[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580487":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":40,"responsibleParty":55,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Taipei Medical University Shuang Ho Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aluminum Foil Reflector Group","EXPERIMENTAL","This group includes newborns who require phototherapy with an Aluminum Foil Reflector.",[13],"Device: Aluminum Foil Reflector",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","This group includes newborns requiring phototherapy and not using an Aluminum Foil Reflector.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Aluminum Foil Reflector","The hyperbilirubinemia newborns will receive phototherapy with an Aluminum Foil Reflector around an incubator. The aluminum foil reflector, sewn inside a cloth that is 30 cm long and 3 mm thick, will be hung from the three sides of the phototherapy unit. The reflector will cover the whole incubator except for the foot part to allow infant observation during treatment. While receiving phototherapy, the lights will be continuously on, except during feeding, physical examination, and blood taking. All participants will dress only in nappies and eye masks during phototherapy treatment.\n\nSerum bilirubin will be taken every 24 hours until phototherapy can be stopped according to AAP guidelines.",[9],[26],{"name":27,"affiliation":5,"role":28},"Ka-Wai Tam","STUDY_DIRECTOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"SunPeng Chang","CONTACT","+886-2249-0088","2660","09055@s.tmu.edu.tw",{"name":37,"role":32,"phone":38,"phoneExt":18,"email":39},"Le Thy Phuong Anh","+886-987133290","d142113019@tmu.edu.tw",[41],{"facility":42,"status":18,"city":43,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Shuangho Hospital","New Taipei City","Taiwan","TW",{"type":47,"coordinates":48},"Point",[49,50],121.45703,25.06199,{"lat":50,"lon":49},[53],{"name":31,"role":32,"phone":54,"phoneExt":18,"email":35},"0912028058",{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100580487","aluminum-foil-reflector-on-phototherapy-for-newborn-with-jaundice-100580487",false,"NCT06837935","Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice","Effect of Aluminum Foil Reflector on Phototherapy for Newborn Infants with Unconjugated Hyperbilirubinemia: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Newborns who are admitted to the neonatal ward for examination and treatment due to jaundice levels reaching the treatment threshold.\n2. Term babies below 14 days of age (gestational age of 37 weeks or greater).\n3. No evidence of hemolysis\n\nExclusion Criteria:\n\n1. Infants with serum bilirubin levels close to the exchange transfusion limit\n2. Hemolytic disease (Ex: G6PD)\n3. Congenital anomalies\n4. Elevated direct bilirubin\n5. Infants with abnormal liver function or biliary structure\n6. Infants who receive Cardiopulmonary Resuscitation after birth or suspected perinatal asphyxia","ALL","1 Hour","14 Days",{"count":68,"type":69},160,"ESTIMATED","INTERVENTIONAL",[72],"NA","Hyperbilirubinemia is defined as the presence of bilirubin in the serum of newborns at levels exceeding the normal range. It is the most common problem among healthy newborns, with an incidence of approximately 40% to 60% in full-term infants. The primary cause is the immature bilirubin metabolism in newborns, leading to the accumulation of excess bilirubin in the blood, which in turn results in a temporary yellowing of the skin and sclera, known as jaundice. Physiological jaundice in full-term newborns typically appears 24 to 72 hours after birth, peaking on days 4 to 5. Studies have shown that neonatal jaundice is a leading cause of readmission after discharge.\n\nPhototherapy is the most effective and safest treatment for neonatal hyperbilirubinemia. It takes advantage of bilirubin's sensitivity to light, converting bilirubin into water-soluble conjugated bilirubin, which is then excreted through bile and urine, thereby reducing total bilirubin levels. The most effective light during phototherapy has a wavelength of 400 nm to 520 nm and an intensity of at least 30 microW\u002Fcm²\u002Fnm, with at least 80% of the infant's body surface area exposed.\n\nThis study aims to investigate whether using aluminum foil reflective covering around the phototherapy incubator can enhance the effectiveness of light treatment for jaundice in infants, thus potentially reducing the duration of phototherapy required.",[75],"Newborn Jaundice",[22,77,78,79],"Phototherapy","Newborn","Hyperbilirubinemia","NOT_YET_RECRUITING","2025-03-23",{"date":83,"type":84},"2025-03-26","ACTUAL",{"date":86,"type":69},"2025-05-01",{"date":88,"type":69},"2026-12-31",{"name":5,"class":6},1]