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IRCT2013020512370N1 IRCT 2013-05-12 Shiraz University of Medical Sciences A prospective study on The additive effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonate under phototherapy A prospective study on The additive effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonate under phototherapy 2012-12-21 anticipated 80 Complete https://irct.ir/trial/12434 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Indirect hyperbilirubinemia in neonate. Intervention 1: First group was given ursodeoxycholic acid 10-15 mg/kg divided q12h before starting phototherapy till exclusion from study. In the first day, laboratory tests included estimation of total bilirubin (direct and indirect), blood group including rh of the mother and neonate, complete blood count (cbc), g6pD activity, coombs test, reticulocyte count. Direct and indirect, as well as tsb were measured every 24 hours by the same laboratory till total serum bilirubin dropped under 10 mg/dl. The duration of phototherapy was recorded with a timer. Intervention 2: Second group that is control group received no medications and only underwent phototherapy.

public Ghashghaei Saadi Elham MD

Pediatric office ward, Namazi hospital

Shiraz Iran (Islamic Republic of) 713451978 +98 71 1612 5477 elhamghashghaei @yahoo.com; ghashghaei@sums.ac.ir Shiraz University of Medical Sciences scientific Honar Naser MD

Namazi hospital pediatric office ward

Shiraz Iran (Islamic Republic of) 71345-1978 +98 71 1612 5477 honarr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: birth-weight 2500-4000 gr; gestational age between 38-41 weeks; breastfeeding neonate; total bilirubin 14-20 mg/dl and neonates age older than three days. Exclusion criteria: infants with incompatible ABO, Rh; G6PD deficiency; direct hyper billirubinemia; septicemia or diseases that are implicated in causing jaundice; premature infants; infants of diabetic mothers. 3 years 28 years Both P59.9 Physiological jaundice (intense)(prolonged) NOS Treatment - Drugs N/A First group was given ursodeoxycholic acid 10-15 mg/kg divided q12h before starting phototherapy till exclusion from study. In the first day, laboratory tests included estimation of total bilirubin (direct and indirect), blood group including rh of the mother and neonate, complete blood count (cbc), g6pD activity, coombs test, reticulocyte count. Direct and indirect, as well as tsb were measured every 24 hours by the same laboratory till total serum bilirubin dropped under 10 mg/dl. The duration of phototherapy was recorded with a timer. Second group that is control group received no medications and only underwent phototherapy. Duration of need phototherapy. Timepoint: Since start study till finish study. Method of measurement: Timer. Serum total bilirubin. Timepoint: Since start study &12, 24, 36, 48 hour. Method of measurement: Blood sample. Shiraz University of Medical Sciences Approved 2012-09-20 shiraz university of medical science shiraz university of medical scienc,zand street,shiraz shiraz Iran (Islamic Republic of)