Objectives: The goal was to investigate the effect of orally administered synbiotics on outcome of infants with cyanotic congenital heart disease (CCHD).
Methods: A prospective, blinded, randomized controlled trial was conducted to evaluate the effect of synbiotics on outcome of infants with CCHD. The infants with CCHD were assigned randomly to 2 groups. Infants in the study group were given synbiotic (Bifidobacterium lactis plus inulin) added to breast milk or mixed feeding until discharge or death. Infants in the placebo group were fed with breast milk or mixed feeding. The outcome measurements were nosocomial sepsis, necrotizing enterocolitis (NEC; Bell stage ≥ 2), length of NICU stay, and death.
Results: A total of 100 infants were enrolled in the trial: 50 in each arm. There were 9 cases of culture-proven sepsis (18%) in the placebo group and 2 cases (4%) in the synbiotic group (P = .03). Length of NICU stay did not differ between the groups (26 [14-36] vs 32 days [20-44], P = .07]. There were 5 cases of NEC (10%) in the placebo group and none in the synbiotic group (P = .03). The incidence of death was lower in synbiotic group (5 [10%] of 50 vs 14 [28.0%] of 50, respectively; P = .04).
Conclusions: Synbiotics administered enterally to infants with CCHD might reduce the incidence of nosocomial sepsis, NEC, and death.
Trial registration: ClinicalTrials.gov NCT01810978.
Keywords: cyanotic congenital heart disease; necrotizing enterocolitis; sepsis; synbiotics.