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IRCT20250722066600N1 IRCT 2025-08-18 Ilam University of Medical Sciences Studying the effect of clofibrate on reducing prolonged jaundice in newborns Evaluation of the therapeutic effect of clofibrate on reducing prolonged indirect hyperbilirubinemia in term neonates 2024-09-22 anticipated 120 Complete https://irct.ir/trial/85095 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were randomly assigned to groups using a random number table. The random sequence was generated by an independent individual not involved in data collection or analysis. The allocation sequence was kept confidential to minimize allocation bias, Blinding description: Due to the clear difference between the intervention and control groups (use of clofibrate in the intervention group and not in the control group), blinding of participants and care providers was not feasible. However, the data analyst was blinded to the group assignments, and allocation information was not disclosed until the completion of data analysis. 2-3 Prolonged Indirect Hyperbilirubinemia in Term Neonates. Intervention 1: Intervention group: in this group , term neonates with prolonged Unconjugated Hyperbilirubinemia , recieves oral clofibrate at a dose of 50 mg/kg as a single dose. In addition , phototherapy is continued according to the standard protocol. Intervention 2: Control group: In this group , term neonates with prolonged unconjugated hyperbilirubinemia receive phototherapy according to standard protocol , with no additional medication. 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 Since this study is part of a student thesis and no final decision has been made regarding the publication of individual participant data (IPD), there is currently no plan for data sharing. If a related article is published in the future, data sharing may be considered in accordance with ethical principles.
public Ahmadreza Heidarynezhad
Ashoura street , Ghaem street , Banghalan
Ilam Iran (Islamic Republic of) 6939155585 +98 84 3225 1569 ahmadrezaheidarynezhad12@gmail.com Ilam University of Medical Sciences scientific Jasem Mohammadi
Ilam University of medaical sciences campus , Pazhuhesh Blvd , Banganjab
Ilam Iran (Islamic Republic of) 6939177143 +98 84 3222 7134 jmohamadi@medilam.ac.ir Ilam University of Medical Sciences Iran (Islamic Republic of) The neonate is full-term with gestational age between 37 and 42 weeks Jaundice persists beyond the 14th day of birth The neonate has no underlying pathological conditions such as Infection , Liver disorders , Hypothyroidism , Cholestasis , Hemolysis , G6PD deficiency , Blood group incompatibilities , metabolic disorders The neonate has normal birth weight Written informed consent is obtained from the parents 14 days 28 days Both The neonate has an active infection The neonate has liver disease , cholestasis or metabolic disorders The neonate has blood group incompatibility or G6PD deficiency The neonate has hypothyroidism The neonate is preterm (less than 37 weeks of gestation) The neonate has low birth weight ( Less than 2500 grams) Parents refuse to participate in the study Serum bilirubin level is high enough to require exchange transfusion P59.9 Neonatal jaundice, unspecified Treatment - Drugs Treatment - Other Intervention group: in this group , term neonates with prolonged Unconjugated Hyperbilirubinemia , recieves oral clofibrate at a dose of 50 mg/kg as a single dose. In addition , phototherapy is continued according to the standard protocol. Control group: In this group , term neonates with prolonged unconjugated hyperbilirubinemia receive phototherapy according to standard protocol , with no additional medication. Total serum bilirubin level in term neonates with prolonged indirect hyperbilirubinemia. Timepoint: Before the Intervention on day 1 , and on days 3 , 5 and 7 after the intervention. Method of measurement: At the beginning of the study, bilirubin levels will be measured using serum (blood) samples. In subsequent follow-ups, transcutaneous bilirubin will be used for monitoring to reduce invasiveness. However, if transcutaneous bilirubin levels are elevated or approach therapeutic thresholds, or if there is clinical discrepancy, serum measurements will be repeated to ensure data accuracy. Ilam University of Medical Sciences Approved 2024-02-14 Ethics comittee of Ilam University of Medical Sciences Ilam University of Medical Sciences Campus , Pazhuhesh Blvd , Banganjab Ilam Ilam Iran (Islamic Republic of)