Patients and settings
Gilbert’s syndromes, Crigler-Najjar, hyperbilirubinemia, sepsis, breast milk
HYPOTHYROIDISM, GLUCOSE 6 PHOSPHATE DEHYDROGENASE DEFICIENCY, MATERNAL DIABETES, CHRONIC DISEASES, LIVER DISEASE, DIRECT HYPERBILIRUBINEMIA, HYPERBILIRUBINEMIA, SEPSIS, DISEASES
The present study is a paralleled randomized single-blinded controlled clinical trial that was performed from 10 April 2021 to 10 October 2021 for 6 months. In this study, 106 term neonates were admitted for at least 48 hours due to indirect hyperbilirubinemia in the neonatal ward of 17 Shahrivar Hospital in Rasht, Iran.This study was approved by the ethics committee of the Vice-Chancellor of Research at Guilan University of Medical Sciences (Number: IR.GUMS.REC.1399.645, Date: 2021-03-03). The clinical trial was registered in the Iranian registry of clinical trials (Number: IRCT20210201050199N1, Date: 2021-04-03). The authors confirm that all ongoing and related trials for this drug/intervention are registered. Written Informed consent letter was obtained from parents or guardians.The inclusion criteria were 3 to 7 days of age, 2500 to 4000 grams birth weight, exclusive breastfeeding, 38 to 42 weeks of gestation, 14–20 mg/dL total serum bilirubin (TSB), and less than 1.5 mg/dL direct bilirubin. Neonates were excluded if there was ABO and Rh incompatibility, glucose 6 phosphate dehydrogenase deficiency (G6PDd), history of any neurological or chronic diseases, sepsis, diseases leading to hyperbilirubinemia (e.g., Crigler-Najjar and Gilbert’s syndromes, hypothyroidism, and liver disease) and a history of maternal diabetes as well as parental dissatisfaction.Eligible patients were randomly allocated by randomized blocking (or grouping). The following website “The intervention group received 10 mg/kg/day oral UDCA divided into two doses plus phototherapy, which was dissolved in breast milk (Amin Pharmaceutical Company, Iran). The control group received phototherapy alone. The method of phototherapy was the same in both groups. Based on the AAP guideline [Sample size was indicated based on Shahramian et al. [n10% drop rate = 5N = 53 in each group