Effect of a Dual-Strain Probiotic on Necrotizing Enterocolitis in Neonates with Ductal-Dependent Congenital Heart Disease: A Retrospective Cohort Study

Background: Newborns with ductal-dependent congenital heart disease (CHD) are at increased risk for developing necrotizing enterocolitis (NEC). Objectives: To investigate whether the use of dual-strain probiotics is beneficial for prevention of NEC in CHD patients, as demonstrated for premature infants. Study Design: Single-center retrospective cohort study of newborns with ductal-dependent CHD before and after implementation of oral dual-strain probiotics containing Bifidobacterium infantis and Lactobacillus acidophilus, on each day of exposure to prostaglandin E1 (PGE1). Results: Birth weight, gestational age, and distribution of heart defects were similar in both cohorts. NEC occurred in 6 of 247 (2.4%) patients without probiotics, and in 3 of 242 (1.2%) patients who received probiotics (p = 0.504). NEC-related mortality (0.4 vs. 0.4%, p = 1.000) and overall mortality (11.0 vs. 8.7%, p = 0.448) were likewise not different. PGE1 exposure was 1,788 and 2,455 days, respectively. In subgroup analysis of 152 infants with aortic arch malformations, such as coarctation of the aorta and interrupted aortic arch, we observed a significant reduction of NEC frequency (5.6 vs. 0.0%, p = 0.048). Conclusions: This is the first study to investigate the effect of a dual-strain probiotic on NEC in CHD patients. Infants with aortic arch malformations appear to benefit from dual-strain probiotics. Due to the scarcity of concurrence of ductal-dependent CHD and NEC, a clinical trial on probiotics to decrease risk of NEC in infants with ductal-dependent CHD would require several thousand infants.