[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570053":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":43,"locations":49,"responsibleParty":82,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":11,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":11,"studyType":100,"phases":101,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Regionshospital Nordjylland","OTHER_GOV",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"12 hours continuous double phototherapy with irradiance of over head light of 40 µW\u002Fcm2\u002Fnm","ACTIVE_COMPARATOR",null,[13],"Other: Continuous Phototherapy with a irradiance of 40 µW\u002Fcm2\u002Fnm from the overhead light",{"label":15,"type":10,"description":11,"interventionNames":16},"12 hours continuous double phototherapy with irradiance of over head light of 55 µW\u002Fcm2\u002Fnm",[17],"Other: Continuos Phototherapy with a irradiance of 55 µW\u002Fcm2\u002Fnm from the overhead light",{"label":19,"type":10,"description":11,"interventionNames":20},"12 hours continuous double phototherapy with irradiance of over head light of 70 µW\u002Fcm2\u002Fnm",[21],"Other: Continuous Phototherapy with a irradiance of 70 µW\u002Fcm2\u002Fnm from the overhead light",{"label":23,"type":10,"description":24,"interventionNames":25},"12 hours cycled double phototherapy with irradiance of over head light of 70 µW\u002Fcm2\u002Fnm","This group will receive 12 hours double phototherapy in cycles of 1,5 hours. Thus receiving 1,5 hours treatment, 1,5 hours pause, 1,5 hours treatment etc.",[26],"Other: Cycled phototherapy with a irradiance of 70 µW\u002Fcm2\u002Fnm from the overhead light",[28,33,37,40],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"OTHER","Continuous Phototherapy with a irradiance of 40 µW\u002Fcm2\u002Fnm from the overhead light","The difference in irradiance between the groups will be measured with a radiometer specific to the device's wavelength.",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Continuos Phototherapy with a irradiance of 55 µW\u002Fcm2\u002Fnm from the overhead light","The difference in irradiance between the groups will be measured with a radiometer specific for the device's wavelenght",[15],{"type":29,"name":38,"description":35,"armGroupLabels":39,"otherNames":11},"Continuous Phototherapy with a irradiance of 70 µW\u002Fcm2\u002Fnm from the overhead light",[19],{"type":29,"name":41,"description":35,"armGroupLabels":42,"otherNames":11},"Cycled phototherapy with a irradiance of 70 µW\u002Fcm2\u002Fnm from the overhead light",[23],[44],{"name":45,"role":46,"phone":47,"phoneExt":11,"email":48},"Emil L Oehrstroem, MD","CONTACT","+45 24830384","e.oehrstroem@rn.dk",[50,68],{"facility":51,"status":52,"city":53,"state":11,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Aalborg University Hospital, The Neonatal Department","RECRUITING","Aalborg","9000","Denmark","DK",{"type":58,"coordinates":59},"Point",[60,61],9.9187,57.048,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":66,"phoneExt":11,"email":67},"Lars Bender, MD, consultant","+45 97663355","labe@rn.dk",{"facility":69,"status":52,"city":70,"state":11,"zip":71,"country":55,"countryCode":56,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"The North Denmark Regional Hospital, The Pediatric Department","Hjørring","9800",{"type":58,"coordinates":73},[74,75],9.98229,57.46417,{"lat":75,"lon":74},[78],{"name":79,"role":46,"phone":80,"phoneExt":11,"email":81},"Mette L Roed, MD","+45 97642932","mld@rn.dk",{"type":83,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[85],{"name":86,"class":29},"Aalborg University Hospital","100570053","phase-2-newborn-jaundice---an-investigation-of-different-approaches-to-light-therapy-100570053",false,"NCT06702241","Newborn Jaundice - An Investigation of Different Approaches to Light Therapy","Neonatal Hyperbilirubinemia - Phototherapeutic Treatment Strategies","Inclusion Criteria:\n\n* Hyperbilirubinemia with a total serum bilirubin level above the limit of necessary treatment according to the Danish Pediatric Society's guidelines\n* Birth weight \\>1800g\n* Gestational age \\>33+0\n\nExclusion Criteria:\n\n* Hyperbilirubinemia within the first 24 hours of life\n* Rapidly increasing serum levels of bilirubnemia indicating pathology or hemolysis","ALL","1 Day","14 Days",{"count":98,"type":99},116,"ESTIMATED","INTERVENTIONAL",[102,103],"PHASE2","PHASE3","Background Neonatal jaundice affects about 60% of full-term newborns in their first week. If untreated, it can lead to permanent brain damage. In Denmark, 2-5% of newborns require phototherapy, the standard treatment. The maximum beneficial irradiance limit for phototherapy remains unclear. Furthermore, studies suggest that cycled phototherapy is as effective as continuous treatment.\n\nThis study aims to investigate the efficacy of elevating the irradiance of intensive phototherapy treatment regimens. This is to evaluate the dose-response relationship. Furthermore, the study aims to compare intermittent phototherapy to continuous phototherapy.\n\nMethods:\n\nIn a clinical randomized multicenter trial 116 newborns with non-hemolytic hyperbilirubinemia, gestational age \\>33+0, weight \\>1800g and no other significant neonatal diagnose will be randomized. All infants will receive 12 hours double therapy with a biliblanket and overhead light providing an intensity of either 40-, 55- or 70 µW\u002Fcm2\u002Fnm. Three groups will be treated with continuous phototherapy while a fourth group will receive intermittent phototherapy of 1,5 hours cycled intervals with an intensity of 70 µW\u002Fcm2\u002Fnm.\n\nParental experiences during treatment will be examined through a survey post treatment.\n\nThe study has been approved by the Regional Research Ethics Committee.\n\nPerspectives:\n\nUnderstanding the dose-response relationship of phototherapy will give an insight in the most effective way of treating neonatal jaundice. Intermittent therapy, if proven non-inferior, could facilitate more intimacy in the parent-infant relationship as well as benefits in initiating breastfeeding",[106],"Neonatal Hyperbilirubinemia",[108,109,110,111,112],"Cycled phototherapy","high irradiance phototherapy","Neonatal jaundice","Newborn jaundice","neonatal hyperbilirubinemia","2025-11-17",{"date":115,"type":116},"2025-11-20","ACTUAL",{"date":118,"type":116},"2025-01-14",{"date":120,"type":99},"2029-11-01",{"name":5,"class":6},2]