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IRCT20201118049433N1 IRCT 2020-12-10 Islamic Azad University The effect of adding fenofibrate to phenobarbital in the treatment of prolonged neonatal jaundice Comparison of the effect of adding a single dose of fenofibrate to phenobarbital in the treatment of prolonged neonatal jaundice with phenobarbital alone 2020-08-09 anticipated 60 Complete https://irct.ir/trial/52481 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, we used a simple randomization method. The number of 60 eligible infants who referred to the neonatal clinic consecutively was numbered from 01 to 60 in order of referral time. Then the rand function of Excel software was used for randomization. The neonates were divided into two groups of 30 A(phenobarbital or control group) and B(fenofibrate+ phenobarbital group). 3 Prolonged neonatal jaundice. Intervention 1: In this group, phenobarbital tablets with a dose of 10 mg/kg on the first day and then with a dose of 5 mg/kg until the fifth day, are given orally daily. Intervention 2: Intervention group: In this group, a single dose of fenofibrate capsules at a dose of 10 mg/kg with phenobarbital tablets at a dose of 10 mg/kg on the first day and then at a dose of 5 mg/kg until the fifth day, is given orally daily. 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 There is no more information
public Mohammad Golshan Tafti
Dr. Golshan office, Golchin Ave., Taleghani Blvd., Yazd Town
Yazd Iran (Islamic Republic of) 8915145653 +98 35 3725 8060 mgolshan035@gmail.com Islamic Azad University scientific Mohammad Golshan Tafti
Dr. Golshan office, Golchin Ave., Taleghani Blvd., Yazd Town
Yazd Iran (Islamic Republic of) 8915145653 +98 35 3725 8060 mgolshan035@gmail.com Islamic Azad University Iran (Islamic Republic of) Infants who are full-term (gestational age between 37 and 41 weeks) All infants between the ages of 14 and 40 days All infants weighing between 2500 and 4000 grams Infants who are breastfed All infants with total bilirubin 10 to 20 mg/dL Infants who show no signs of hemolysis on a blood test Infants who do not have symptoms of an infectious disease or any abnormality 14 days 40 days Both Infants who are dehydrated Infants who test positive for Coombs Infants with indirect bilirubin more than 2 mg/dL Treatment - Drugs Treatment - Drugs In this group, phenobarbital tablets with a dose of 10 mg/kg on the first day and then with a dose of 5 mg/kg until the fifth day, are given orally daily. Intervention group: In this group, a single dose of fenofibrate capsules at a dose of 10 mg/kg with phenobarbital tablets at a dose of 10 mg/kg on the first day and then at a dose of 5 mg/kg until the fifth day, is given orally daily. Total bilirubin. Timepoint: At the beginning of the study (before the intervention) and 7 days after the start of the procedure. Method of measurement: Bilirubin meter. Islamic Azad University Approved 2020-08-09 Ethics Committee of Islamic Azad University of Yazd Research unit, Ali Ibn Abitaleb Medical School, Islamic Azad University Of Yazd, Shohada Gomnam Boulevard, Safaeieh Yazd Yazd Iran (Islamic Republic of)