March 15 in JAMA Network Open. With novel imaging technology, researchers can look at the brain in a new way, said Selvanathan. Specifically, "we have the tools to now look at the brain connectome," which maps how connections in the brain are formed, she said. "Instead of looking at individual brain regions, we can now look at how they interact and work together." The study collected MRI data from 80 male and 70 female infants treated at two NICUs in Toronto between 2015 and 2019. All infants were delivered before term, with a median gestational age at birth of 27.1 weeks. Pain was quantified as the total number of invasive procedures in the initial weeks after birth. In the full cohort, the investigators found that greater early life pain was associated with decreased regional connectivity in the neonatal brain, which in turn was associated with worsened neurodevelopmental outcomes at 18 months. The brain's ability to perform both specialized processing and integrating information from various brain regions was hindered. When the researchers stratified the results by sex, they found that greater pain exposure was associated with slower maturation of structural connectivity among female infants only. The finding suggests that these infants may be more vulnerable to the effects of early life pain. However, Selvanathan noted that more research is needed to understand why this sex-specific difference may exist.

COVID Vaccination Protects Against Infection-Related Risks for Stillbirth and Preterm Birth

MAR 29 2024

Previous research has established that there is an increased risk for stillbirth and preterm birth after SARS-CoV-2 infection in pregnancy. A new study finds that the timing of infection during pregnancy matters, with early infection being a worse risk factor than late infection for the two outcomes. The study also finds that COVID vaccination may protect against the infection-related risks for stillbirth and preterm birth. The absolute rate of stillbirth across this cohort of infected pregnant women was very low (0.87%), whereas the rates of early preterm birth (2.05%) and late preterm birth (8.34%) were higher. Vaccination against COVID reduced the risk for stillbirth by a significant 68% compared with no vaccination. Vaccination also reduced the risks for early preterm birth by a non-significant 35% and late preterm birth by a significant 27% compared with no vaccination.

Delaying Inguinal Hernia Repair Beneficial for Preterm Infants

MAR 29 2024

A clinical trial of preterm infants with inguinal hernia found that performing repair after discharge from the neonatal intensive care unit (NICU) resulted in less adverse events than procedures prior to discharge. The study compared the safety of repair before discharge from the NICU with repair after discharge and post-55 weeks gestational plus chronological age (postmenstrual age). The study randomized 338 infants from 39 US hospitals to early or late repair; of the 320 infants who had the surgery, 86% were male, 30% were Black, and 59% were White. The primary outcome was the occurrence of at least one serious adverse event over the 10-month observation period, including apnea requiring respiratory intervention, intubation for more than 2 days, bradycardia requiring pharmacological intervention, or death. Secondary outcomes included a total number of days in the hospital, including the initial NICU stay after randomization, postoperative hospitalization, and any inpatient days due to hospital readmission over the course of the following 10-month period. Infants who underwent late repair had a lower probability of having at least one serious adverse event: 28% had at least one adverse event in the early group vs 18% in the late group. Infants in the late repair group had shorter stays in the NICU after randomization, as well as fewer hospital days following surgery. Late repair provided the greatest benefit to infants with a gestational age younger than 28 weeks and those who had bronchopulmonary dysplasia. Hernias resolved spontaneously in 4% of infants in the early repair group and 11% in the late group, which the authors said supports delaying hernia repair. "The decision to treat the inguinal hernia with an early or late repair strategy likely does not influence the overall duration of the neonatal intensive care unit stay but may hasten the discharge by several days if later repair is chosen, which is likely important to parents and neonatologists." The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Martin L. Blakely, MD, MS, from the Department of Surgery at the University of Texas Health Science Center, Houston, Texas, is the corresponding author.

Many Hospitals in China Stop Newborn Delivery Services as Birth Rate Drops

MAR 29 2024

Many hospitals in China have stopped offering newborn delivery services this year, state-backed news outlet Daily Economic News reported, with industry experts warning of an "obstetric winter" due to declining demand amid a record drop in new births. Hospitals in various provinces including in eastern Zhejiang and southern Jiangxi have in the past two months announced that they will close their obstetric departments. The Fifth People's Hospital of Ganzhou City in Jiangxi said on its official WeChat account that obstetric services would be suspended. Zhejiang's Jiangshan Hospital of Traditional Medicine announced on its WeChat page that its obstetrics business would stop from Feb. 1. The closures come as Chinese policymakers grapple with how to boost young couples' desire to have children as authorities face a growing demographic headache of a rapidly ageing society. China's population fell for a second consecutive year in 2023 as the record-low birth rate and high deaths due to COVID-19 accelerated a downturn that officials fear will have profound long-term effects on the economy's growth potential. The most recent available data from China's National Health Commission showed the number of maternity hospitals dropped to 793 in 2021 from 807 in 2020.

Neonatal Abstinence Syndrome Declined in BC During Pandemic

MAR 29 2024

Neonatal abstinence syndrome (NAS) increased in British Columbia (BC), Canada, prior to the pandemic, then decreased across both urban and rural locations in the first 2 years of the pandemic, new research suggested. The cross-sectional study of more than 514,000 live births showed a relative increase in the NAS rate of 0.5% per month from 2010 to 2020, and a 1.3% per month decrease during the pandemic (June 2020-March 2022). The results were "unexpected because studies have documented increased opioid use during the pandemic," the authors noted. However, the increase was not matched by a continued increase in NAS. The study was initiated because of the "large increase" in opioid overdose deaths during the pandemic, lead author Sarka Lisonkova, MD, PhD, of the Women's Hospital and Health Centre of British Columbia, Vancouver, Canada, said. "This rise was so substantial that it led to discussions about a 'dual epidemic', with deaths from illicit drug overdoses outnumbering those from COVID-19. In light of this situation, we sought to investigate whether there was a corresponding increase in the rates of NAS." The study included registry data for 514,189 live-born infants, of which 2165 had NAS (4.2 per 1000 live births). Between fiscal years 2010-2011 and 2019-2020 (prepandemic period), NAS increased from 2.6 to 4.8 per 1000 live births. NAS rates were highest in fiscal year 2020-2021 and decreased in 2021-2022 from 5.6 to 4.7 per 1000 live births, respectively. The direction of the temporal trend in NAS rates changed after the onset of the pandemic in June 2020. The relative increase in the NAS rate during the prepandemic period (March 2010-May 2020) was 0.5% per month, whereas the NAS rate decreased by 1.3% per month during the pandemic period (June 2020-March 2022).

Low Birth Weight and Overweight at 20 Raise T2D Risk 10-Fold

MAR 16 2024

Men with low birth weight who go on to be overweight in young adulthood have a nearly 10-fold increased risk of developing type 2 diabetes, reveals Swedish research that indicates the risks can nevertheless be reduced if overweight in young adulthood is avoided. The researchers gathered data on birth weight and height and weight measurements for men from the population-based body mass index (BMI) Epidemiology Study Gothenburg cohort born between 1945 and 1961. School healthcare records were accessed, alongside records for military conscription, which was mandatory for all Swedish men until 2010. The main exposures were birth weight, childhood overweight at 8 years of age, and young adult overweight at 20 years of age, from which age-adjusted BMI estimates were calculated. The individuals were then linked to the Swedish National Patient Register to identify diagnoses of type 2 diabetes after 30 years of age to avoid misclassification with type 1 diabetes. The team included 34,321 men, who were followed up from 30 years of age to December 31, 2019, yielding 1,100,000 person-years of follow-up. Over a median follow-up of 34.3 years, 2733 cases of type 2 diabetes were diagnosed, at a median age of 59.4 years. Birth weight below the median of 3.6 kg and overweight at age 20, but not overweight at age 8, were associated with an increased risk for both early (≤ 59.4 years) and late type 2 diabetes (> 59.4 years). A birth weight below the median plus overweight at age 20 years was associated with a marked increased risk for early diabetes, at a hazard ratio of 6.07, rising to 9.94 among men with low birth weight (≤ 2.5 kg) and overweight at 20 years. The team noted: "Importantly, we observed a 21% absolute risk reduction for early type 2 diabetes if an individual with a low birth weight avoided overweight in young adulthood." "We therefore propose that particular efforts should be directed at children with low birth weight to prevent the subsequent development of young adult overweight and the associated massive risk of type 2 diabetes." Coauthor Jenny M. Kindblom, MD, PhD, from Sahlgrenska University Hospital, Gothenburg, Sweden, suggested in a release: "It's possible that the metabolic consequences of fetal growth restriction…when combined with a detrimental BMI trajectory during puberty, when the insulin resistance is at a lifetime peak due to the surge of growth and sex hormones, result in an additive excess risk for later type 2 diabetes." The research was led by Jimmy Célind, MD, Department of Paediatrics, Institute of Clinical Studies, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

New Product Released

MAR 1 2024

Sylvan Fiberoptics now offers the N103-90 fiberoptic cable, with a 90-degree distal tip, as the lightpipe attachment to the hand-held Neoscan Neo2-W neonatal transilluminators. This provides improved ergonomics while keeping the same four-foot length, functionality, and light output as the straight tipped on- point fiberoptic cables. The design is the direct result of input from nurses and neonatologists. The optical grade glass-silica fibers are bent 90-degree through the stainless-steel distal tip to offer the same on-point transillumination qualities used for decades to help find veins and illuminate chest cavities. Bending the fibers rather than cutting and creating a new connection keeps the light loss at a minimum to maintain the incredibly bright white LED light output being produced. The N103-90 fiberoptic lightpipe is effective, durable, and stays cool. Free trials for the Neoscan Neo2-W with the N103-90 are available. The 90-degree distal tip fiberoptic cables are not currently available for the Pediascan Model 5000 or the Maxiscan Model 1000LEDW transilluminators, however prototypes are being designed. Contact Sylvan Fiberoptics for a quote, literature, or free trial information. email: info@sylvanmed.com; phone: 724-864-9350; website: www.sylvanmed.com.

Prenatal Prescription Opioids Tied to Increased Risk for Preterm Birth

FEB 29 2024

Taking a prescription opioid for pain management during pregnancy is associated with an increased risk for spontaneous preterm birth, data from a new case-control study of over 25,000 Medicaid patients showed. Researchers retrospectively reviewed data on pregnant patients enrolled in Tennessee Medicaid who experienced birth of a single baby at ≥ 24 weeks gestation (25,391 with opioid use disorder and 225,696 without). Median age of participants was 23 years; 58.1% were non-Hispanic White, 38.7% Black, 2.6% Hispanic, and 0.5% Asian. Controls were matched based on pregnancy start date, race, ethnicity, age at delivery (within 2 years), and history of prior preterm birth. Sensitivity analysis included the exclusion of opioid prescriptions dispensed within 3 days of the index date to account for potential opioid prescribing associated with labor pain. A total of 18,702 patients (7.4%) filled an opioid prescription during the 60 days prior to the index date. Each doubling of opioid morphine milligram equivalents (MMEs) prescribed during the 60 days was associated with a 4% increase in the odds of spontaneous preterm birth compared with no opioid exposure in the matched controls (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.08). Overall, 1573 pregnancies filled prescriptions for 900 MMEs or greater, which was associated with at least a 21% increased risk for spontaneous preterm birth compared with no opioid exposure (aOR, 1.21; 95% CI, 1.10-1.33). Researchers found no significant difference in odds of spontaneous preterm birth among included opioid types after adjusting for confounders and opioid MMD. "This association may appear modest, especially considering that common, one-time prescriptions often fall in the 150-225 MME range, but these findings may provide more caution when prescribing multiple, higher strength opioids," the authors wrote. "We also caution against the conclusion that lower doses, especially those below 100 MME, are safe; the confidence bands over the low dose range still include odds ratios that are consistent with meaningful harm." Sarah S. Osmundson, MD, MS, of the Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee, was the senior and corresponding author on the study. The study was published online on February 14 in JAMA Network Open.

AHA: Urgent Need to Reduce Maternal Postpartum CVD Risk

FEB 29 2024

Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and inter-pregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations. The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use. “The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

National Rapid Genome Testing Program Benefits NICU Care

FEB 29 2024

A national study in Israel demonstrates the feasibility and diagnostic benefits of rapid trio genome sequencing in critically ill neonates. Researchers conducted a prospective, multicenter cohort study from October 2021 to December 2022, involving all Israeli medical genetics institutes and neonatal intensive care units. A total of 130 critically ill neonates suspected of having a genetic disorder were enrolled, with rapid genome sequencing results expected within 10 days. Rapid trio genome sequencing diagnosed 50% of the neonates with disease-causing variants, including 12 chromosomal and 52 monogenic conditions. Another 11% had variants of unknown significance that were suspected to be disease-causing, and 1% had a novel gene suspected of causing disease. The mean turnaround time for the rapid reports was 7 days, demonstrating the feasibility of implementing rapid genome sequencing in a national healthcare setting, the researchers said. Genomic testing led to a change in clinical management for 22% of the neonates, which shows the clinical utility of this approach to diagnosis, they said. Genetic testing may identify patients who are candidates for precision medical treatment and inform family planning, which is "critical for families with a severely affected or deceased child," the study authors wrote. The corresponding author for the study was Daphna Marom, MD, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. It was published online on February 22, 2024, in JAMA Network Open.

Exposure to Phthalates Increases Risk for Premature Birth

FEB 29 2024

Phthalates are chemical compounds found in many everyday consumer products, such as plastic food packaging, polyvinyl chloride (PVC) articles, and certain cleaning or cosmetic products. They are considered endocrine and metabolic disruptors, and their use is regulated in toys, electronic devices, food packaging, medical devices, and cosmetics. Some phthalates are classified as toxic to reproduction. Prenatal exposure could disrupt the development of certain tissues or organs, thus promoting potential health consequences in adulthood that could persist over several generations through epigenetic mechanisms. Numerous studies have also suggested that phthalates influence the course of pregnancy and may lead to premature birth. However, the proportion of the risk for premature birth attributable to these chemical compounds has not yet been quantified. That is why a prospective study was conducted in the United States, involving > 5000 women in whom phthalate metabolites were found in urine samples. The concentrations of phthalate metabolites are roughly the same, regardless of the stage of pregnancy. The data confirm the link between phthalate concentration in urine and the risk of premature birth. Bis(2-ethylhexyl) phthalate (DEHP) was the most widely used phthalate in PVC objects before it was regulated. DEHP is associated with a 45% increase in the risk for premature birth. The most significant increase in risk is associated with urine levels of phthalic acid, diisodecyl phthalate, di-n-octyl phthalate, and diisononyl phthalate. These compounds replaced DEHP after the establishment of regulations limiting the use of the latter. The contribution of phthalates to the occurrence of premature births is far from negligible. Nearly 57,000 preventable premature births occur each year in the United States, with an associated cost of $3.84 billion. Safer alternatives exist, but the barrier to their use seems to be cost. Therefore, the authors attempted to estimate the environmental burden and health cost of phthalate use, including not only the short- and medium-term consequences of premature births but also child obesity and chronic diseases related to phthalates, such as adult obesity and diabetes, endometriosis, male infertility, and cardiovascular mortality. They estimated that for the United States, this total cost amounts to approximately $100 billion annually, in addition to the cost of the environmental impact of plastic in the United States, which was recently estimated at $250 billion each year. The authors encouraged individual initiatives to reduce exposure to phthalates. They particularly recommended choosing cosmetics labeled as phthalate-free and replacing plastic-wrapped foods with fresh products.

Dräger receives Frost & Sullivan’s 2024 Best Practices Company of the Year Award

FEB 27 2024

Dräger, an international leader in medical and safety technologies, announced that Frost & Sullivan has selected the company for its 2024 Best Practices Company of the Year Award in the global respiratory care devices industry. Frost & Sullivan’s selection process involves identifying companies that consistently develop growth strategies based on a visionary understanding of the future and effectively address new challenges and opportunities employing best practices and strategic analytics across a value chain. “Today’s healthcare decision makers are looking beyond devices to determine the value a product brings to their critical care environments,” said President and CEO for Draeger, Inc., Lothar Thielen. “This award validates Dräger’s approach of combining best-in-class products, cost-effective accessories, and service solutions – which together deliver unmatched value to the hospitals we support.” Addressing hospital needs by offering easy-to-use and cost-conscious solutions According to Utkarsha Soundankar, senior research analyst at Frost & Sullivan, “Dräger has become one of the leading respiratory device vendors for its enhanced clinical outcomes, product quality, longterm customer support, and ongoing education tools, all of which assist in offering patient safety and enhanced care.” Dräger developed its new Evita V600, V800 and Babylog VN800 ventilators based on customer requirements for improving patient safety, patient outcomes, and hospital workflow. These devices can provide various modes of ventilation – such as high-flow O2 therapy, non-invasive ventilation, and invasive ventilation modes – using the same accessories. This eliminates the need to use multiple devices for critically ill patients who require different types of respiratory support, thereby streamlining workflow and reducing equipment costs. Providing visionary scenarios through mega trends Frost & Sullivan salutes Dräger for introducing first-to-market solutions and continually investing in the development of new technologies. One such example is Dräger’s research collaboration with STIMIT for the investigation of ventilator-induced diaphragmatic dystrophy (VIDD). STIMIT is developing noninvasive diaphragm stimulation for preserving diaphragm thickness. An FDA-approved clinical trial for this emerging technology began in January 2024. Fostering excellent customer ownership and service experiences Used by leading hospitals worldwide, Dräger’s respiratory devices are clinically validated, with detailed consideration for the hospital’s specific application. To support hospital infection control protocols, Dräger designs its devices with smooth services and minimal nooks that can harbor infectious agents. The company has also developed an extensive line of single-patient use and reusable valves. Frost & Sullivan cites Dräger’s best-in-class services, a network of over 3000 technicians, remote service, 24/7 hotline support, and exceptional service follow up. The company also offers webinars and training classes for healthcare facilities that want to manage their own programs. Dräger has a strong leadership team and actively supports the respiratory care community. As of 2023, Dräger donated more than 150 ventilators to respiratory schools in the United States to train the next generation of therapists and will donate another 185 ventilators in 2024.

Newborn Recipient of Partial Heart Transplant Doing Well

JAN 30 2024

A first-of-its-kind partial heart transplant in a neonate delivered valves that continue to grow and function beyond 1 year of age, researchers said. The surgery was performed on the 18th day of life of a 5-pound newborn boy diagnosed prenatally with persistent truncus arteriosus and severe truncal valve dysfunction. The procedure involved transplantation of the part of the heart containing the aorta and pulmonary valves from an infant donor upon cardiac death. The standard of care for neonatal heart valve implants are cadaver grafts. But these grafts are not viable and can’t grow or self-repair. Therefore, recipient neonates need to undergo repeated implant-exchange surgeries until an adult-sized heart valve can fit. Clinical outcomes generally are poor. The donor was a 2-day-old female weighing 8 pounds. Delivery had been complicated by hypoxic ischemic brain injury, but echocardiography showed structurally normal, functioning outflow heart valves. The heart was donated after cardiac death and procured using standard surgical techniques. The recipient infant’s operation involved sternotomy, cardiopulmonary bypass, and cardioplegic arrest of the heart. The pulmonary artery ostia and coronary artery buttons were dissected, and the infant’s irreparable truncal valve was excised. The donor aortic root was transplanted first, using donor tissue to close the ventricular septal defect. Then, the coronary artery buttons were reimplanted; the right ventricular outflow tract was enlarged; and the pulmonary root was transplanted. Postoperative immunosuppression followed. On the follow-up at age 14 months, the transplanted valves showed no obstruction or insufficiency on echocardiography.

500-mg Calcium Pill Protects Against Preeclampsia, Researchers Say

JAN 30 2024

Taking 500 mg of calcium a day reduces the likelihood of developing preeclampsia in pregnant women as much as higher doses, according to a study in The New England Journal of Medicine. The study also shows that the lower dose of calcium protects against preterm birth almost as well as the higher dose recommended by the World Health Organization (WHO).  Preeclampsia complicates up to 8% of pregnancies and may contribute to 45,000 maternal deaths globally every year. The US Centers for Disease Control and Prevention estimates that preeclampsia occurs in about 1 in 25 pregnancies, and Black women are 60% more likely to develop the condition than are White women. Calcium supplementation reduces the risks for preeclampsia, per WHO guidelines. The WHO has recommended between 1500 mg and 2000 mg of calcium supplementation daily along with one 30- to 60-mg iron pill for pregnant women who receive insufficient calcium in their diets, which the WHO says generally occurs in lower-income nations and not wealthier nations, such as the United States. This dosage amounts to a minimum of three calcium pills per day because the dietary supplements generally come from suppliers in 500-mg doses. Researchers say the supplements are too expensive for many health authorities of low- and middle-income nations to provide, and that taking so many pills presents a barrier to use even if they were plentiful. In countries such as Tanzania and India, study author Christopher Sudfeld, ScD, associate professor of global health and nutrition at Harvard University's T.H. Chan School of Public Health, in Boston, Massachusetts, explained, governments generally distribute supplements like calcium for free at health clinics. Due to the cost, Tanzania has never implemented WHO's calcium recommendation, Sudfeld said, providing only the iron pill. The randomized double-blinded study included 11,000 pregnant women in Tanzania and 11,000 pregnant women in India. None had yet given birth, which increased their risk for preeclampsia. All participants were older than 18 years and were less than 20 weeks pregnant, according to their most recent menstrual date. Half of participants received the three daily 500-mg calcium pills recommended by WHO; the other half received a single calcium pill and two placebo pills. Researchers measured blood pressure and urine protein levels starting at 20 weeks of gestation, at delivery, and 6 weeks after giving birth. Regardless of how much calcium people consumed daily, preeclampsia occurred approximately 3% of both the 500-mg and 1500-mg groups. Similar rates of preterm births occurred in both groups, although in Tanzanian, women in the 500-mg arm were somewhat more likely to give birth early.

Notice Issued for Ventilators

JAN 19 2024

Valued Customers, Bunnell Incorporated hereby announces the Model 203 LifePulse High Frequency Jet Ventilator will be rendered obsolete as of July 1, 2026. The aging ventilators have been used in the critical care of neonates for 36 years. Bunnell intends to service and support these neonatal ventilators until the date of obsolescence. Hospitals are encouraged to migrate to the newer Model 204 LifePulse High Frequency Jet Ventilator, which has been on the market since 2017. The Model 204 LifePulse HFJV provides the same therapy and utilizes the same disposables. Model 203 ventilators may be traded in towards the purchase of the Model 204 LifePulse HFJV. To learn more about the enhanced features of the new LifePulse High Frequency Jet Ventilator Model 204, visit www.bunl.com. For inquiries call 800-800-4358 or email info@bunl.com.

Pandemic Drove Premature Births Up, Vaccinations Brought Numbers Down: Study

JAN 2 2024

The number of premature births in California jumped during the first year of the COVID-19 pandemic and came back down after vaccinations became widely available, new evidence reveals.

For example, researchers found that during that year, there was a 29% increase in deliveries before 37 weeks of gestation. In absolute percentages, rates increased from 7.3% to 8.7%. When they accounted for maternal social, demographic, and other factors, there remained a 15% increase in the likelihood of preterm births, from 7.3% to 8.4%. This increased rate that was associated with the pandemic in 2020 disappeared completely by 2022. But not all areas of the state returned to baseline quickly. "One finding that was surprising is the sharp decline in the impact of maternal COVID-19 infection on preterm birth in areas with high vaccination rates compared to areas with low vaccination rates," said lead investigator Florencia Torche, PhD, professor of sociology at Stanford University in California. "This sharp decline supports the claim that it was vaccination ― rather than alternative health-protecting behaviors among pregnant people — that accounts for the reduction in preterm risk," Torche said. Rates of premature births did not differ significantly until May 2021, the point that vaccines became more widely available. However, in comparing babies born to women who tested positive at birth from July 2020 to February 2023 to siblings not exposed to COVID, they found "marked differences." COVID vaccination helped avoid thousands of preterm births and related complications, the authors note. It was also cost saving. Research shows that each preterm birth was estimated to cost more than $80,000, they added. "A critical implication of this study is that vaccination provides an effective protective mechanism for the health of the newborn, substantially reducing the risk of preterm and other adverse infant health outcomes," Torche said. The observations are "not necessarily surprising, given that some studies had proposed that COVID was associated with preterm birth, while others, carried out in the late period when the majority of women were vaccinated, no longer found this association," said Emmanuel Bujold, MD, full professor of maternal and fetal medicine in the Faculty of Medicine, Laval University, Quebec, Canada, who was not affiliated with the study. "But these were only indirect scientific evidence, whereas the study proposed today represents direct evidence of the benefit of vaccination." Bujold said this scientific approach confirms the hypotheses from some smaller studies and helps to reassure pregnant women about vaccination. "Personally, I feel that these data, combined with previous studies on the safety of vaccination, are sufficient to recommend vaccination against COVID-19 to pregnant women." Torche cautioned that even though the news from this study is positive, there is no guarantee that preterm birth rates related to the pandemic will remain at baseline. "The consequences of COVID-19 infection might increase in the future as viral variants change and immunity conferred by vaccination or prior infection wanes." Moving forward, Torche and her colleague Jenna Nobles, PhD, hope to drill down deeper into the data beyond preterm rates based on ZIP code to evaluate the effects of COVID vaccination for individual pregnant women.

Saving Preterm Babies: Research Shows Deferred Umbilical Cord Clamping Works

JAN 2 2024

For preterm babies, delaying umbilical cord clamping after birth reduces the risk of mortality by around 30% in comparison with immediate cord clamping, according to a new meta-analyses published in The Lancet.Researchers also assessed the efficacy of cord milking, the practice of pumping blood to the baby through the cord, and found no statistically significant improvement in the rate of deaths before discharge compared to immediate or deferred cord clamping. While a large body of research shows that deferred cord clamping and cord milking improve infant survival rates, until now, researchers had not reached a clear consensus on which strategies work best, according to Anna Lene Seidler, PhD, senior research fellow at the Clinical Trials Center of the National Health and Medical Research Council at the University of Sydney in Australia. "We brought together this really large database to be able to ask the question, 'What actually works best? How can we improve survival for preterm infants?' " Seidler, the lead author of both studies, said. Previous studies have shown that waiting to clamp the umbilical cord improves circulation, increases iron storage, and lowers rates of brain bleeding. "But to show a decrease in overall mortality is impressive," said Ilina Pluym, MD, assistant clinical professor of obstetrics and gynecology at the David Geffen School of Medicine at University of California, Los Angeles. Although "before practice change can be recommended widely, I would want to see the results repeated among a broader general population." In 2022, 1 in 10 babies in the United States were born preterm. The rate of infant mortality due to prematurity or low birthweight was 87.1 per 100,000 live births in 2020.

AHA, AAP Update Neonatal Resuscitation Guidelines

JAN 2 2024

The American Heart Association (AHA) and American Academy of Pediatrics (AAP) have issued a focused update to the 2020 neonatal resuscitation guidelines. The 2023 focused update was prompted by four systematic literature reviews by the International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force. The groups noted that effective positive-pressure ventilation (PPV) is the priority in newborn infants who need support after birth. And while the 2020 update provided some details on devices to be used for PPV, the 2023 focused update gives guidance on use of T-piece resuscitators for providing PPV, which may be particularly helpful for preterm infants, and the use of supraglottic airways as a primary interface to deliver PPV, he explained. Specifically, the updated guidelines state that use of a T-piece resuscitator to deliver PPV is preferred to the use of a self-inflating bag. Because both T-piece resuscitators and flow-inflating bags require a compressed gas source to function, a self-inflating bag should be available as a backup in the event of compressed gas failure when using either of these devices. Use of a supraglottic airway may be considered as the primary interface to administer PPV instead of a face mask for newborn infants delivered at 34 0/7 weeks' gestation or later. The updated guidelines continue to emphasize delayed cord clamping for both term and preterm newborn infants when clinically possible. There is also a new recommendation for nonvigorous infants born 35-42 weeks' gestational age to consider umbilical cord milking. Specifically, the guidelines state: For term and late preterm newborn infants ≥34 weeks' gestation, and preterm newborn infants <34 weeks' gestation, who do not require resuscitation, delayed cord clamping (≥30 seconds) can be beneficial compared with early cord clamping (<30 seconds). For term and late preterm newborn infants ≥34 weeks' gestation who do not require resuscitation, intact cord milking is not known to be beneficial compared with delayed cord clamping (≥30 seconds). For preterm newborn infants between 28- and 34-weeks' gestation who do not require resuscitation and in whom delayed cord clamping cannot be performed, intact cord milking may be reasonable. For preterm newborn infants <28 weeks' gestation, intact cord milking is not recommended. For nonvigorous term and late preterm infants (35-42 weeks' gestation), intact cord milking may be reasonable compared with early cord clamping (<30 seconds). The guidelines also highlight the following knowledge gaps that require further research: Optimal management of the umbilical cord in term, late preterm, and preterm infants who require resuscitation at delivery. Longer-term outcome data, such as anemia during infancy and neurodevelopmental outcomes, for all umbilical cord management strategies. Cost-effectiveness of a T-piece resuscitator compared with a self-inflating bag. The effect of a self-inflating bag with a positive end-expiratory pressure valve on outcomes in preterm newborn infants. Comparison of either a T-piece resuscitator or a self-inflating bag with a flow-inflating bag for administering PPV. Comparison of clinical outcomes by gestational age for any PPV device. Comparison of supraglottic airway devices and face masks as the primary interface for PPV in high-resourced settings. The amount and type of training required for successful supraglottic airway insertion and the potential for skill decay. The utility of supraglottic airway devices for suctioning secretions from the airway. The efficacy of a supraglottic airway during advanced neonatal resuscitation requiring chest compressions or the delivery of intratracheal medications.

Masimo Receives FDA Clearance for Baby Monitoring System

DEC 18 2023

Masimo, a global leader in innovative monitoring technologies used in top hospitals, announced today FDA clearance of Stork, a revolutionary baby monitoring system, for prescription use with healthy and sick babies 0-18 months of age. Leveraging the same Masimo sensor technology that monitors more than 10 million babies in hospitals every year, Stork provides continuous, accurate monitoring of a baby’s health. Stork is available at retailers nationwide as a non-medical device for general health and wellness purposes. With this clearance, Stork is now available for prescription use to continuously monitor babies at home as a medical device for healthy or sick babies. "When my son was born, we were concerned about his breathing. Our doctor prescribed pulse oximetry monitoring for a week for him. A therapist arrived at our home with a large standalone pulse oximeter made for hospitals, with cables and wires everywhere and tethered to our son, and charged us $5,000 for a week of monitoring," said Joe Kiani, Founder and CEO of Masimo. "I know how important it is for parents to better understand their baby’s physiological well-being, especially when they are sick, and it’s our privilege to provide them with an easy-to-use, accurate product that allows them to continuously monitor key vital signs for less than one tenth of the cost I paid, and also includes video surveillance." When prescribed, parents and family members will now be able to receive alarms regarding their baby’s oxygen saturation (SpO2), pulse rate (PR), and skin temperature. They will be able to share these vital signs data remotely with clinicians. In addition, Stork alerts parents if their baby turns over and is sleeping face down, which can be dangerous for babies. Stork leverages the same technology that has been used on babies in the neonatal intensive care unit (NICU) for years, helping to improve health outcomes for the youngest and most vulnerable patients. Known as Signal Extraction Technology, or SET, this technology has helped clinicians reduce the incidence of neonatal blindness from retinopathy of prematurity1 and has led to significant improvements in screening newborns for critical congenital heart disease. Stork’s SpO2 performance specification is industry-leading, at 1.5% ARMS* at one standard deviation, even during motion. This patented sensor technology nests within the Stork boot, which is made from an ultra-soft, medical-grade silicone that conforms gently to the baby’s skin and is available in three sizes to ensure a perfect fit as the child grows. The sensor embedded in the boot is the product of meticulous engineering that harnesses decades of expertise in non-invasive monitoring to detect babies’ SpO2, PR, and skin temperature continuously with unprecedented accuracy and dependability. With a sleek, minimalistic design ideal for any nursery aesthetic, the Stork Vitals+ bundle includes the boot with sensor that monitors baby’s skin temperature, pulse rate, and oxygen saturation, and a 2K Quad High-Definition (QHD) capable camera with technology supported by the TODA platform from Like Minded Labs. The camera hardware and software architecture are designed to leverage and be compatible with future edge AI-based features, in development. For those who do not require streaming video, the Stork Vitals bundle replaces the camera with a health hub, which connects the Stork vital signs sensor/boot to the Stork app, while still allowing parents to hear and speak to their baby. Stork also monitors the temperature of the baby’s room. Dr Ryan S. Bode, a national leader in pediatric hospital medicine and pediatric quality and safety, commented, "I have cared for hospitalized children for over 20 years. In addition, my passion and research interests have focused on quality improvement and patient safety in delivering high value pediatric care and ensuring optimal patient outcomes. Masimo SET® pulse oximetry technology is unmatched in its ability to measure accurately even when children move or have low perfusion. Any caregiver, parent, or clinician looking to monitor key vitals in young babies should ensure they have accurate, reliable technology, like SET® pulse oximetry." Dr Mitchell R. Goldstein, Professor of Pediatrics at Loma Linda University, said, "I had the privilege of having access to one of the earliest Masimo SET pulse oximeters. A young baby, Joshua, came to our unit at extremis, and we attempted all life-saving measures to get his pulse on a non-Masimo device. With no success, we then tried the Masimo monitor and were able to get readings of his vitals, a signal that we should continue to provide care. Joshua survived and was eventually sent home with his parents, and our unit has relied on Masimo SET ever since. It is the only pulse oximeter I’m aware of that has provided the ability from the beginning to measure through challenging conditions and with darker skin colors, as was the case with Joshua. I am glad to see this life-saving technology being expanded to the home." For non-medical use, Masimo Stork bundles are available for direct consumer purchase at MasimoStork.com and on shelves at major and specialty U.S. retailers. To access Masimo Stork’s FDA-cleared features, parents can discuss Stork with their child’s primary care physician or, in a soon-to-be-released update, online with a physician via the Masimo Stork App. For prescription use, Masimo Stork is 510(k) cleared for the following intended use: Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments. Masimo Stork is indicated for the spot-checking and continuous monitoring of SpO2 and PR in infants and neonates during no motion, motion, and low perfusion conditions. Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.

AHA, AAP Update Neonatal Resuscitation Guidelines

DEC 1 2023

The American Heart Association (AHA) and American Academy of Pediatrics (AAP) have issued a focused update to the 2020 neonatal resuscitation guidelines. The 2023 focused update was prompted by four systematic literature reviews by the International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force. "Evidence evaluations by the ILCOR play a large role in the group's process and timing of updates," Henry Lee, MD, co-chair of the writing group, said. He noted that updated recommendations do not change prior recommendations from the 2020 guidelines. "However, they provide additional details to consider in neonatal resuscitation that could lead to changes in some practice in various settings," said Lee, medical director of the University of California San Diego neonatal intensive care unit. Lee noted that effective positive-pressure ventilation (PPV) is the priority in newborn infants who need support after birth. And while the 2020 update provided some details on devices to be used for PPV, the 2023 focused update gives guidance on use of T-piece resuscitators for providing PPV, which may be particularly helpful for preterm infants, and the use of supraglottic airways as a primary interface to deliver PPV, he explained. Specifically, the updated guidelines state that use of a T-piece resuscitator to deliver PPV is preferred to the use of a self-inflating bag. Because both T-piece resuscitators and flow-inflating bags require a compressed gas source to function, a self-inflating bag should be available as a backup in the event of compressed gas failure when using either of these devices. Use of a supraglottic airway may be considered as the primary interface to administer PPV instead of a face mask for newborn infants delivered at 34 0/7 weeks' gestation or later.

Saving Preterm Babies

DEC 1 2023

For preterm babies, delaying umbilical cord clamping after birth reduces the risk of mortality by around 30% in comparison with immediate cord clamping, according to a new meta-analyses published in The Lancet.Researchers also assessed the efficacy of cord milking, the practice of pumping blood to the baby through the cord, and found no statistically significant improvement in the rate of deaths before discharge compared to immediate or deferred cord clamping. While a large body of research shows that deferred cord clamping and cord milking improve infant survival rates, until now, researchers had not reached a clear consensus on which strategies work best, according to Anna Lene Seidler, PhD, senior research fellow at the Clinical Trials Center of the National Health and Medical Research Council at the University of Sydney in Australia. "We brought together this really large database to be able to ask the question, 'What actually works best? How can we improve survival for preterm infants?' " Seidler, the lead author of both studies, said. Previous studies have shown that waiting to clamp the umbilical cord improves circulation, increases iron storage, and lowers rates of brain bleeding. "But to show a decrease in overall mortality is impressive," said Ilina Pluym, MD, assistant clinical professor of obstetrics and gynecology at the David Geffen School of Medicine at University of California, Los Angeles. Although "before practice change can be recommended widely, I would want to see the results repeated among a broader general population." In 2022, 1 in 10 babies in the United States were born preterm. The rate of infant mortality due to prematurity or low birthweight was 87.1 per 100,000 live births in 2020.

Are We Ready for Systematic Newborn Genome Sequencing?

DEC 1 2023

Will the traditional newborn screening program developed 60 years ago by Dr Robert Guthrie soon be superseded by genome screening at birth? Routine sampling and analysis of newborn DNA would allow us to screen for many hundreds of childhood genetic diseases. This is the claim made by David Geneviève, MD, PhD, chair of the French Association of Clinical Geneticists and lecturer at the University of Montpellier, France, at the 9th annual conference of the French Society of Predictive and Personalized Medicine (SFMPP). To date, newborn screening has consisted of taking a drop of blood from a newborn's heel. In the future, DNA samples could be taken from babies for whole genome sequencing to look for diseases that are likely to crop up later in life. "In France, nearly all of the 720,000 babies born each year undergo newborn screening (only 300 refuse)," said Geneviève. For 60 years, newborn screening has tested for phenylketonuria, congenital hypothyroidism, congenital adrenal hyperplasia, sickle cell disease, cystic fibrosis and medium-chain acyl-coenzyme A dehydrogenase (MCAD) deficiency. On January 1, 2023, France's national newborn screening program added seven new diseases, bringing the number of rare diseases screened for to 13. The new diseases are homocystinuria, maple syrup urine disease, tyrosinemia type 1, isovaleric acidemia, glutaric aciduria type I, long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency, and carnitine deficiency. "There aren't just 13 childhood diseases," continued Geneviève. "There are several hundred rare diseases, and genome sequencing tools allow us to broaden our screening capabilities. It's inevitable that the ability to sequence your child's genome at birth will become a possibility. It's highly likely that within 10 to 15 years, all newborns will have their genome determined at birth for screening purposes." Genome sequencing has already been studied for several years in multiple countries. New York's Guardian study requires all newborns taking part to undergo genome sequencing. "Our English-speaking colleagues use the genome to screen for childhood diseases that would benefit from treatment (235 can be treated) but also as a preventive measure and a way of providing early therapeutic education," said Geneviève. In 2016, American researchers launched the BabySeq Project, which was conducted at several sites (Boston, New York, Birmingham, Detroit, and Philadelphia). One of its aims is to assess the medical, psychological, and financial impact of screening via genome sequencing at birth, compared with conventional screening.

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

NOV 17 2023

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

Pregnancy in Rheumatic Disease Quadruples Risk of Cardiovascular Events

NOV 16 2023

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

A Dozen Genes Found Dangerous in Pregnancy

OCT 30 2023

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

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

OCT 30 2023

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

COVID Shot While Pregnant Limits Severe Cases in Infants Says CDC

OCT 30 2023

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

'No Measurable Change' in Global Preterm Birth Rates

OCT 30 2023

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

 

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

Ultrasonic Irradiation and Fetal Damage: Researcher Explores Possible Link

OCT 30 2023

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

Death Rate Rises in Babies

OCT 30 2023

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

Company Signs Contract for Device

OCT 16 2023

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

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

COVID Shot While Pregnant Limits Severe Cases in Infants Says CDC

OCT 13 2023

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

PyrAmes Receives FDA Clearance for Boppli Wearable Blood Pressure Monitoring Device

OCT 4 2023

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

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

OCT 2 2023

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

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

SEP 15 2023

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

Is Society Ready for an Artificial Womb?

SEP 13 2023

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

Study Links Preterm Births to Mother's Poor Mental Health

AUG 30 2023

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

No Reduction in Cerebral Palsy With Later Prenatal Magnesium

AUG 30 2023

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

Healthy Babies Can Still Get Very Sick From RSV

AUG 30 2023

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

Preterm Birth Rates Higher in Black Patients

AUG 30 2023

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

Etiometry Gains FDA Clearance of AI-Based Algorithm

AUG 9 2023

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

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

Neotech Launches Tubing Holder

AUG 2 2023

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

New AAP Framework Seeks to Help Pediatricians Monitor Premature Babies

JULY 3 2023

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

OCD Linked to Adverse Pregnancy and Neonatal Outcomes

JULY 3 2023

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

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

JUNE 27 2023

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

FDA Panel Backs Sanofi-AstraZeneca's Preventive RSV Therapy

JUNE 15 2023

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

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

JUNE 15 2023

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

Tankless Delivery System Recognized as a ‘Technological Breakthrough’

JUNE 13 2023

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

Study Shows Prolacta’s Fortifiers Significantly Increase Bioactivity

JUNE 12 2023

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

Dietary Fiber Cut Gestational Diabetes, Preterm Birth

MAY 29 2023

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

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

MAY 29 2023

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

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

MAY 29 2023

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

New Device Launched to Monitor Oxygen Concentration

April 26 2023

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

Noisy Incubators Could Stunt Infant Hearing

April 14 2023

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

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

April 14 2023

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

Can Asthma Be Prevented in Children Before Birth?

March 30 2023

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

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

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

Neonatal Bilirubin Meters Need Better Accuracy

March 30 2023

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

Beyond Air Appoints New Chief Medical Officer

March 23 2023

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

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

March 21 2023

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

Neonatal Bilirubin Meters Need Better Accuracy

March 16 2023

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

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

March 16 2023

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

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

March 15 2023

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

Babies' Movement in the Womb Means Something

March 1 2023

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

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

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

Maternal COVID-19 Vaccine Curbs Infant Infection From Delta Variant

March 1 2023

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

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

February 27 2023

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

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

FEBRUARY 15 2023

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

Maternal COVID-19 Vaccine Curbs Infant Infection from Delta Variant

FEBRUARY 15 2023

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

Hope for Catching Infants With CP Early

FEBRUARY 1 2023

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

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

State Quality Initiative Can Reduce Postpartum Hemorrhage and Maternal Morbidity

January 16 2023

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

Infantile Hemangioma: Analysis Underscores Importance of Early Propranolol Treatment

January 16 2023

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

EU Commission Approves Delay in Medical Devices Law to Avert Shortages

January 16 2023

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

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

January 9 2023

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

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

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

These include:

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

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

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

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

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

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

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

Important Safety Information

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

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

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

JANUARY 3 2023

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