For a study, researchers sought to determine how the administration of Bifidobacterium longum subsp. infantis EVC001 (B infantis EVC001) affected the incidence of necrotizing enterocolitis (NEC) in preterm newborns in a single level IV neonatal intensive care unit (NICU). Nonconcurrent retrospective investigation of two cohorts of very low birth weight (VLBW) children at Oregon Health & Science University from 2014 to 2020. The outcomes included NEC incidence and NEC-related death, as well as a subgroup analysis of infants with extremely low birth weight (ELBW). To examine the incidence and risk of NEC-related outcomes in the unexposed and exposed groups, log-binomial regression models were utilized.
The cumulative incidence of NEC diagnoses fell from 11.0% (n = 301) in the no EVC001 (unexposed) group to 2.7% (n = 182) in the EVC001 (exposed) cohort (P<.01). When compared to the no EVC001 group, the EVC001 cohort showed a 73% risk reduction of NEC (adjusted risk ratio, 0.27; 95% CI, 0.094-0.614; P<.01), resulting in an adjusted number required to treat 13 (95% CI, 10.0-23.5) for B infantis EVC001. NEC-related mortality fell from 2.7% in the no EVC001 group to 0%in the EVC001 cohort (P =.03). In all cohorts, there were similar decreases in NEC incidence and risk for ELBW babies (19.2% vs 5.3% [P<.01]; adjusted risk ratio, 0.28; 95% CI, 0.085-0.698 [P =.02]) and death (5.6% vs 0%; P<.05). B infantis EVC001 treatment was linked with substantial decreases in the risk of NEC and NEC-related death in this observational trial of 483 VLBW babies. Supplementation with B infantis EVC001 may be deemed safe and helpful for lowering morbidity and mortality in the NICU.