[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555882":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":53,"centralContacts":65,"locations":75,"responsibleParty":93,"collaborators":97,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":12,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":12,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":78,"whyStopped":12,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Future University in Egypt","OTHER",[8,13,19,23,28,30,33,36],{"label":9,"type":10,"description":11,"interventionNames":12},"preterm: control","NO_INTERVENTION","phototherapy only",null,{"label":14,"type":15,"description":16,"interventionNames":17},"preterm: low dose of oral zinc sulfate","EXPERIMENTAL","Neonates will receive oral Zn sulfate solution in low doses (10 mg\u002Fday) given as 5 mg twice daily.",[18],"Drug: Zinc sulfate",{"label":20,"type":15,"description":21,"interventionNames":22},"preterm: high dose of oral zinc sulfate","Neonates will receive oral Zn sulfate solution in a high dose (20 mg\u002Fday) given as 10 mg twice daily.",[18],{"label":24,"type":15,"description":25,"interventionNames":26},"preterm: low dose of oral UDCA","Neonates will receive oral UDCA solution at 10 mg\u002Fkg twice daily.",[27],"Drug: Ursodeoxycholic acid",{"label":29,"type":10,"description":11,"interventionNames":12},"full-term: control",{"label":31,"type":15,"description":16,"interventionNames":32},"full-term: low dose of oral zinc sulfate",[18],{"label":34,"type":15,"description":21,"interventionNames":35},"full-term: high dose of oral zinc sulfate",[18],{"label":37,"type":15,"description":25,"interventionNames":38},"full-term: low dose of oral UDCA",[27],[40,47],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","Zinc sulfate","Neonates will receive oral Zn sulfate solution in either low doses (10 mg\u002Fday) or high doses (20 mg\u002Fday) given twice daily.",[34,31,20,14],[46],"zinc origin",{"type":41,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Ursodeoxycholic acid","Neonates will receive oral UDCA solution at 10 mg\u002Fday given as 5 mg twice daily.",[37,24],[52],"Livagoal",[54,57,60,62],{"name":55,"affiliation":5,"role":56},"Ehab R. Bendas, professor","STUDY_DIRECTOR",{"name":58,"affiliation":59,"role":56},"Yasmin A. Farid","Ain Shams University",{"name":61,"affiliation":5,"role":56},"Dina K. Abou El Fadl, Lecturer",{"name":63,"affiliation":64,"role":56},"Sarah S. Hesham, Lecturer","Egyptian Chinese University",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":12,"email":70},"Amira M. Fouly, Demonstrator","CONTACT","+20 102 303 3092","amira.mohamed@ecu.edu.eg",{"name":72,"role":68,"phone":73,"phoneExt":12,"email":74},"Dina K. Abou El Fadl, lecturer","+20 100 544 2855","Dkhaled@fue.edu.eg",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":12,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Neonatal Intensive Care Unit (NICU) of Ain Shams University Hospitals","RECRUITING","Cairo","Cairo Governorate","Egypt","EG",{"type":84,"coordinates":85},"Point",[86,87],31.24967,30.06263,{"lat":87,"lon":86},[90],{"name":58,"role":68,"phone":91,"phoneExt":12,"email":92},"01001449558","Yasmin_Ali_Farid@hotmail.com",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Amira Adel Fouly","principal investigator",[98,99],{"name":64,"class":6},{"name":59,"class":6},"100555882","phase-4-efficacy--safety-of-oral-adjuvants-to-phototherapy-in-neonatal-hyperbilirubinemia-100555882",false,"NCT06517862","Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia","Efficacy and Safety of Oral Zinc Sulphate and Ursodeoxycholic Acid as Adjuvants to Phototherapy in Management of Neonatal Non-Hemolytic Unconjugated Hyperbilirubinemia","Inclusion Criteria:\n\n* neonates with both genders\n* neonates with gestational age ≥ 32 weeks\n* neonates who can tolerate enteral feeding\n* diagnosed with unconjugated non-hemolytic hyperbilirubinemia\n* Phototherapy is required within the first week of life.\n\nExclusion Criteria:\n\n* Neonates with seizures, hydrops fetalis, hypoxic-ischemic encephalopathy, or major congenital anomalies\n* Neonates who have had an exchange transfusion within 24 hours\n* neonates have evidence of hemolytic causes of jaundice (e.g., ABO and RH\n* incompatibility, glucose 6-phosphate dehydrogenase deficiency)\n* neonates who have reported hypersensitivity to zinc sulfate or ursodeoxycholic acid.","ALL","1 Day","1 Month",{"count":111,"type":112},80,"ESTIMATED","INTERVENTIONAL",[115],"PHASE4","Neonatal jaundice, or neonatal hyperbilirubinemia, is a common medical issue in the first two weeks of life, causing prolonged hospitalization and readmissions. It results from elevated total serum bilirubin (TSB) and is manifested as yellowish discoloration of the skin, sclera, and mucous membrane. Clinical jaundice appears in about 60% of term neonates and 80% of preterm infants within the first week of life. Pathologic hyperbilirubinemia occurs when bilirubin levels increase by more than 5 mg\u002FdL\u002Fday or 0.2 mg\u002FdL\u002Fhour, or when jaundice lasts longer than two to three weeks in full-term infants. In preterm infants, unconjugated hyperbilirubinemia is of particular concern due to their permeable blood-brain barrier and underdeveloped brain. Phototherapy is widely used to reduce or prevent the rise of serum unconjugated bilirubin levels and reduce the need for exchange transfusions. However, phototherapy has both immediate and long-term side effects, and it can only decrease accumulated UCB but does not prevent its accumulation. There is a growing potential to explore novel adjuvant treatments to increase bilirubin clearance, decrease phototherapy duration, and decrease exchange transfusion rate.",[118],"Neonatal Hyperbilirubinemia",[120,121,122,42,48],"Neonatal hyperbilirubinemia","Phototherapy","exchange transfusion","2026-03-16",{"date":125,"type":126},"2026-03-18","ACTUAL",{"date":128,"type":126},"2024-09-01",{"date":130,"type":112},"2026-06-30",{"name":95,"class":6},1]