A CLINICAL TRIAL ON EFFECT OF SINGLE DOSE FENOFIBRATE AS AN ADJUNCT TO PHOTOTHERAPY IN NEONATAL JAUNDICE

Phase 4

Completed

• Conditions: Health Condition 1: P599- Neonatal jaundice, unspecified

• Registration Number: CTRI/2023/03/050811
• Lead Sponsor: Deepaa S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 94

Inclusion Criteria

1.Unconjugated hyperbilirubinemia who needed phototherapy according to American Academy of Paediatric (AAP) criteria (phototherapy graph),

2.Term baby (with gestational age of >37 weeks to 42 weeks),

3.Exclusively breastfed,

4.Total serum bilirubin(TSB) levels above 15.0 to 21.0mg/dl,

5.Age >24 hours to 14 days,

6.Birth weight 2500 to 3999 grams.

Exclusion Criteria

1.Neonate with conjugated hyperbilirubinemia >2 mg/dl or >15% of TSB,

2.Hemolytic jaundice due to Rh or ABO incompatibility

3.Birth weight <2500 grams and gestational age <37 weeks,

4.G6PD deficiency or Hypothyroidism,

5.Congenital anomalies and structural anomalies of liver and kidney,

6.Very sick neonates with jaundice (suspected infections, dehydration, asphyxia, inborn errors of metabolism, coagulation disorders)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare if single dose of fenofibrate with phototherapy decreases the duration of phototherapy in neonatal hyperbilirubinemiaTimepoint: By measuring Serum bilirubin level below phototherapy range according to AAP phototherapy graph taken every 24 hours apart and calculating the duration of phototherapy in hours

Secondary Outcome Measures

Name	Time	Method
To compare if a single dose of fenofibrate with phototherapy increases the rate of fall of bilirubin more rapidly in neonatal hyperbilirubinemiaTimepoint: By measuring Serum bilirubin level below phototherapy range according to AAP phototherapy graph taken every 24 hours apart;To determine the side-effects associated with fenofibrateTimepoint: By measuring SGPT levels after 24 hours of giving single dose oral fenofibrate