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IRCT20190604043813N2 IRCT 2020-03-31 Shiraz University of Medical Sciences The effect of Ursodeoxycholic Acid on neonatal jaundice Evaluating the Effect of Ursodeoxycholic Acid on total bilirubin of neonate with neonatal indirect hyperbilirubinemia who have Glucose-6-phosphate dehydrogenase deficiency compare to control group 2020-04-20 anticipated 50 Complete https://irct.ir/trial/46627 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization list with block size of 4 generates by https://www.sealedenvelope.com/simple-randomiser/v1/lists.The sample size , size of blocks and study groups are given to the system, and the system determines the order of the blocks and the order in each block in a list. The drug and placebo are arranged in a box according to the list by a pharmacist and are given to one of the nurses responsible for the research to be given to the infants, Blinding description: The drug and placebo which are prepared in syrup and are distinguishable by A and B labels will be arrange in a box according to the randomization list by the pharmacist who has no responsibility for patients care . The box will be given to a nurse who is unaware of the intervention type and she give the treatment in specified order . Caregivers, physicians, and the lab conducting the bilirubin test are not aware of the treatment. The results are compiled and analyzed by a statistician who is not aware of the intervention type. 3 Neonatal indirect hyperbilirubinemia. Intervention 1: Intervention group: The intervention group will receive oral drug of Ursodeoxycholic acid (UDCA) 10 mg/kg (2cc/kg) daily divided into 2 doses every 12 hours. Dr. Obidi's 300 mg capsule is used for the preparation of the syrups of 300 mg in 60 ml water. Both intervention and control groups receive standard phototherapy and the baby's eye and genitalia are covered. The drug is continued until the bilirubin level is below 10 mg /dl. Intervention 2: Control group: At 12 hours intervals, the control group received the same volume placebo syrup (1cc/kg). Both groups receive standard phototherapy and the baby's eye and genitalia are covered. The placebo is continued until the bilirubin level is below 10 mg /dl. Yes - There is a plan to make this available What will be shared: All data without name, protocol, and study report can be shared When: 6 months after publication To whom: all people who request to access the documents Conditions: With reference to the original study , data will be available for systematic review and meta-analysis. Where to obtain: hhaghighi@sums.ac.ir How to obtain: request send via email mentioned above Comments:
public Hourvash Akbari Haghighinejad
Family Medicine Department, Namazi Hospital, Zand Street,
Shiraz Iran (Islamic Republic of) 7194983858 00897136474967 hhaghighi@sums.ac.ir Shiraz University of Medical Sciences scientific Mehrdad Rezaie
Family medicine Department, Namazi Hospital, Zand street.
Shiraz Iran (Islamic Republic of) 7184983858 +98 71 3647 4967 md_rezaie@yahoo.co.uk Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Exclusive breastfeeding, Total bilirubin levels above 14 mg / dL and below 20 mg / dL, Direct bilirubin levels below 2 mg / dL. Age above 1 day Glucose 6 phosphate dehydrogenase deficiency Parent consent 1 day 10 days Both Infection and septicemia Uunderlying disease such as heart and liver disease The diabetic mother Rh incompatibility P59.8 Neonatal jaundice from other specified causes Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive oral drug of Ursodeoxycholic acid (UDCA) 10 mg/kg (2cc/kg) daily divided into 2 doses every 12 hours. Dr. Obidi's 300 mg capsule is used for the preparation of the syrups of 300 mg in 60 ml water. Both intervention and control groups receive standard phototherapy and the baby's eye and genitalia are covered. The drug is continued until the bilirubin level is below 10 mg /dl. Control group: At 12 hours intervals, the control group received the same volume placebo syrup (1cc/kg). Both groups receive standard phototherapy and the baby's eye and genitalia are covered. The placebo is continued until the bilirubin level is below 10 mg /dl. Total bilirubin. Timepoint: Every 24 hours until total bilirubin fall bellow 10 mg/dl. Method of measurement: Total bilirubin is measured by the diazo method. Median admission time. Timepoint: Once. Method of measurement: The number of hospitalization days. Shiraz University of Medical Sciences Approved 2017-11-22 Ethics committee of research of Shiraz Medical School ّFamily medicine department , Namazi Hospital, Zand street Shiraz Fars Iran (Islamic Republic of)