[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379264":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":48,"collaborators":24,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":24,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Ministry of Health, Saudi Arabia","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-threshold group","ACTIVE_COMPARATOR","Neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol\u002FL below the AAP phototherapy threshold.",[13],"Device: phototherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"High-threshold group","Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol\u002FL below the appropriate AAP phototherapy threshold.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","phototherapy","Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol\u002FL below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol\u002FL of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Fatimah S Alhazmi, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},"CONTACT","00 966 54 0564141","f.alhazmi@hotmail.com",[35],{"facility":36,"status":37,"city":38,"state":24,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":24},"Madinah maternity and children's hospital","RECRUITING","Madinah","42319","Saudi Arabia","SA",{"type":43,"coordinates":44},"Point",[45,46],39.61417,24.46861,{"lat":46,"lon":45},{"type":28,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Fatema Sulaiman Alhazmi","Cilinical fellow, Madinah Maternity and Children's Hospital, NICU","100379264","safe-threshold-to-discontinue-phototherapy-in-hemolytic-disease-of-newborn-100379264",false,"NCT04218318","Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn","Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial","Inclusion Criteria:\n\nHealthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria:\n\n1. positive DAT and blood group iso-immunization (ABO \u002F RH incompatibility);and \u002For\n2. HGB decline by 2g\u002Fdl within 24hour.\n\nExclusion Criteria:\n\n* Major congenital abnormalities,\n* Surgical problems,\n* Direct hyperbilirubinemia\n* Sepsis",true,"ALL","1 Hour","14 Days",{"count":63,"type":64},84,"ESTIMATED","INTERVENTIONAL",[67],"NA","We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn.\n\nObjectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.",[70,71],"Hemolytic Disease of Newborn","Neonatal Hyperbilirubinemia",[73,74,75,76,77,78],"Jaundice","Newborn","Hyperbilirubinemia","Rebound hyperbilirubinemia","Phototherapy","Hemolysis","2025-01-01",{"date":81,"type":82},"2025-01-03","ACTUAL",{"date":84,"type":82},"2019-10-01",{"date":86,"type":64},"2027-01-01",{"name":5,"class":6},1]