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IRCT20260718070242N1 IRCT 2026-08-31 Ilam University of Medical Sciences Effect Of Clofibrate And Ursobil On Reducing Phototherapy Duration In Neonatal Jaundice A Comparative Study Of The Effect Of Clofibrate And Ursobil In Reducing Phototherapy Time For Neonatal Jaundice 2026-08-06 anticipated 70 Complete https://irct.ir/trial/91750 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible Participants Will Be Randomly Allocated After Obtaining Informed Consent to Two Study Groups, the Ursobil Group and the Clofibrate Group, Using Balanced Block Randomization With a Block Size of 4 and a 1:1 Allocation Ratio. The Randomization Unit Will Be Each Neonate. The Randomization Sequence Will Be Generated Using Microsoft Excel, and Participants Will Be Allocated According to the Pre Generated Randomization Sequence, Blinding description: This Study Will Be Conducted as a Single Blind Trial. After Obtaining Informed Consent, the Parents Will Be Informed About Their Neonate’s Participation in the Study and the Existence of Two Treatment Groups, Ursobil and Clofibrate, but They Will Not Be Informed of Their Neonate’s Allocation to Either Treatment Group. The Assigned Intervention Will Be Administered to the Neonate by the Healthcare Personnel Responsible for Medication Administration, and the Treatment Group Will Not Be Disclosed to the Parents. The Researcher, Treating Physician, and Healthcare Personnel Will Be Aware of the Group Allocation. 3 Neonatal Unconjugated Hyperbilirubinemia. Intervention 1: Intervention Group 1: Ursodeoxycholic Acid (UDCA) Will Be Administered Orally At A Dose Of 15 Mg/kg/day, Divided Into Two Equal Doses Every 12 Hours. Ursobil Is Available As 300-Mg Capsules Manufactured By Dr. Abidi Pharmaceutical Company, Tehran, Iran. The Capsule Will Be Dissolved In Water And Administered Orally To The Neonate. Ursobil Will Be Administered From The Initiation Of Phototherapy Until The Discontinuation Of Phototherapy. Phototherapy And Ursobil Administration Will Be Discontinued When The Total Serum Bilirubin Level Reaches Less Than 10 Mg/dL. Intervention 2: Intervention Group 2: Clofibrate At A Dose Of 30 Mg/kg Will Be Administered As A Single Oral Dose. The Clofibrate Is Manufactured By Zahravi Pharmaceutical Company, Tabriz, Iran, With Batch Number 218 And Registration Number 1228098598. Clofibrate Will Be Administered From The Initiation Of Phototherapy Until The Discontinuation Of Phototherapy. Phototherapy And Clofibrate Administration Will Be Discontinued When The Total Serum Bilirubin Level Reaches Less Than 10 Mg/dL. 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 The Trial Is Ongoing. Individual Participant Data Will Not Be Shared Until the Study Is Completed, the Final Analyses Are Performed, and the Main Results Are Published. Any Future Data Sharing Will Be Considered After Completion of the Study in Accordance With Institutional Policies.
public Hajar Ansari Mehr
Alghadir Dormitory, Near Telecommunication Square, Ilam, Iran
Ilam Iran (Islamic Republic of) ۶۹۳۱۱۴۴۶۹۰ +98 71 3635 0948 hajar.ansari7984@gmail.com Ilam University of Medical Sciences scientific Hajar Ansari Mehr
Alghadir Dormitory, Near Telecommunication Square, Ilam, Iran
Ilam Iran (Islamic Republic of) ۶۹۳۱۱۴۴۶۹۰ +98 71 3635 0948 hajar.ansari7984@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Term Neonates With Gestational Age of 37 to 42 Weeks Birth Weight Between 2500 and 4000 g Age 2 to 10 Days Non-Hemolytic Unconjugated Hyperbilirubinemia Exclusive Breastfeeding Candidates for Phototherapy According to the American Academy of Pediatrics (AAP) Guideline 2 days 10 days Both Previous Use of Medications Affecting Neonatal Jaundice Before Study Entry Previous Phototherapy Before Study Entry Presence of a Major Congenital Anomaly Lack of Parental Consent to Participate in the Study Presence of Maternal Diseases, Such as Eclampsia, Diabetes, Chorioamnionitis, or Gestational Hypertension. P59.8 Neonatal jaundice from other specified causes Treatment - Drugs Treatment - Drugs Intervention Group 1: Ursodeoxycholic Acid (UDCA) Will Be Administered Orally At A Dose Of 15 Mg/kg/day, Divided Into Two Equal Doses Every 12 Hours. Ursobil Is Available As 300-Mg Capsules Manufactured By Dr. Abidi Pharmaceutical Company, Tehran, Iran. The Capsule Will Be Dissolved In Water And Administered Orally To The Neonate. Ursobil Will Be Administered From The Initiation Of Phototherapy Until The Discontinuation Of Phototherapy. Phototherapy And Ursobil Administration Will Be Discontinued When The Total Serum Bilirubin Level Reaches Less Than 10 Mg/dL. Intervention Group 2: Clofibrate At A Dose Of 30 Mg/kg Will Be Administered As A Single Oral Dose. The Clofibrate Is Manufactured By Zahravi Pharmaceutical Company, Tabriz, Iran, With Batch Number 218 And Registration Number 1228098598. Clofibrate Will Be Administered From The Initiation Of Phototherapy Until The Discontinuation Of Phototherapy. Phototherapy And Clofibrate Administration Will Be Discontinued When The Total Serum Bilirubin Level Reaches Less Than 10 Mg/dL. Duration of Phototherapy Until Total Serum Bilirubin Decreases to Less Than 10 mg/dL (Hours). Timepoint: From the Initiation of Phototherapy Until Discontinuation of Phototherapy During Hospitalization. Method of measurement: The Duration of Phototherapy Will Be Recorded in Hours From the Initiation of Phototherapy Until Its Discontinuation (When Total Serum Bilirubin Falls Below 10 mg/dL). Total Serum Bilirubin Will Be Measured Using the DCA Method (Prestige 24i, Japan) in the Laboratory of Imam Khomeini Hospital, Ilam. Total Serum Bilirubin Level. Timepoint: Before Initiation of the Intervention and at 24, 48, and 72 Hours After Initiation of the Intervention. Method of measurement: Total Serum Bilirubin Will Be Measured Using the DCA Method (Prestige 24i, Japan) and Recorded in mg/dL. Length of Hospital Stay. Timepoint: At Hospital Discharge. Method of measurement: The Duration of Hospital Stay From Admission to Discharge Will Be Recorded in Days From the Medical Record. Recurrence of Neonatal Jaundice After Discharge. Timepoint: After Completion of the Intervention and 48 Hours After Discharge From the Hospital. Method of measurement: Recurrence of Jaundice Will Be Evaluated at the 48-Hour Follow-Up Visit Based on Clinical Examination and, If Required, Total Serum Bilirubin Measurement. Short-Term Adverse Effects of the Intervention. Timepoint: During the Intervention Until Discharge and 48 Hours After Discharge From the Hospital. Method of measurement: Adverse Effects Will Be Assessed Through Clinical Examination, Review of Medical Records, and Recording in a Researcher-Designed Checklist. Ilam University of Medical Sciences Approved 2026-06-23 Ethics committee of Ilam University of Medical Sciences Vice Chancellor for Research and Technology, Ilam University of Medical Sciences Campus, Pazhohesh Boulevard, Bangenjab, Ilam Ilam Ilam Iran (Islamic Republic of)