Role of Fenofibrate in Indirect Neonatal Hyperbilirubinemia: a Randomized Control Trial

Not Applicable

• Conditions: Hyperbilirubinemia, Neonatal
• Interventions: Drug: Fenofibrate Capsules

• Registration Number: NCT04868019
• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Brief Summary

Fenofibrate accelerates bilirubin conjugation and excretion, decreasing the side effects of prolonged unconjugated hyperbilirubinemia in neonates. It also reduces the duration of phototherapy and thus the duration of stay in the hospital. This research is carried out to improve standard protocol for the management of neonatal hyperbilirubinemia in the local settings.

Detailed Description

Complete history and examination will be carried out while patients will be screened for enrollment. After taking informed consent, eligible patients will be selected and divided into two groups A and B by lottery method. Demographics like name, age (hours), gender, birth weight, and gestational age will be noted. Solutions will be prepared in the required strengths and labeled accordingly. Groups A will receive Solution A i.e. Fenofibrate suspension is prepared by dissolving 200 mg capsule in 10 ml distilled water and given as a single dose of 10mg/kg (0.5 ml/kg) and Group B will receive solution B i.e. 0.5ml/ kg normal saline as a placebo. Both groups will receive LED phototherapy under standard conditions. The serum bilirubin level will be noted at the time of admission and then at 12hr, 24hr, and 48 hours of treatment. All this information will be recorded on proforma.

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-04-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-22
• Last Update Posted: 2021-08-24
• Study Start: 2021-09
• Primary Completion: 2022-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Fenofibrate Capsules	Groups A will receive solution A .i.e fenofibrate suspension
Group B	Fenofibrate Capsules	Group B will receive solution B i.e placebo.

Primary Outcome Measures

Name	Time	Method
Duration of phototherapy	6 months	It is the total time from admission (Serum bilirubin level ≥15 and ≤20 mg/dl) until phototherapy is no longer needed (Serum bilirubin level \< 10mg/dl) and is measured in hours.

Secondary Outcome Measures

Name	Time	Method
Serum bilirubin level	6 months	It will be measured at the time of admission and then at 12hr, 24hr, and 48 hours of treatment.