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

Background and Objective: Considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia. Materials and Methods: This study was a single blinded randomized clinical trial and was conducted on term and near-term infants 2 to 28 days old with neonatal jaundice with gestational age of 35-42 weeks who were hospitalized in Bandar Abbas in Iran in 2016. The primary outcome of the study was duration of hospitalization. The secondary outcomes were percentage of infants who need phototherapy at 2nd, 3rd, 4th, and 5th day of admission. Data were analyzed by SPSS software. ClinicalTrials.gov Identifier: NCT03266913 Findings :In this study, we enrolled 126 breastfed infants. We included 61 (48.4 %) patients in no probiotic group and 65 (51.6 %) in probiotic group. Duration of hospitalization was 3.10 ± 0.569 days in non-probiotic group versus 3 ± 0.901 in probiotic group (p = 0.469). The percentage of patients discharged in probiotic group was significantly higher in comparison to non-probiotic group in 3rd day of admission (p = 0.008). Conclusion: Probiotics are not effective in lowering the duration of phototherapy in infants with hyperbilirubinemia. Although probiotics can increase the rate of discharge in 3rd day of admission in infants with neonatal hyperbilirubinemia, but the rate of hospital discharge is not different in probiotic and no probiotic groups in 2nd, 4th, and 5th day of admission.

کلیدواژه ها:

neonatal hyperbilirubinemia ، probiotic ، phototherapy