Pediatrix Medical Group Publishes New Research on Probiotic Use and Necrotizing Enterocolitis in Preterm Infants
Pediatrix Medical Group, a leading provider of physician services focused on maternal, fetal, pediatric, and neonatal care, has announced the publication of important new research examining the relationship between probiotic use and necrotizing enterocolitis (NEC) in extremely preterm infants. The study addresses one of the most widely debated topics in modern neonatology and provides valuable insights into the potential impact of changes in probiotic practices within neonatal intensive care units (NICUs).
The research was conducted by clinicians affiliated with the Pediatrix Center for Research, Education, Quality and Safety in collaboration with the NEC Society, a nonprofit organization dedicated to preventing and understanding NEC. Investigators utilized data from the Pediatrix Clinical Data Warehouse (CDW), one of the largest and most comprehensive neonatal databases in the world. The CDW contains extensive clinical information and outcomes data collected from neonatal care settings across the United States and has contributed to more than 250 peer-reviewed scientific publications.
The findings were published in the Journal of Perinatology and represent one of the largest studies to evaluate the effects of changing probiotic use practices among extremely premature infants. Researchers analyzed data from more than 10,000 infants born at extremely low gestational ages, providing a large and statistically meaningful patient population for evaluating outcomes associated with NEC.
Necrotizing enterocolitis is a serious gastrointestinal disease that primarily affects premature infants. The condition causes inflammation and damage to the intestinal tissue and can rapidly progress to life-threatening complications. Despite advances in neonatal medicine, NEC remains one of the leading causes of illness and mortality among very low birth weight and extremely preterm infants. Healthcare providers have long searched for effective strategies to reduce the risk of this devastating condition.
For many years, probiotics have been used in some NICUs as a preventive measure against NEC. Probiotics are live microorganisms that may help support healthy gut bacteria and improve intestinal health. Numerous studies have suggested that probiotic supplementation may reduce the incidence of NEC in premature infants. However, concerns regarding product quality, safety, and regulatory oversight have contributed to ongoing debate regarding their routine use.
In 2023, the U.S. Food and Drug Administration (FDA) issued warning actions related to certain probiotic products used in neonatal care settings. Following these actions and the subsequent withdrawal of commonly used probiotic products from the market, many hospitals significantly reduced or discontinued probiotic administration in their NICUs.
The newly published Pediatrix study sought to evaluate whether these changes in clinical practice were associated with differences in NEC rates among extremely preterm infants. Researchers found that hospitals that sharply reduced probiotic use after the FDA actions experienced an increase in NEC rates among their most vulnerable neonatal patients.
Because NEC is relatively uncommon compared with other neonatal complications, large datasets are essential for conducting meaningful retrospective analyses. The size and breadth of the Pediatrix Clinical Data Warehouse allowed researchers to examine outcomes across a substantial population and identify trends that may not have been visible in smaller studies. According to investigators, the CDW may be uniquely positioned to answer important neonatal research questions quickly and effectively because of its extensive clinical reach.
The study’s findings suggest that the rapid discontinuation of probiotics may have had unintended consequences for extremely preterm infants who are at the highest risk of developing NEC. However, researchers emphasized that the study was observational in nature and should not be interpreted as definitive proof of a direct cause-and-effect relationship.
Importantly, the analysis did not identify which specific probiotic strains, products, formulations, or dosage regimens may be the safest or most effective. The authors noted that additional prospective clinical trials are necessary to establish clear recommendations regarding probiotic use in neonatal populations. They also highlighted the need for improved regulatory pathways to ensure the availability of safe, high-quality products specifically developed for premature infants.
Dr. Veeral Tolia, lead author of the study and Director of Clinical Data Warehouse Research, stated that the findings contribute meaningful real-world evidence to an ongoing discussion within the neonatal care community.
According to Dr. Tolia, while prospective studies remain necessary to better understand optimal treatment strategies, the current analysis indicates that abrupt changes in clinical practice may have significant consequences for infants at the highest risk of NEC. He emphasized that evidence generated from large-scale clinical databases can help healthcare providers make informed decisions while awaiting further research.
The study also represents an important milestone in collaborative neonatal research. The NEC Society played a key role in the project, marking the first time a nonprofit organization dedicated to patient and family engagement has participated in a study utilizing the Pediatrix Clinical Data Warehouse. This partnership reflects a growing commitment within healthcare research to include patient advocates and families in the scientific process.
Jennifer Canvasser, founder of the NEC Society and one of the study’s authors, highlighted the importance of bringing together clinicians, researchers, regulators, and families to address the ongoing challenges associated with NEC. She emphasized that collaborative efforts are essential for identifying gaps in scientific knowledge and developing strategies that can better protect vulnerable infants.
Canvasser noted that NEC continues to have a profound impact on families worldwide, making continued investment in research and innovation critical. Through partnerships such as this one, researchers can generate evidence that informs clinical care and supports improved outcomes for newborns and their families.
The publication contributes to a growing body of literature exploring the potential role of probiotics in preventing NEC. While questions remain regarding product selection, safety standards, and regulatory oversight, the findings add further support to the hypothesis that probiotics may offer protective benefits for certain populations of preterm infants.
At the same time, the authors caution that additional research is needed before definitive clinical recommendations can be established. Future studies will likely focus on identifying the most effective probiotic strains, determining appropriate dosing strategies, evaluating long-term safety outcomes, and developing products specifically designed for neonatal use.
The study underscores the importance of robust clinical databases in advancing neonatal medicine. By leveraging large-scale, real-world data resources such as the Pediatrix Clinical Data Warehouse, researchers can rapidly investigate critical healthcare questions and generate evidence that informs patient care.
Additional authors of the study include Monica M. Bennett, Ph.D., Darren Handler, Rachel G. Greenberg, M.D., Robert Ursprung, M.D., Kaashif A. Ahmad, M.D., and Ravi Patel, M.D., MSc. Together, the research team contributed expertise across neonatology, clinical research, data analysis, and patient advocacy.
As discussions regarding probiotic use in NICUs continue, this research provides an important contribution to the evidence base and highlights the need for continued collaboration among healthcare providers, researchers, regulators, and patient advocacy organizations. Ultimately, the goal remains the same: improving outcomes and reducing the burden of NEC among the most vulnerable newborn patients.
About Pediatrix Medical Group
Pediatrix® Medical Group, Inc. (NYSE:MD) is a leading provider of physician services. Pediatrix-affiliated clinicians are committed to providing coordinated, compassionate and clinically excellent services to women, babies and children across the continuum of care, both in hospital settings and office-based practices. Specialties include obstetrics, maternal-fetal medicine and neonatology complemented by multiple pediatric subspecialties. The group’s high-quality, evidence-based care is bolstered by significant investments in research, education, quality-improvement and safety initiatives. The physician-led company was founded in 1979 as a single neonatology practice and today provides its highly specialized and often critical care services through approximately 4,300 affiliated physicians and other clinicians.
The NEC Society is the world’s leading nonprofit dedicated to necrotizing enterocolitis (NEC). The NEC Society brings together patient families, clinicians and scientists to advance NEC research, education and advocacy for a world without NEC.
