Jaundice, NeonatalPhase 4NCT07774741
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
A Phase 4 study testing Fenofibrate + Phototherapy and Phenobarbitone + Phototherapy in people with Jaundice, Neonatal, run by Rubab Fatima.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 hours to 14 days
- Conditions the study is for
- Jaundice, Neonatal
- What is being tested?
- Fenofibrate + Phototherapy and Phenobarbitone + Phototherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Jaundice, Neonatal
- Being tested
- Fenofibrate + Phototherapy, Phenobarbitone + Phototherapy
- Keywords
- indirect hyperbilirubinemia, fenofibrate+phototherapy, phenobarbitone+phototherapy
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate + PhototherapyDrug
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.
Phenobarbitone + PhototherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: fenofibrate + phototherapy | Experimental | In Group A, 35 neonates will receive fenofibrate 10 mg/kg + phototherapy Receives: Drug: Fenofibrate + Phototherapy |
| Group B: Phenobarbitone + phototherapy | Active comparator | In Group B 35 neonates will receive phenobarbitone 3 mg/kg, in addition to phototherapy Receives: Drug: Phenobarbitone + Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total serum bilirubin (TSB)
Change in total serum bilirubin (TSB) level during treatment (serial measurements and comparison between groups).
Measured: Baseline and at 48 hours after initiation of treatment
Secondary outcomes (3)
Duration of phototherapy
Duration of phototherapy given to neonates
Measured: 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
Measured: 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.
Measured: Baseline and through 48 hours after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, having sample size of 70 patients, eligible neonates will be recruited through non-probability consecutive sampling and randomly allocated in a 1:1 ratio to Group A or Group B using the lottery method.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rubab Fatima
- Sponsor type
- Other government
- Collaborators
- Sheikh Zayed Medical College
- Responsible party
- Sponsor-investigator, Rubab Fatima, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774741
- Sponsor's protocol ID
- SZMC-MPE-2026-003-009-005-0001
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdellatif M, Abozaid AAF, Shah PS, Dhouibi N, Nguyen-Khac T, Khleif R, Luu MN, Quyen DK, Mohareb A, Vaghela G, Khan ZA, Pham HN, Makram AM, Huy NT. Efficacy and safety of fenofibrate in combination with phototherapy for the treatment of neonatal hyperbilirubinemia: a systematic review and meta-analyses. Can J Physiol Pharmacol. 2024 Apr 1;102(4):242-253. doi: 10.1139/cjpp-2023-0213. Epub 2023 Nov 27.
PubMed 38011686
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
- ClinicalTrials.gov ID
- NCT07774741
- Acronym / sponsor ID
- SZMC-MPE-2026-003-009-005-0001
- Conditions
- Jaundice, Neonatal
- Keywords
- indirect hyperbilirubinemia, fenofibrate+phototherapy, phenobarbitone+phototherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rubab FatimaOther government
- Collaborators
- Sheikh Zayed Medical College
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial, having sample size of 70 patients, eligible neonates will be recruited through non-probability consecutive sampling and randomly allocated in a 1:1 ratio to Group A or Group B using the lottery method.
| Arm | Type | Receives |
|---|---|---|
| Group A: fenofibrate + phototherapy | Experimental | Drug: Fenofibrate + PhototherapyIn Group A, 35 neonates will receive fenofibrate 10 mg/kg + phototherapy |
| Group B: Phenobarbitone + phototherapy | Active comparator | Drug: Phenobarbitone + PhototherapyIn Group B 35 neonates will receive phenobarbitone 3 mg/kg, in addition to phototherapy |
Who may qualify
- Ages
- 24 hours to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate + PhototherapyParticipants 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 | Group A: fenofibrate + phototherapy |
| Phenobarbitone + PhototherapyParticipants 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. | Drug | Group B: Phenobarbitone + phototherapy |
Primary outcome
Change in total serum bilirubin (TSB)
Time frame: Baseline and at 48 hours after initiation of treatment
Change in total serum bilirubin (TSB) level during treatment (serial measurements and comparison between groups).
3 secondary outcomes
Duration of phototherapy
Time frame: From initiation untill discontinuation of phototherapy during index hospitalization(approximately upto 72 hours)
Duration of Hospital Stay
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
Time frame: Baseline and through 48 hours after initiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 38011686Abdellatif M, Abozaid AAF, Shah PS, Dhouibi N, Nguyen-Khac T, Khleif R, Luu MN, Quyen DK, Mohareb A, Vaghela G, Khan ZA, Pham HN, Makram AM, Huy NT. Efficacy and safety of fenofibrate in combination with phototherapy for the treatment of neonatal hyperbilirubinemia: a systematic review and meta-analyses. Can J Physiol Pharmacol. 2024 Apr 1;102(4):242-253. doi: 10.1139/cjpp-2023-0213. Epub 2023 Nov 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenofibrate + Phototherapy and Phenobarbitone + Phototherapy in people with Jaundice, Neonatal, run by Rubab Fatima.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubab Fatima Postgradue Trainee, MBBS (03207051700, rubab.fatima.raffay26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total serum bilirubin (TSB) (time frame: Baseline and at 48 hours after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07774741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.