From Probiotics to Biotherapeutics in the NICU
Miami Neonatology 2025—49th Annual International Conference

This education is about:

• The neonatal microbiome and dysbiosis in preterm infants
• Clinical evidence for the use of probiotics in NEC prevention
• Strain-specific differences in probiotics for preterm infants
• Comparison of probiotics and biotherapeutics
• Clinical trial data on novel biotherapeutics for NEC prevention

Why it matters:
Probiotics are widely studied for NEC prevention, but variability in strain selection and product quality and safety, complicates clinical decision-making. This activity clarifies the evidence, safety considerations, and regulatory differences between dietary probiotic supplements and biotherapeutics, helping neonatal clinicians make informed decisions as microbiome-based therapies evolve.

What you will learn:This activity traces the evolution of microbiome-based interventions in the NICU, from traditional probiotic supplementation to regulated live biotherapeutic products. Dr. del Moral reviews mechanisms of dysbiosis in preterm infants, evidence for NEC prevention, and limitations of current probiotic formulations. The session highlights safety data, regulatory frameworks, and recent trial data evaluating pharmaceutical-grade biotherapeutics. By contrasting probiotic supplements with biotherapeutics, the activity contextualizes current gaps in knowledge and future directions for safely restoring microbiome balance in vulnerable neonatal populations.

Faculty

• Profile

  Teresa del Moral, MD, MPH, PhD

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  Teresa del Moral, MD, MPH, PhD, is a professor of clinical pediatrics at the University of Miami/Jackson Memorial Hospital in Miami, Florida. She received her MD and PhD degrees from the University of Granada in Spain and completed residencies in pediatrics at University Hospital San Cecilio, Granada, and Jackson Memorial Hospital, Miami. Dr. del Moral was awarded fellowships in neonatology by the University of Miami, where she also earned her MPH degree. She is board certified in pediatrics and in neonatal-perinatal medicine.

  Jackson Memorial Hospital is home to one of the largest neonatal intensive care units in the nation, known worldwide for its cutting-edge research and care for critically ill infants. Dr. del Moral’s responsibilities encompass teaching medical students, residents, and fellows, providing clinical care, and conducting research.  She is a member of the Hospital’s Medical Executive Committee and the University’s Medical Group Leadership Council.

  Dr. del Moral is the site principal investigator for a phase 3 clinical trial designed to evaluate the efficacy and safety of a drug for the prevention of necrotizing enterocolitis in very low-birth-weight infants. Other current research projects include a study on the impact of microbiota on body composition and growth, and a study looking at restoring airway symbiosis through the gut.

  Dr. del Moral is as an ad hoc reviewer of policies and guidelines for the American Academy of Pediatrics section of epidemiology. She also serves on the editorial board of Anales Españoles de Pediatria and as an ad hoc reviewer for the Journal of Pediatrics, Neonatology, and the Journal of Perinatal Medicine.

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  Teresa del Moral, MD, MPH, PhD

  Professor of Pediatrics
  University of Miami Leonard M. Miller School of Medicine
  Neonatal-Perinatal Medicine
  Jackson Memorial Hospital
  Miami, Florida