Bifidobacteriumlongum subsp. infantis EVC001 Administration Is Associated with a Significant Reduction in the Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants

J Pediatr. 2022 May:244:64-71.e2. doi: 10.1016/j.jpeds.2021.12.070. Epub 2022 Jan 12.

Abstract

Objective: To assess the effects of Bifidobacteriumlongum subsp. infantis EVC001 (Binfantis EVC001) administration on the incidence of necrotizing enterocolitis (NEC) in preterm infants in a single level IV neonatal intensive care unit (NICU).

Study design: Nonconcurrent retrospective analysis of 2 cohorts of very low birth weight (VLBW) infants not exposed and exposed to Binfantis EVC001 probiotic at Oregon Health & Science University from 2014 to 2020. Outcomes included NEC incidence and NEC-associated mortality, including subgroup analysis of extremely low birth weight (ELBW) infants. Log-binomial regression models were used to compare the incidence and risk of NEC-associated outcomes between the unexposed and exposed cohorts.

Results: The cumulative incidence of NEC diagnoses decreased from 11.0% (n = 301) in the no EVC001 (unexposed) cohort to 2.7% (n = 182) in the EVC001 (exposed) cohort (P < .01). The EVC001 cohort had a 73% risk reduction of NEC compared with the no EVC001 cohort (adjusted risk ratio, 0.27; 95% CI, 0.094-0.614; P < .01) resulting in an adjusted number needed to treat of 13 (95% CI, 10.0-23.5) for Binfantis EVC001. NEC-associated mortality decreased from 2.7% in the no EVC001 cohort to 0% in the EVC001 cohort (P = .03). There were similar reductions in NEC incidence and risk for ELBW infants (19.2% vs 5.3% [P < .01]; adjusted risk ratio, 0.28; 95% CI, 0.085-0.698 [P = .02]) and mortality (5.6% vs 0%; P < .05) in the 2 cohorts.

Conclusions: In this observational study of 483 VLBW infants, Binfantis EVC001 administration was associated with significant reductions in the risk of NEC and NEC-related mortality. Binfantis EVC001 supplementation may be considered safe and effective for reducing morbidity and mortality in the NICU.

Keywords: Bifidobacterium infantis EVC001; NEC; VLBW; dysbiosis; gut microbiome; human milk; necrotizing enterocolitis; neonate; preterm.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Birth Weight
  • Enterocolitis, Necrotizing* / epidemiology
  • Enterocolitis, Necrotizing* / etiology
  • Enterocolitis, Necrotizing* / prevention & control
  • Humans
  • Incidence
  • Infant
  • Infant, Extremely Low Birth Weight
  • Infant, Newborn
  • Infant, Newborn, Diseases*
  • Infant, Premature
  • Infant, Very Low Birth Weight
  • Retrospective Studies