Study: Probiotics Led to Fewer Deaths of Preterm Infants in Canadian Neonatal Units

Probiotics used in Canadian neonatal units were associated with fewer deaths of preterm infants and had limited effects on reducing the risk of necrotizing enterocolitis (NEC) or late-onset sepsis, according to a study published in the March 2025 Pediatrics. The study, “Effectiveness and Risks of Probiotics in Preterm Infants” (published online Feb. 12), examined the infants born less than 34 weeks' gestation and less than 1000 grams birth weight who were admitted to Canadian neonatal units from 2016 through 2022. Of 32,667 infants, 18,793 (57.5%) received probiotics and 13,874 (42.5%) did not receive probiotics. Probiotics have emerged as a possible effective measure for preventing necrotizing enterocolitis, a life-threatening condition and the most prevalent gastrointestinal emergency in infants. The use of probiotics in preterm infants has been controversial due to the risk that probiotics may increase the risk of an infant developing probiotic sepsis due to immaturity of the immune system. Some cases of infant deaths prompted the U.S. Food and Drug Administration and Health Canada to issue warning letters regarding probiotics use in neonatal units. Researchers found fewer infant deaths in those who were given probiotics. Probiotic sepsis was rare and was considered a possible associated cause of death in two infants. The authors conclude: The clinical benefits of probiotic use in preterm infants, particularly reduced mortality, outweigh the rare incidence of probiotic sepsis and related fatalities. These findings may support neonatal clinicians in counseling parents of preterm infants in the NICU regarding the benefits and risks of probiotic use.

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The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.