[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652492":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":41,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":26,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":26},{"fullName":5,"class":6},"Sheikh Zayed Medical College","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: fenofibrate + phototherapy","EXPERIMENTAL","In Group A, 35 neonates will receive fenofibrate 10 mg\u002Fkg + phototherapy",[13],"Drug: Fenofibrate + Phototherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: Phenobarbitone + phototherapy","ACTIVE_COMPARATOR","In Group B 35 neonates will receive phenobarbitone 3 mg\u002Fkg, in addition to phototherapy",[19],"Drug: Phenobarbitone + Phototherapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fenofibrate + Phototherapy","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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Phenobarbitone + Phototherapy","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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Rubab Fatima Postgradue Trainee, MBBS","CONTACT","03207051700","rubab.fatima.raffay26@gmail.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Rubab Fatima","Sheikh Zayed Medical College, Rahim yar Khan.",[42],{"name":5,"class":6},"100652492","phase-4-comparison-of-fenofibrate-vs-phenobarbitone-as-adjunct-to-phototherapy-in-reducing-total-serum-bilirubin-in-indirect-hyperbilirubinemia-in-neonates-100652492",false,"NCT07774741","Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates","Inclusion Criteria:\n\n* Term neonates aged 24 hours to 14 days with gestational age 37-42 weeks.\n* Birth weight ≥2500 g.\n* Physiological, non-haemolytic indirect hyperbilirubinemia with total serum bilirubin 15-20 mg\u002FdL, requiring phototherapy according to age-specific guidelines.\n* Written informed consent from parents or legal guardian.\n\nExclusion Criteria:\n\n* Preterm or low-birth-weight neonates.\n* Jaundice appearing within the first 24 hours of life.\n* ABO or Rh incompatibility, positive direct Coombs test, or any evidence of haemolysis.\n* Neonates with sepsis, birth asphyxia, shock, congenital anomalies, cholestasis, liver or renal disease.\n* Neonates with electrolyte, acid-base, coagulation, or intrauterine infection-related disorders.\n* Previous neonatal use of fenofibrate or phenobarbitone, or maternal phenobarbitone use during pregnancy.","ALL","24 Hours","14 Days",{"count":53,"type":54},70,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","This is a prospective, randomized, open-label controlled trial comparing fenofibrate (10 mg\u002Fkg) and phenobarbitone (3 mg\u002Fkg) 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.",[60],"Jaundice, Neonatal",[62,63,64],"indirect hyperbilirubinemia","fenofibrate+phototherapy","phenobarbitone+phototherapy","NOT_YET_RECRUITING","2026-08-17",{"date":68,"type":69},"2026-08-19","ACTUAL",{"date":71,"type":54},"2026-10",{"date":73,"type":54},"2027-10",{"name":39,"class":6}]