]>
IRCT20170719035178N2 IRCT 2019-02-10 Sabzevar University of Medical Sciences Efficacy of Ursodeoxycholic acid in the treatment of indirect hyperbilirubinemia in neonates Investigating the efficacy of Ursodeoxycholic acid on indirect hyperbilirubinemia in neonates treated with phototherapy 2018-10-12 anticipated 88 Complete https://irct.ir/trial/34720 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization based on permutation. Accordingly, 22 blocks are allocated to patients, in each block 2 from A treatment group and 2 from the B treatment group were placed. Eventually, after completion of the blocks, group A is treated with Phototherapy and Ursodeoxycholic acid capsule and Group B is treated with Phototherapy, Blinding description: Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups. The clinician and practitioner are unaware of the groups. 3 Indirect Hyperbilirubinemia. Intervention 1: Intervention group: Patients in this group are treated by phototherapy and capsules of Urosobil (manufactured by Alborz Pharmaceuticals and dissolved in 10 cc infant milk) at 10 mg/kg daily for two days. Intervention 2: Control group: Patients in this group are treated by phototherapy for two days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mitrah Aldaghi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4411 1071 Aldaghim@medsab.ac.ir Sabzevar University of Medical Sciences scientific Mitrah Aldaghi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 514411071 Aldaghim@medsab.ac.ir Sabzevar University of Medical Sciences Iran (Islamic Republic of) Birth weight more than 2500 gr Gestational age more than 37 weeks The birthday more than 2 days and less than two weeks The total bilirubin level is 14-20 mg/dl and the direct bilirubin level is less than 2 mg/dl No Septicemia lack of Crigler–Najjar syndrome lack of Thyroid disease lack of Liver disease lack of direct hyperbilirubinemai Incompatibility of blood groups and RH lack of G6PD deficiency Infants aged 2 to 14 days 2 days 14 days Both Parental dissatisfaction for any reason The incidence of any side effects of Ursodeoxycholic acid Infants from diabetic mother P58.9 Neonatal jaundice due to excessive hemolysis, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group are treated by phototherapy and capsules of Urosobil (manufactured by Alborz Pharmaceuticals and dissolved in 10 cc infant milk) at 10 mg/kg daily for two days. Control group: Patients in this group are treated by phototherapy for two days Total bilirubin. Timepoint: The time intervals for measuring total bilirubin levels are at the baseline (before the intervention), 12, 24, and 36 hours after starting treatment (phototherapy with or without Ursobil). Method of measurement: Autoanalyzer devices. Drug side effects. Timepoint: During the intervention at 12, 24, and 36 hours after intervention. Method of measurement: Clinical evaluation. Sabzevar University of Medical Sciences Approved 2018-10-09 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)