Can a single dose of fenofibrate beat phenobarbitone for newborn jaundice?
NCT ID NCT07774741
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial tests whether adding a single dose of fenofibrate or phenobarbitone to standard light therapy (phototherapy) can lower bilirubin levels faster in newborns with jaundice. The study includes full-term babies with moderate jaundice who need phototherapy. Researchers will compare how quickly bilirubin drops, how long phototherapy and hospital stays last, and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fenofibrate or phenobarbitone, given as a single oral dose alongside standard phototherapy
- What this could lead to
- If fenofibrate works better than phenobarbitone, it could shorten phototherapy time and hospital stays for newborns with jaundice.
- What could go wrong
- This is a small, early-stage comparison, and results may not apply to all newborns. Both drugs can have side effects, and fenofibrate's safety in neonates is not fully established.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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24 hours to 14 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Term neonates aged 24 hours to 14 days with gestational age 37-42 weeks. * Birth weight ≥2500 g. * Physiological, non-haemolytic indirect hyperbilirubinemia with total serum bilirubin 15-20 mg/dL, requiring phototherapy according to age-specific guidelines. * Written informed consent from parents or legal guardian. Exclusion Criteria: * Preterm or low-birth-weight neonates. * Jaundice appearing within the first 24 hours of life. * ABO or Rh incompatibility, positive direct Coombs test, or any evidence of haemolysis. * Neonates with sepsis, birth asphyxia, shock, congenital anomalies, cholestasis, liver or renal disease. * Neonates with electrolyte, acid-base, coagulation, or intrauterine infection-related disorders. * Previous neonatal use of fenofibrate or phenobarbitone, or maternal phenobarbitone use during pregnancy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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