IRCT2017013028154N1 IRCT 2017-06-11 Vice chancellor for research of Shiraz University of Medical Sciences Effect of ursodeoxycholic acid on breast milk jaundice A prospective study on the effect of ursodeoxycholic acid on breast milk jaundice in neonate 2017-02-03 anticipated 80 Complete https://irct.ir/trial/22900 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The method of randomization is the four-block method. 1-2 Breast milk jaundice. Intervention 1: Intervention group: Intervention group includes 40 neonates with breast milk jaundice that treat with phototherapy (home or hospital) and URSODEOXYCHOLIC ACID 10 mg/kg/day (CAPSULE ORAL 300 mg) orally divides every 12 hours. The drug is given to them by a pharmacist. Total bilirubin level is measured 12, 24 and 48 hours after phototherapy until bilirubin levels fall below 12 and phototherapy is discontinued. Two groups are compared in terms of total bilirubin levels at different times and duration of phototherapy. Written informed consent is taken from patients before the study. The URSODEOXYCHOLIC ACID is in capsule form 300 mg from Pharmaceutical Co. Alborz Darou. The drug is given to neonate by a pharmacist in a dose of 10 mg/kg divided two times in a day and there is no interaction between feeding and this drug. Intervention 2: Control group: The control groups include 40 infants who receiving placebo (distilled water) and phototherapy (home or hospital). Total bilirubin level is measured 12, 24 and 48 hours after phototherapy until bilirubin levels fall below 12 and phototherapy is discontinued. Two groups are compared in terms of total bilirubin levels at different times and duration of phototherapy. Written informed consent is taken from patients before study.