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Evaluation of the therapeutic effect of clofibrate on reducing prolonged indirect hyperbilirubinemia in term neonates

Protocol summary

Study aim
To evaluate the therapeutic effect of clofibrate on reducing prolonged unconjugated hyperbilirubinemia in term neonates
Design
This is a phase 2–3 randomized clinical trial with two parallel groups. Participants were randomly assigned using a random number table to either the intervention group (clofibrate + phototherapy) or the control group (phototherapy only). Due to the clear difference in interventions, blinding of participants and implementers was not feasible; however, the data analyst was blinded to group allocation. The analysis will be based on the comparison of treatment efficacy.
Settings and conduct
The study will be conducted at the pediatric clinic of Imam Khomeini Hospital in Ilam
Participants/Inclusion and exclusion criteria
Participants are term neonates (gestational age 37–42 weeks) with birth weight over 2500 grams, presenting with prolonged unconjugated neonatal jaundice and clinically stable condition. Inclusion criteria: term neonate, normal birth weight, prolonged unconjugated jaundice, no underlying disease, no pathological jaundice, no active infection, and written informed consent from parents. Exclusion criteria: presence of underlying disease, pathological jaundice, active infection, prematurity, low birth weight, need for exchange transfusion at admission, or lack of parental consent to participate in the study.
Intervention groups
In the intervention group, in addition to receiving phototherapy based on the standard protocol, neonates will receive a single oral dose of clofibrate at 50 mg per kilogram of body weight. In the control group, neonates will receive only phototherapy according to the standard protocol.
Main outcome variables
Changes in total serum bilirubin levels measured on days 3 , 5 and 7 after intervention; The first measurment is performed using Blood sampling and subsequent measurments using a transcutaneous device

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250722066600N1
Registration date: 2025-08-18, 1404/05/27
Registration timing: registered_while_recruiting

Last update: 2025-08-18, 1404/05/27
Update count: 0
Registration date
2025-08-18, 1404/05/27
Registrant information
Name
Ahmadreza Heidarynezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
ahmadrezaheidarynezhad12@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of clofibrate on reducing prolonged indirect hyperbilirubinemia in term neonates
Public title
Studying the effect of clofibrate on reducing prolonged jaundice in newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 14 days old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences Campus , Pazhuhesh Blvd , Banganjab
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2024-02-14, 1402/11/25
Ethics committee reference number
IR.MEDILAM.REC.1402.253

Health conditions studied

1

Description of health condition studied
Prolonged Indirect Hyperbilirubinemia in Term Neonates
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified

Primary outcomes

1

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
Control group: In this group , term neonates with prolonged unconjugated hyperbilirubinemia receive phototherapy according to standard protocol , with no additional medication.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital , Ilam
Full name of responsible person
Jasem mohammadi
Street address
Imam Khomeini Hospital , Ayatollah Heidari street
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
emamkhominihospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Naser Abbasi
Street address
Ilam University of Medical Sciences campus , Pazhuhesh Blvd , Banganjab
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
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
Ahmadreza Heidarynezhad
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Medical student
Street address
Ashoura street , Ghaem street , Banghalan
City
Ilam
Province
Ilam
Postal code
6939155585
Phone
+98 84 3225 1569
Email
ahmadrezaheidarynezhad12@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Jasem Mohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ilam University of medaical sciences campus , Pazhuhesh Blvd , Banganjab
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
jmohamadi@medilam.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ahmadreza Heidarynezhad
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Medical student
Street address
Ashoura street , Ghaem street , Banghalan
City
Ilam
Province
Ilam
Postal code
6939155585
Phone
+98 84 3225 1569
Email
ahmadrezaheidarynezhad12@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Not applicable
Title and more details about the data/document
The study protocol, statistical analysis plan, and final clinical trial report after study completion will be shared upon formal request and approval by the Ethics Committee.
When the data will become available and for how long
The data will be available for 6 months after the publication of the article
To whom data/document is available
Qualified researchers, Faculty members, graduate students, and related professionals in related fields
Under which criteria data/document could be used
Only for research projects and academic publications, with proper citation and adherence to research ethics. Commercial use is not allowed.
From where data/document is obtainable
Requests can be directed to the corresponding author via the email registered in the IRCT system.
What processes are involved for a request to access data/document
After receiving a formal request, the research team will review the request, and upon approval, the requested documents will be sent via email.
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