Bifidobacterium longum subsp. infantis EVC001 Administration Is Associated with a Significant Reduction in the Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants - 06/05/22
Abstract |
Objective |
To assess the effects of Bifidobacterium longum subsp. infantis EVC001 (B infantis 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 B infantis 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 B infantis 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, B infantis EVC001 administration was associated with significant reductions in the risk of NEC and NEC-related mortality. B infantis EVC001 supplementation may be considered safe and effective for reducing morbidity and mortality in the NICU.
Le texte complet de cet article est disponible en PDF.Keywords : necrotizing enterocolitis, NEC, Bifidobacterium infantis EVC001, VLBW, neonate, preterm, gut microbiome, dysbiosis, human milk
Abbreviations : CHD, ELBW, HMO, NEC, NICU, NNT, OHSU, PMA, RR, SGA, VLBW
Plan
| Supported by grants from Evolve BioSystems, Inc. The study sponsors were involved in initial discussions concerning study design but were not involved in data collection, analysis, or interpretation or in the writing of or decision to submit the manuscript. B.S. serves as a member of the Infant Health Advisory Board of Evolve BioSystems, receiving no compensation for this role. The authors declare no conflicts of interest. |
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| Portions of the data contained in this paper were presented in poster or oral presentation form at the Pediatric Academic Society's 2021 Annual Meeting, the 2021 NEC Society Virtual Sessions, Cool Topics 2021, and Hot Topics 2020. |
Vol 244
P. 64 - mai 2022 Retour au numéro
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