A Phase 4 interventional study of Fenofibrate + Phototherapy and Phenobarbitone + Phototherapy in Jaundice, Neonatal, sponsored by Rubab Fatima. Not yet recruiting. Open to participants aged 24 Hours to 14 Days. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Rubab Fatima · Phase 4, Interventional, and Treatment
This is a prospective, randomized, open-label controlled trial comparing fenofibrate (10 mg/kg) and phenobarbitone (3 mg/kg) as adjuncts to conventional phototherapy in neonates with unconjugated hyperbilirubinemia. The study aims to compare their effectiveness in reducing total serum bilirubin. Secondary outcomes include duration of phototherapy, length of hospital stay, and treatment-related adverse effects.
Neonatal hyperbilirubinemia is one of the most common conditions requiring medical attention during the neonatal period. Although phototherapy is the standard treatment for uncomplicated indirect hyperbilirubinemia, adjuvant pharmacological therapies may enhance bilirubin clearance and reduce the duration of phototherapy and hospital stay.
Fenofibrate induces hepatic enzymes involved in bilirubin conjugation and excretion, whereas phenobarbitone has traditionally been used to increase bilirubin metabolism through enzyme induction. The comparative effectiveness of these two agents as adjuncts to phototherapy has not been adequately evaluated.
This Phase IV, prospective, randomized, open-label, parallel-group clinical trial aims to compare the efficacy and safety of fenofibrate versus phenobarbitone as adjuncts to conventional phototherapy in neonates with indirect hyperbilirubinemia.
Eligible neonates will be randomly assigned in a 1:1 ratio to receive either fenofibrate plus phototherapy or phenobarbitone plus phototherapy. The primary outcome is the reduction in total serum bilirubin. Secondary outcomes include the duration of phototherapy, length of hospital stay, need for exchange transfusion (if applicable), and the occurrence of adverse events. Participants will be followed until resolution of hyperbilirubinemia and discharge according to the study protocol.
The results of this study are expected to provide evidence regarding the more effective adjunctive therapy for the management of neonatal indirect hyperbilirubinemia.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 70 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →This is the only study on the registry with Rubab Fatima as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In Group A, 35 neonates will receive fenofibrate 10 mg/kg + phototherapy
Drug: Fenofibrate + Phototherapy
In Group B 35 neonates will receive phenobarbitone 3 mg/kg, in addition to phototherapy
Drug: Phenobarbitone + Phototherapy
Drug page: Fenofibrate
Participants randomized to the experimental group will receive a single oral dose of fenofibrate in addition to standard phototherapy. Phototherapy will be administered according to the hospital's neonatal jaundice management protocol. Clinical assessment and serial total serum bilirubin measurements will be performed as per the study protocol until the infant meets the criteria for discontinuation of phototherapy and discharge.
Drug page: Phenobarbital
Participants randomized to the active comparator group will receive oral phenobarbitone in addition to standard phototherapy. Phototherapy will be administered according to the hospital's neonatal jaundice management protocol. Clinical assessment and serial total serum bilirubin measurements will be performed as per the study protocol until the infant meets the criteria for discontinuation of phototherapy and discharge.
Change in total serum bilirubin (TSB)
Change in total serum bilirubin (TSB) level during treatment (serial measurements and comparison between groups).
Time frame: Baseline and at 48 hours after initiation of treatment
Duration of phototherapy
Duration of phototherapy given to neonates
Time frame: From initiation untill discontinuation of phototherapy during index hospitalization(approximately upto 72 hours)
Duration of Hospital Stay
Date of admission of neonate till its discharge date will be calculated as the hospital stay of neonate
Time frame: From hospital admission untill hospital discharge during index hospitalization(approximatley upto 5 days)
Safety profile (adverse effects) including: Skin rash, Dehydration, Gastrointestinal symptoms, Hepatotoxicity, Renal impairment, Hypoglycemia, Sedation
Assessment of the safety of fenofibrate and phenobarbitone by monitoring the incidence of treatment-related adverse events, including skin rash, dehydration, gastrointestinal symptoms, hepatotoxicity, renal impairment, hypoglycemia, and sedation during the study period.
Time frame: Baseline and through 48 hours after initiation of treatment
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fenofibrate