709 - Incidence of necrotizing enterocolitis after stopping probiotics - a community hospital system perspective

Publication Number: 709.5441

Dhruv Gupta, Pediatrix, El Paso, El Paso, TX, United States; Fernando Najar, Pediatrix Medical Group, El Paso, TX, United States; Marcella Mascher-Denen, Pediatrix, Pagosa Springs, CO, United States; Marryam Khan, Pediatrix Medical Group, El Paso, TX, United States; Anne C. Kotto-Kome, Pediatrix Medical Group, Las Cruces, NM, United States; Naima Frewan, Pediatrix, El Paso, TX, United States; Jenifer Gehlsen, The Children's Hospital at Providence, El Paso, TX, United States; Benjamin Shapleigh, Pediatrix, El Paso, TX, United States; Gregory Welch, Pediatrix, El Paso, TX, United States

Background: In 2023, the Food and Drug Administration raised concerns about probiotic products used to treat or prevent necrotizing enterocolitis in infants. Specifically, on October 24, 2023, they issued a warning letter to Abbott Laboratories for selling an unlicensed biological product that claimed to reduce the incidence of necrotizing enterocolitis. Our neonatology practice routinely used probiotics on preterm infants across seven different neonatal intensive care units, from January 2020 onwards. After this concern was raised, our practice stopped using probiotics, starting November 2023

Objective: To assess the incidence of any stage 2 and stage 3 necrotizing enterocolitis before and after stopping probiotic use in preterm infants

Design/Methods: The main outcome measure was incidence of any documented stage 2 and stage 3 necrotizing enterocolitis. Data was collected using Pediatrix® clinical data warehouse. Chi square test was used to compare necrotizing enterocolitis rates stratified by gestational age, from January 2020 to October 2023 (probiotic epoch) and November 2023 to October 2024 (no probiotic epoch). Inclusion criteria was gestational age less than or equal to 28 weeks, with no exclusion criteria

Results: A total of 331 infants were analyzed. 12 cases of either stage 2 or stage 3 necrotizing enterocolitis were documented in the probiotic epoch and a total of 7 were documented in the no probiotic epoch. 3.5% (2/58) of infants born at 22-24 weeks gestational ages had stage 2 or stage 3 necrotizing enterocolitis during the probiotic epoch vs 12.5% (4/32) during the no probiotic epoch ( p value 0.09). During the same time period, for infants born between 25-28 weeks gestational age, incidence of stage 2 or stage 3 necrotizing enterocolitis was 5.6% (10/178) in the probiotic epoch and 4.8% (3/63) in the no probiotic epoch (p value 0.80)

Conclusion(s): A trend was noted towards an increase in stage 2 and stage 3 necrotizing enterocolitis rates in infants born between 22 and 24 weeks gestational age, after probiotic use was stopped in various community neonatal intensive care units, managed by a single medical practice. Limitations of this study are that it is a retrospective review with no adjustment for individual risk factors. Strengths of this study are that the clinical practice feeding guidelines remained same for all preterm infants during the entire study period, with probiotic use being the main difference between the two study groups

Incidence of necrotizing enterocolitis (NEC) statified by gestational age in percentage (%)