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

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

Fenofibrate in Indirect Neonatal Hyperbilirubinemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04868019
• Other study ID #: No.F.1-1/2015/ERB/SZABMU/654
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: February 2022

Study information

• Verified date: August 2021
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum bilirubin level	It will be measured at the time of admission and then at 12hr, 24hr, and 48 hours of treatment.	6 months