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A Comparative Study Of The Effect Of Clofibrate And Ursobil In Reducing Phototherapy Time For Neonatal Jaundice

Protocol summary

Study aim
To Compare the Effectiveness of Clofibrate and Ursobil in Reducing the Duration of Phototherapy and Total Serum Bilirubin Levels in Term Neonates With Unconjugated Hyperbilirubinemia.
Design
A Phase 3, Single Blind, Randomized, Two Arm Parallel Group Clinical Trial in 70 Term Neonates With Unconjugated Hyperbilirubinemia. Participants Will Be Randomized in a 1:1 Allocation Ratio Using Balanced Block Randomization.
Settings and conduct
This Study Will Be Conducted in the Neonatal Ward of Imam Khomeini Hospital, Ilam, Iran. Eligible Neonates Will Be Randomly Allocated to Two Intervention Groups After Obtaining Informed Consent From Their Parents. All Neonates Will Receive Standard Phototherapy and Will Be Followed Until Discharge and 48 Hours After Discharge.
Participants/Inclusion and exclusion criteria
Term Neonates (37–42 Weeks); Birth Weight 2500–4000 g; Age 2–10 Days; Non-Hemolytic Unconjugated Hyperbilirubinemia; Exclusively Breastfed; Candidate For Phototherapy Per AAP Guidelines. Prior Medication Or Phototherapy Before Enrollment; Major Congenital Anomaly; Underlying Maternal Or Neonatal Disease; Parental Refusal To Participate.
Intervention groups
Intervention Group 1: Phototherapy With Ursobil (UDCA) 15 Mg/kg/day, Orally In Two Doses Every 12 Hours; 300-Mg Capsule, Dr. Abidi, Tehran, Iran, Dissolved In Water. Continued From The Start Of Phototherapy Until Total Bilirubin Is Less Than 10 Mg/dL And Phototherapy Is Discontinued. Intervention Group 2: Phototherapy With Clofibrate 30 Mg/kg, Single Oral Dose, Zahravi, Tabriz, Iran. Continued From The Start Of Phototherapy Until Total Bilirubin Is Less Than 10 Mg/dL And Phototherapy Is Discontinued. Phototherapy Is Identical In Both Groups According To The AAP Protocol.
Main outcome variables
Duration of Phototherapy Until It Decreases to Below 10 mg/dL.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260718070242N1
Registration date: 2026-08-31, 1405/06/09
Registration timing: registered_while_recruiting

Last update: 2026-08-31, 1405/06/09
Update count: 0
Registration date
2026-08-31, 1405/06/09
Registrant information
Name
Hajar Ansari Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 0948
Email address
hajar.ansari7984@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-06, 1405/05/15
Expected recruitment end date
2026-11-06, 1405/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study Of The Effect Of Clofibrate And Ursobil In Reducing Phototherapy Time For Neonatal Jaundice
Public title
Effect Of Clofibrate And Ursobil On Reducing Phototherapy Duration In Neonatal Jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 2 days old to 10 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Ilam University of Medical Sciences Campus, Pazhohesh Boulevard, Bangenjab, Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2026-06-23, 1405/04/02
Ethics committee reference number
IR.MEDILAM.REC.1405.071

Health conditions studied

1

Description of health condition studied
Neonatal Unconjugated Hyperbilirubinemia
ICD-10 code
P59.8
ICD-10 code description
Neonatal jaundice from other specified causes

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
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.

2

Description
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

3

Description
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.

4

Description
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.

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Neonatal Ward, Imam Khomeini Hospital, Ilam, Iran
Full name of responsible person
Sajad Nourollahi
Street address
Imam Khomeini Hospital, Before Shahid Morteza Sadeh-Miri St., Ayatollah Heydari St., Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 8255
Email
emamkhominihospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Jamil Sadeghifar
Street address
Research and Technology Deputy, Ilam University of Medical Sciences Campus, Pazhouhesh Blvd., Banganjab, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7140
Email
vcr@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Hajar Ansari Mehr
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alghadir Dormitory, Near Telecommunication Square, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
۶۹۳۱۱۴۴۶۹۰
Phone
+98 71 3635 0948
Fax
Email
hajar.ansari7984@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Hajar Ansari Mehr
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alghadir Dormitory, Near Telecommunication Square, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
۶۹۳۱۱۴۴۶۹۰
Phone
+98 71 3635 0948
Fax
Email
hajar.ansari7984@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Hajar Ansari Mehr
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alghadir Dormitory, Near Telecommunication Square, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
۶۹۳۱۱۴۴۶۹۰
Phone
+98 71 3635 0948
Fax
Email
hajar.ansari7984@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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