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

NCT04868019 | Unknown DMC

• 1 other identifier: No.F.1-1/2015/ERB/SZABMU/654
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serum bilirubin level

  6 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: Fenofibrate Capsules

Group B

PLACEBO COMPARATOR

Group B will receive solution B i.e placebo.

Drug: Fenofibrate Capsules

Interventions

Fenofibrate Capsules 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

Also known as: capsule fenoget

Group A; Group B

Eligibility Criteria

• Age: 2 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≥ 35 weeks
• Birth weight ≥ 2 kg
• Age: 2-7 days of life
• Total serum bilirubin level ≥15mg/dl and ≤20 mg/dl

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share