protocolSection identificationModule nctId: NCT06346743, orgStudyIdInfo id: IRB/2023/1119/SIMS, briefTitle: Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Neonatal Jaundice., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Muhammad Zark, class: OTHER_GOV, descriptionModule briefSummary: Neonatal jaundice has significant importance in neonatal morbidity and mortality world-wide. Though phototherapy has a relentless use in neonatal jaundice, its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents. This study is conducted to observe the reduction of serum bilirubin level in neonates treated with Fenofibrate as an adjuvant to phototherapy in treatment of exaggerated physiological hyperbilirubinemia. After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted and later on, the data will be analyzed in the SPSS 26. Quantitative variables like age will be presented as mean ± SD. Qualitative variables like gender will be presented as percentage and frequency. Comparison of two groups intervention group and non-intervention group, apply independent sample t-test. P value \< 0.05 will be taken as significant. Limitation of the proposed study includes limited sample size, study population limited to only one hospital and no follow-up in plan. If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns, it will be beneficial to minimize the risk of the complications, rapid regression of hyperbilirubinemia \& shortening the length of hospital stay., conditionsModule conditions: Physiological Neonatal Jaundice, conditions: Physiological Hyperbilirubinaemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To compare the effects of Fenofibrate adjuvant to phototherapy with conventional phototherapy for exaggerated neonatal hyperbilirubinemia in the form of bilirubin reduction, duration of phototherapy, hospital stay \& observation of side-effects.After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Fenofibrate, interventions name: Phototherapy, outcomesModule primaryOutcomes measure: number of days needed for serum bilirubin to decrease below phototherapy range, secondaryOutcomes measure: Hospital length of Stay, eligibilityModule sex: ALL, minimumAge: 24 Hours, maximumAge: 14 Days, stdAges: CHILD, contactsLocationsModule locations facility: Services Institute of Medical Sciences, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, contacts name: Noman Abdullah, role: CONTACT, phone: +923124100143, email: info@sims.edu.pk, contacts name: Muhammad Zark, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.558, lon: 74.35071, hasResults: False