Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Neonatal Jaundice.

NCT06346743 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB/2023/1119/SIMS
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Neonatal jaundice has significant importance in neonatal morbidity and mortality world-wide. Though phototherapy has a relentless use in neonatal jaundice, its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents. This study is conducted to observe the reduction of serum bilirubin level in neonates treated with Fenofibrate as an adjuvant to phototherapy in treatment of exaggerated physiological hyperbilirubinemia. After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted and later on, the data will be analyzed in the SPSS 26. Quantitative variables like age will be presented as mean ± SD. Qualitative variables like gender will be presented as percentage and frequency. Comparison of two groups intervention group and non-intervention group, apply independent sample t-test. P value \< 0.05 will be taken as significant. Limitation of the proposed study includes limited sample size, study population limited to only one hospital and no follow-up in plan. If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns, it will be beneficial to minimize the risk of the complications, rapid regression of hyperbilirubinemia \& shortening the length of hospital stay.

Conditions

Physiological Neonatal Jaundice; Physiological Hyperbilirubinaemia

Keywords

Phototherapy; Fenofibrate; Hyperbilirubinaemia; Neonatal Jaundice; Fenofibrate Adjuvant Phototherapy

Outcome Measures

Primary Outcomes (1)

• number of days needed for serum bilirubin to decrease below phototherapy range

  number of days needed for serum bilirubin to decrease below phototherapy range in both groups

  72 hours

Secondary Outcomes (1)

• Hospital length of Stay

  72 hours

Study Arms (2)

Fenofibrate adjuvant therapy

EXPERIMENTAL

Single dose fenofibrate adjuvant to conventional phototherapy

Drug: Fenofibrate; Device: Phototherapy

Conventional phototherapy

ACTIVE COMPARATOR

Only conventional phototherapy

Device: Phototherapy

Interventions

Fenofibrate DRUG

Single dose of Fenofibrate will be given at dose of 10mg/Kg along with phototherapy for 24 hours before next blood sampling

Also known as: Fenofibrate adjuvant phototerapy

Fenofibrate adjuvant therapy

Phototherapy DEVICE

only phototherapy will be given for 24 hours before next blood sampling

Also known as: conventional bluelight phototherapy

Conventional phototherapy; Fenofibrate adjuvant therapy

Eligibility Criteria

• Age: 24 Hours - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborn of either sex of age 2nd day of life to 14th day of life.
• Exaggerated physiological jaundice without identifiable cause.
• Full-term newborn ≥37 to ≤42 weeks of gestation with birth weight \>2.5kg
• Total serum bilirubin level within phototherapy range (NICE Guidelines)

You may not qualify if:

• Preterm newborn \< 37 weeks of gestation or low birth weight \<2.5kg
• Direct hyperbilirubinemia (Conjugated Bilirubin \>2mg/dl or \>10% of Total Serum Bilirubin)
• Pathological jaundice due to lab proven Sepsis / Blood Group Incompatibility.

Sponsors & Collaborators

• Muhammad Zark: lead

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Awad MH, Amer S, Hafez M, Nour I, Shabaan A. "Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.". J Perinatol. 2021 Apr;41(4):865-872. doi: 10.1038/s41372-020-00861-2. Epub 2020 Oct 17.

  PMID: 33070152 BACKGROUND

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia

Interventions

Fenofibrate; Phototherapy

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 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; Therapeutics

Study Officials

• Tayyaba K Butt, FCPS, MRCPCH

  Professor & Head of Department of Pediatrics

  STUDY CHAIR

Central Study Contacts

Muhammmad Zark, MBBS

CONTACT

+923038152088; zarkmughal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate Resident

Model Details: To compare the effects of Fenofibrate adjuvant to phototherapy with conventional phototherapy for exaggerated neonatal hyperbilirubinemia in the form of bilirubin reduction, duration of phototherapy, hospital stay \& observation of side-effects. After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: open

Locations

PA (1)