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

NCT ID: NCT04868019

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-02-28

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.

Conditions

Hyperbilirubinemia, Neonatal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Fenofibrate Capsules

Intervention Type: DRUG

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

Group B

Group B will receive solution B i.e placebo.

Group Type: PLACEBO_COMPARATOR

Fenofibrate Capsules

Intervention Type: DRUG

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

Interventions

Fenofibrate Capsules

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

Intervention Type: DRUG

Other Intervention Names

capsule fenoget

Eligibility Criteria

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

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dr Nighat Haider

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id