TY - JOUR
T1 - Bifidobacterium longum subsp. infantis EVC001 Administration Is Associated with a Significant Reduction in the Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants
AU - Tobias, Joseph
AU - Olyaei, Amy
AU - Laraway, Bryan
AU - Jordan, Brian K.
AU - Dickinson, Stephanie L.
AU - Golzarri-Arroyo, Lilian
AU - Fialkowski, Elizabeth
AU - Owora, Arthur
AU - Scottoline, Brian
N1 - Publisher Copyright:
© 2022 The Author(s)
PY - 2022/5
Y1 - 2022/5
N2 - 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.
AB - 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.
KW - Bifidobacterium infantis EVC001
KW - NEC
KW - VLBW
KW - dysbiosis
KW - gut microbiome
KW - human milk
KW - necrotizing enterocolitis
KW - neonate
KW - preterm
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UR - http://www.scopus.com/inward/citedby.url?scp=85124561952&partnerID=8YFLogxK
U2 - 10.1016/j.jpeds.2021.12.070
DO - 10.1016/j.jpeds.2021.12.070
M3 - Article
C2 - 35032555
AN - SCOPUS:85124561952
SN - 0022-3476
VL - 244
SP - 64-71.e2
JO - Journal of Pediatrics
JF - Journal of Pediatrics
ER -