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Updated: Sep 10, 2025

Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Probiotic Receipt and Neurodevelopmental Outcomes of Infants <29 Weeks' Gestation: A Cohort Study
Prakesh S Shah1, Nicole Bando2, Seungwoo Lee2
1Department of Pediatrics, Sinai Health, Toronto, Ontario, Canada; Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada.
Objective:
To examine neurodevelopment and growth following probiotic receipt in neonatal intensive care units.
Study Design:
A national, population-representative, multicenter, retrospective cohort study was conducted on children born at <29 weeks' gestation between January 1, 2014, and December 31, 2020, from 21 neonatal units in Canada who survived and then underwent follow-up between ages 18 and 30 months. Children who received vs did not receive probiotics were compared for the primary outcome of significant neurodevelopmental impairment, defined as any of the following: Bayley Scales of Infant and Toddler Development-III cognitive, language, or motor score <70; cerebral palsy with Gross Motor Function Classification System III-V; hearing aid or cochlear implant; or bilateral visual impairment. Equivalence analyses utilizing a 4% margin for outcomes between groups were conducted using logistic regression and propensity score-matched analyses to calculate adjusted risk difference (RD) and CIs.
Results:
A total of 2749 children in the probiotics group (median gestation 26 weeks and birth weight 920 grams) and 2442 in the no probiotics group (median gestation 26 weeks and birth weight 890 grams) were evaluated. Baseline characteristics were similar between groups. For the outcome of significant neurodevelopmental impairment, logistic regression analyses indicated that probiotics were equivalent to no probiotics (adjusted RD -0.23%, 95% CI: 2.61%, 2.15%), whereas propensity score-matched analyses (1474 pairs of children) indicated probiotics were nonequivalent and potentially superior (adjusted RD -4.01%, 95% CI: 6.92%, -1.01%). Results of the majority of secondary outcomes were similar, including growth outcomes.
Conclusions:
Probiotics were not associated with harm in neurodevelopment and growth of surviving preterm neonates and may be potentially superior to no probiotics for neurodevelopment and growth among surviving preterm neonates <29 weeks' gestation.

