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

Shaheed Zulfiqar Ali Bhutto Medical University

Status: Unknown

Conditions: Hyperbilirubinemia, Neonatal

Treatments: Drug: Fenofibrate Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04868019

No.F.1-1/2015/ERB/SZABMU/654

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

Groups A will receive solution A .i.e fenofibrate suspension

Treatment:

Drug: Fenofibrate Capsules

Group B

Placebo Comparator group

Description:

Group B will receive solution B i.e placebo.

Treatment:

Drug: Fenofibrate Capsules