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

Effect of single dose Fenofibrate as an adjunct to Phototherapy Vs Phototherapy alone in Unconjugated Neonatal Hyperbilirubinemia-A Randomnised Control Trial.Monitor the ADR carefully and if any ADR happens treat them free of cost.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050811

Enrollment

Registered

2023-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P599- Neonatal jaundice, unspecified

Interventions

Intervention1: Single dose of fenofibrate along with phototherapy: 10/mg/kg orally Control Intervention1: Fenofibrate (10 mg/kg single dose) along with phototherapy: phototherapy alone Control Interve

Eligibility

Inclusion criteria

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

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 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDEEPAA S

Government Kilpauk medical college and hospital

sridevianaaraayan@gmail.com9884279417

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026