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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fenofibrate in Indirect Neonatal Hyperbilirubinemia

Conditions
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Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Drug: Fenofibrate Capsules


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Gestational age ≥ 35 weeks Birth weight ≥ 2 kg Age: 2-7 days of life Total serum bilirubin level ≥15mg/dl and ≤20 mg/dl EXCLUSION CRITERIA: Neonates with total bilirubin >20mg/dl Conjugated bilirubin level greater than 15% of total serum bilirubin Maternal hyperbilirubinemia (on medical record) Babies with congenital anomalies (on clinical examination) Those not consenting to participate in the study

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Groups A will receive solution A .i.e fenofibrate suspension | Drug: Fenofibrate Capsules<br>* Solutions will be prepared in the required strengths and labeled accordingly. Group 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<br>* Other names: capsule fenoget;|
| Placebo Comparator: Group B<br>Group B will receive solution B i.e placebo. | Drug: Fenofibrate Capsules<br>* Solutions will be prepared in the required strengths and labeled accordingly. Group 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<br>* Other names: capsule fenoget;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of phototherapy | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum bilirubin level | It will be measured at the time of admission and then at 12hr, 24hr, and 48 hours of treatment. | 6 months |