[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627794":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":24,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":71,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"THERMOREGULATION BUNDLE GROUP","EXPERIMENTAL","Newborns in this group will receive a Thermoregulation Package immediately after birth. The package includes the following:\n\n1. The delivery room temperature should be between 23-26 degrees Celsius.\n2. Skin-to-skin contact should be initiated as soon as the baby is born.\n3. The baby should be dried starting from the head with a warm towel and a hat should be put on.\n4. The baby should be covered with a warm towel during skin-to-skin contact.\n5. The baby should be breastfed immediately (within the first 30-60 minutes). All components of the package will be applied according to an all-or-nothing approach.",[13],"Other: Thermoregulation bundle",{"label":15,"type":6,"description":16,"interventionNames":17},"CONTROL GROUP","Newborns in this group will receive routine delivery room care according to the standard hospital protocol. No structured thermoregulation bundle will be applied.",[18],"Other: routine care",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Thermoregulation bundle","A structured set of evidence-based thermal care interventions applied immediately after birth, including maintaining appropriate delivery room temperature, immediate drying with warm linens, removal of wet towels, application of a hat, early skin-to-skin contact for the first hour, and covering the newborn with a warm blanket. The bundle is implemented using an all-or-nothing approach.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"routine care","Standard delivery room care according to institutional protocol.",[15],[30],{"name":31,"affiliation":32,"role":33},"gülçin bozkurt, Professor Doctor","istanbul üniversitesi cerrahpaşa sağlık bilimleri fakültesi","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"yeşim dilki, student","CONTACT","+905010732834","yesimdilki@ogr.iuc.edu.tr",{"name":31,"role":37,"phone":41,"phoneExt":24,"email":42},"+905336349093","gbozkurt@iuc.edu.tr",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":24,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi","RECRUITING","Kocaeli","darıca","41000","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],27.51145,39.62497,{"lat":55,"lon":54},[58],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","yeşim dilki","study director","100627794","effect-of-thermoregulation-bundle-applied-at-birth-on-neonatal-physiological-parameters-and-breastfeeding-100627794",false,"NCT07453264","Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding","Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding: A Randomized Controlled Trial","Inclusion Criteria:\n\n* The baby is born vaginally\n* It is a singleton pregnancy,\n* The baby is born at term (gestational age 38-42 weeks),\n* The baby's Apgar score is ≥ 7 at 1 minute,\n* The baby's birth weight is between 2500-4000 grams,\n* The baby is exclusively breastfed,\n* The baby has no problems preventing breastfeeding,\n* The mother has no problems preventing breastfeeding,\n* There are no maternal or fetal complications.\n\nExclusion Criteria:\n\n* The baby being preterm\u002Fpostterm,\n* Starting formula feeding,\n* The baby having special care needs (intensive care, etc.),\n* The baby having intrauterine growth restriction (IUGR), genetic disease, etc.","ALL","2 Hours",{"count":73,"type":74},140,"ESTIMATED","INTERVENTIONAL",[77],"NA","Maintaining neonatal body temperature (thermoregulation), particularly during the first hour after birth, is critical for survival and successful adaptation to the extrauterine environment. Implementation of a thermoregulation bundle is expected to facilitate faster stabilization of physiological parameters and to positively influence the initiation of breastfeeding as well as overall breastfeeding success. The effects of a thermoregulation bundle applied at birth on neonatal physiological parameters-including body temperature, respiratory rate, heart rate, and oxygen saturation-and on breastfeeding outcomes will be evaluated.",[80,81,82],"Thermoregulation","Neonatal Hypothermia","Neonatal Adaptation",[84,85,86,87,88,89],"thermoregulation bundle","term newborn","neonatal hypothermia","skin-to-skin contact","delivery room care","physiological parameters","2026-05-03",{"date":92,"type":93},"2026-05-05","ACTUAL",{"date":95,"type":93},"2025-11-01",{"date":97,"type":74},"2026-08-30",{"name":5,"class":6},1]