Efficacy and safety of probiotics in neonatal hyperbilirubinemia: Randomized controlled trial |
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| Affiliation: | 1. Department of Neonatology, Clinical Research Development Center of Children''s Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran;2. Clinical Research Development Center of Children''s Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran;3. Fellowship of Pediatric Gastroenterology and Hepatology, Department of Pediatric Gastroenterology, Shiraz University of Medical Sciences, Shiraz, Iran;4. Student Research Committee, Jahrom University of Medical Sciences, Jahrom, Iran;1. Department of Pediatrics and Child Health Nursing, College of Health Sciences, Debre Tabor University, P.O.BOX 272, Debre Tabor, Ethiopia;2. Department of Emergency Medicine and Critical Care Nursing, College of Health Sciences Debre Tabor University, P.O.BOX 272, Debre Tabor, Ethiopia;3. Department of Medicine, College of Health Sciences, Debre Tabor University, P.O.BOX 272, Debre Tabor, Ethiopia;4. Department of Public Health, College of Health Sciences, Debre Markos University, P.O.BOX 269, Debre Markos, Ethiopia;5. Department of Anesthesia, College of Health Sciences, Debre Tabor University, P.O.BOX 272, Debre Tabor, Ethiopia;6. Department of Midwifery, College of Health Sciences, Debre Tabor University, P.O.BOX 272, Debre Tabor, Ethiopia;7. Departments of Epidemiology, College of Health Sciences, Bahir Dar University, P.O.BOX 272, Bahrdar, Ethiopia;8. Department of Nursing, College of Health Sciences, P.O.BOX 272, Bahir Dar, Ethiopia;9. Department of Medical Nursing, School of Nursing, College of Medicine and Health Sciences, University of Gonder, P.O.BOX 196, Gonder, Ethiopia;10. Department of Health Systems and Policy, College of Medicine and Health Sciences, University of Gonder, P.O.BOX 196, Gonder, Ethiopia;1. Princess Elizabeth Hospital, Neonatal Unit, Guernsey;2. The Townsville Hospital, Neonatal Unit, Townsville, Queensland, Australia;3. James Cook University, Townsville, Queensland, Australia;1. Department of Midwifery and Women''s Health, Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan;2. Department of Health Quality and Outcome Research, Division of Nursing Systems, Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;3. Allergy Center, National Center for Child Health and Development, Tokyo, Japan;1. Pediatric Nursing Department, Faculty of Nursing, Alexandria University, Egypt;2. Pediatric Nursing Department, Faculty of Nursing, Matrouh University, Egypt;3. Pediatric Nursing Specialty, Nursing Department, College of Health and Sport Sciences, University of Bahrain, Zallaq, Bahrain;4. Midwifery Specialty, Nursing Department, College of Health and Sport Sciences, University of Bahrain, Zallaq, Bahrain;1. Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India;2. College of Nursing, All India Institute of Medical Sciences, New Delhi, India |
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| 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. |
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| Keywords: | Neonatal Hyperbilirubinemia Probiotic Phototherapy Discharge |
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