346 - B. Infantis EVC001 Administration in VLBW Infants is Associated with a Significant Reduction in the Incidence of Spontaneous Intestinal Perforation

Spontaneous intestinal perforation (SIP) is a poorly understood condition affecting 2-3% of very low birth weight (VLBW) infants within the first 10-14 days of life (DOL). SIP is defined by isolated bowel/ileal perforation and is classically thought to be distinct from necrotizing enterocolitis (NEC) due to the lack of systemic illness that is a hallmark of modified Bell stage ≥2a NEC. Although SIP is often thought of as benign, it is, similar to surgical NEC, associated with mortality and is a major cause of morbidity in VLBW infants. Unlike NEC, SIP risk has not been associated with dysbiosis.



Objective:

To measure SIP incidence in cohorts of VLBW infants before and after the introduction of Bifidobacterium longum ssp infantis (B. infantis) EVC001 at a single Level IV NICU.

Design/Methods:

The study is single-center, retrospective, and observational. Chart review evaluated 2 VLBW infant cohorts for demographics and SIP at OHSU between Jan 2014 and Aug 2022. The comparison cohort (n=301) did not receive a probiotic, while B. infantis EVC001 administration was standard of care from Jun 2018 onward for the EVC001 cohort (n=215). The EVC001 cohort was restricted to VLBW infants who received at least one EVC001 dose before DOL 10. 

Results:

The two cohorts in this study had no significant differences in the proportion of females, method of delivery, proportion of small for gestational age, or congenital heart disease. The EVC001 cohort had a higher mean birthweight than the pre-EVC001 cohort (1112 g vs. 1045 g; p = 0.007) and a slightly higher mean gestational age (28.9 weeks vs. 28.3 weeks; p = 0.004) (Table 1). There were 11 cases of SIP (3.7%) in the pre-EVC001 cohort compared to 1 case of SIP (0.5%) after implementation of EVC001 administration in the VLBW cohort that received at least one dose of EVC001 before DOL 10. None of the SIP cases in either epoch was associated with coadministration of indomethacin and a systemic corticosteroid.  The decrease is significant (p = 0.018, Fisher’s Exact test) with a risk ratio of 0.127 (95% confidence interval: 0.017 - 0.978) (Table 2). There were no adverse effects related to B. infantis EVC001 administration. 

Conclusion(s):

We have previously reported a reduction in NEC incidence in VLBW infants associated with B. infantis EVC001 administration. We now show that EVC001 administration is associated with a significant reduction in the incidence of SIP in a single-center retrospective observational study of 516 VLBW infants. To our knowledge, this is the first report of a reduction SIP incidence in VLBW infants associated with the administration of a probiotic. 


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