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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250722066600N1
Enrollment
120
Registered
2025-08-18
Start date
2024-09-22
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged Indirect Hyperbilirubinemia in Term Neonates. Neonatal jaundice, unspecified

Interventions

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 , photot

Sponsors

Ilam University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Days to 28 Days

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmadreza Heidarynezhad

Ilam University of Medical Sciences

ahmadrezaheidarynezhad12@gmail.com+98 84 3225 1569

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026