Efficacy and safety of probiotics in neonatal hyperbilirubinemia: Randomized controlled trial

Abstract

IntroductionThere have been many studies evaluating the role of probiotics in the management of necrotizing enterocolitis (NEC), yet few studies related to the role of probiotics in the management of neonatal jaundice. The purpose of this study was to determine the efficacy and safety of utilizing probiotics in the management of neonatal hyperbilirubinemia. MethodsThis study was a single blinded randomized clinical trial conducted on 2–28 day old term and near-term infants (35–42 weeks gestational age) that were hospitalized with neonatal jaundice in Bandar Abbas, Iran in 2016. The primary outcome of this study was to evaluate the duration of hospitalization in neonates with neonatal jaundice. Secondary outcomes were to determine the percentage of infants who needed phototherapy on the 2nd, 3rd, 4th, and 5th days of admission. Data were analyzed by SPSS software and descriptive statistics and Chi-square and independent samples t-test. ResultsOne hundred and twenty-six (126) breastfed infants were enrolled in this study and randomly assigned to one of two groups. The non-probiotic group included 61 (48.4%) patients and the probiotic group included 65 (51.6%) patients. Duration of hospitalization was 3.10 ± 0.569 days in the non-probiotic group versus 3 ± 0.901 in the probiotic group (p = 0.469). The percentage of patients discharged in the probiotic group was significantly higher in comparison to the non-probiotic group on the 3rd day of admission (p = 0.008) and Discharged early. The percentage of patients discharged were similar between the two groups on the 2nd, 4th, and 5th days of admission (p > 0.05). ConclusionProbiotics are not effective in lowering the duration of phototherapy in infants with hyperbilirubinemia. Although probiotics can increase the rate of discharge on the 3rd day of admission in infants with neonatal hyperbilirubinemia, the rate of hospital discharge was not different in the probiotic and non-probiotic groups on the 2nd, 4 th, and 5 th days of admission. ClinicalTrials.gov Identifier: NCT03266913.