[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-hypothermia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-hypothermia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Thermoregulation","Neonatal Hypothermia","Neonatal Adaptation",[30,31,32,33,34,35],"thermoregulation bundle","term newborn","neonatal hypothermia","skin-to-skin contact","delivery room care","physiological parameters","RECRUITING","2026-05-03",{"date":39,"type":40},"2026-05-05","ACTUAL",{"date":42,"type":40},"2025-11-01",{"date":44,"type":20},"2026-08-30",{"name":46,"class":47},"Istanbul University - Cerrahpasa","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":4,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100577805","investigation-of-the-mechanisms-of-the-tendency-to-hypothermia-in-newborns-and-premature-neonates-100577805","NCT06803069","Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates","Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Infants During Surgical Interventions and in the Intensive Care Unit (Non-Interventional, Single-Center, Prospective Clinical Research)","Inclusion Criteria:\n\n* For Substudy 1: Patients admitted to the Neonatal Intensive Care Unit at the University of Pécs, Department of Obstetrics and Gynaecology (premature infants or those in neonatal intensive care).\n* For Substudy 2: Patients under 2 years of age undergoing elective surgery lasting more than 30 minutes at the University of Pécs, Department of Paediatrics.\n* For both substudies: Written consent for participation in the study has been provided by the patient's parent, guardian, or legal representative.\n\nExclusion Criteria:\n\n* For both substudies: If the patient cannot be mobilized (e.g., during the post-operative phase of abdominal or thoracic surgery; presence of chest tubes for pneumothorax or other reasons; hemodynamic instability; need for continuous electrocardiogram (ECG) monitoring; or use of an external pacemaker).\n* The patient's parent, guardian, or legal representative does not consent to the study or withdraws their consent at any point.\n* For Substudy 2: if the patient is older than 2 years.",true,"2 Years",{"count":59,"type":20},100,"OBSERVATIONAL","Newborns have thermoregulatory mechanisms that differ from those of adults. Instead of producing heat through shivering, newborns primarily rely on non-shivering thermogenesis by the brown adipose tissue. The development of this thermogenic tissue starts around the 26th gestational week and continues until shortly before birth, after which no further growth occurs. As a result, premature infants, who have less developed brown fat, are more prone to reduced heat production and are at higher risk for hypothermia. There are few human studies examining the thermoregulatory differences and mechanisms between full-term and premature neonates, and the findings remain inconclusive.\n\nIn this study, the investigators aim to conduct a prospective, observational research. Researchers will compare body temperature, brown adipose tissue activity, and specific plasma markers between full-term and premature neonates in insensive care units and during elective surgeries.",[27,63,64,65,66,67],"Brown Adipose Tissue","Preterm and Term Infants","Neonate","Thermogenesis","Blood Markers",[69,70,32,71,72,73,74],"brown adipose tissue","neonate","preterm","nonshivering thermogenesis","infant","newborn","2025-02-18",{"date":77,"type":40},"2025-02-19",{"date":79,"type":40},"2024-07-01",{"date":81,"type":20},"2029-07-01",{"name":83,"class":47},"University of Pecs",2,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":48},"100516332","efficacy-of-celsi-warmer-for-the-management-of-hypothermic-newborns-at-the-lagos-university-teaching-hospital-in-lagos-nigeria-100516332","NCT06003140","Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria","Efficacy of Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria","Inclusion Criteria:\n\nAny neonate who:\n\n1. Is currently being treated at study location,\n2. Is an inborn admission to the neonatal ward,\n3. Whose parents or guardians provided informed consent,\n4. Whose parents or guardians providing informed consent are 18 years old or older,\n5. Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0 kg,\n6. Has been identified as in need of thermal care defined as having a moderate to severe hypothermic temperature (32.0-36.0 °C) as the last temperature recorded in hospital chart, or during recruitment procedures; and\n7. is unable to be enrolled in Kangaroo Mother Care (KMC) for reasons including, but not limited to: a. Mother\u002Fguardian unable or unavailable to provide KMC b. Under observation in the Neonatal Intensive Care Unit (NICU) before transfer to KMC c. No space in KMC d. Clinician's discretion;\n8. May be receiving other medical treatments, including but not limited to, Continuous Positive Airway Pressure (CPAP), oxygen therapy, intravenous (IV) fluids, management and monitoring of common newborn conditions such as hypoglycemia, and\u002For hyperbilirubinemia.\n\nExclusion Criteria:\n\n1. Requires mechanical ventilation;\n2. Is deemed in need of intensive care by the hospital staff who is providing care, including but not limited to: a. neonates with severe anemia and\u002For any suspected hematological disorders, and\u002For b. Neonates with obvious congenital anomalies, and\u002For c. neonates suspected with hypo\u002Fhyperthyroidism or any hormonal disorders;\n3. has been diagnosed with birth asphyxia;\n4. Presents a condition that precludes the use of the temperature sensor and\u002For abdominal belt including but not limited to, known umbilical cord infection, known skin infection;\n5. Whose clinician presents concerns about their participation;\n6. Is receiving treatment that participation in the study would interfere with (e.g. transferring to KMC).","1 Day","28 Days",{"count":95,"type":20},90,[23],"The prevalence of hypothermia across low-resource settings is high, especially in countries with high neonatal mortality rates. If left untreated, hypothermia can additionally result in a significant comorbidity, and has been linked to a reduction in the effectiveness of treatment for other newborn conditions. Effective thermal care for hypothermic newborns is not widely available in low-resource settings due to cost of consumables and spare parts. In this study, the research team wish to evaluate the efficacy of a novel neonatal warming mattress in treating hypothermic newborns. Warming mattress, 'Celsi Warmer', has been developed by Rice 360 Institute for Global Health Technologies, in conjunction with African clinicians, to be a robust, low-cost, and easy-to-use warming mattress which can address the challenges of hypothermia. This is a single-arm, non-randomized, prospective intervention study. Up to 90 eligible infants at the neonatal wards of the Lagos University Teaching Hospital will be recruited to evaluate the efficacy of Celsi Warmer in rewarming hypothermic newborns. Infants temperature will be monitored during thermal intervention and the performance of the device will be evaluated. The temperatures of each infant will be compared before, during, and after the intervention.",[27],"2024-06-05",{"date":101,"type":40},"2024-06-07",{"date":103,"type":40},"2023-08-15",{"date":105,"type":20},"2024-10-21",{"name":107,"class":47},"William Marsh Rice University"]