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.
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.
