Related Experiment Video
Updated: Jan 10, 2026
Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Unplanned natural experiment: probiotics prevent necrotizing enterocolitis, a single center quality improvement
Anne Denslow1, Gina O'Toole1, Sue Freck1
1Division of Neonatology, CHOC Children's, Orange, CA, USA.
Insights
Implementing a probiotic protocol safely reduced necrotizing enterocolitis (NEC) in premature infants. However, discontinuing probiotics due to a regulatory ban was associated with a rebound in NEC rates, highlighting the importance of these interventions.
Area of Science:
- Neonatal Medicine
- Pediatric Gastroenterology
- Quality Improvement Science
Background:
- Necrotizing enterocolitis (NEC) is a significant cause of morbidity and mortality in preterm infants.
- Implementing evidence-based protocols is crucial for managing common neonatal conditions.
- Previous studies suggest probiotics may reduce NEC incidence.
Purpose of the Study:
- To implement a probiotic protocol using quality improvement (QI) methodology to reduce NEC in very preterm infants.
- To assess the safety and efficacy of probiotics in preventing NEC.
- To evaluate the impact of a regulatory ban on probiotic use and NEC rates.
Main Methods:
- A multidisciplinary team developed and implemented an evidence-based probiotic protocol for infants born <32 weeks or <1500g.
- Protocol compliance, NEC rates, death, and sepsis were tracked as process, outcome, and balancing measures.
- Data were collected at baseline, during the QI initiative, and after probiotics were discontinued due to an FDA warning.
Main Results:
- Protocol compliance reached 84.5%, demonstrating successful implementation.
- The NEC rate decreased significantly from 4.6% at baseline to 0.6% post-implementation.
- Following the FDA warning and discontinuation of probiotics, the NEC rate increased to 3.8% (p=0.045), with no associated deaths or sepsis in probiotic recipients.
Conclusions:
- The QI initiative successfully and safely implemented probiotics, leading to a significant reduction in NEC.
- The regulatory discontinuation of probiotics was associated with a concerning rebound in NEC rates.
- This study underscores the benefits of probiotics in preventing NEC in high-risk infants.
Objective:
To reduce necrotizing enterocolitis (NEC) in infants born <32 weeks or <1500 g by implementing probiotics protocol using quality improvement (QI) methodology. Probiotics were discontinued following the FDA warning.
Methods:
Multidisciplinary team developed an evidence-based protocol and identified key drivers for implementation. Protocol compliance was the process measure. NEC rate was the outcome measure tracked at baseline, during the QI initiative, and after the FDA warning. Death and sepsis were the balancing measures.
Results:
Protocol compliance was 84.5%. The baseline NEC rate was 4.6%, decreased in the post-implementation group to 0.6%, then increased following the FDA warning to 3.8% (p = 0.045). Two special cause variations were observed in relation to implementing and discontinuing probiotics. None of the infants who received probiotics died or developed probiotics associated sepsis.
Conclusions:
QI initiative safely implemented probiotics and reduced NEC. The regulatory ban of probiotics was associated with a rebound in NEC rate.
