[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651183":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":18,"locations":28,"responsibleParty":47,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Medical University of Graz","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"neonate with therapeutic hypothermia",null,[12],"Device: continous temperature measurement",[14],{"type":15,"name":16,"description":16,"armGroupLabels":17,"otherNames":10},"DEVICE","continous temperature measurement",[9],[19,24],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Nariae Baik-Schneditz, PhD. M.D.","CONTACT","+43 316 385 82677","nariae.baik@medunigraz.at",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},"Lukas Mileder, PhD. M.D.","+43 316 385 81052","lukas.mileder@medunigraz.at",[29],{"facility":30,"status":10,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Medical University Graz","Graz","Styria","8034","Austria","AT",{"type":37,"coordinates":38},"Point",[39,40],15.44197,47.06733,{"lat":40,"lon":39},[43],{"name":44,"role":21,"phone":45,"phoneExt":10,"email":46},"Gerhard Pichler, Prof.","+43 316 385 80520","gerhard.pichler@medunigraz.at",{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100651183","continuous-monitoring-of-body-temperature-in-neonates-during-therapeutic-hypothermia-100651183",false,"NCT07756892","Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia","Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia - A Prospective Observational Pilot Study","MonT HT","Inclusion Criteria:\n\n* Neonates born at ≥36+0 weeks of gestation.\n* Clinical indication for therapeutic hypothermia.\n* Written informed consent obtained from the parents or legal guardians before study measurements are initiated.\n\nExclusion Criteria:\n\n* Gestational age \\\u003C36+0 weeks.\n* No clinical indication for therapeutic hypothermia.\n* Written informed consent not obtained from the parents or legal guardians.\n* Congenital malformation.","ALL","3 Days","1 Week",{"count":61,"type":62},10,"ESTIMATED","OBSERVATIONAL","This prospective observational pilot study aims to evaluate the feasibility, accuracy, and safety of the SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring in neonates undergoing therapeutic hypothermia following hypoxic-ischemic encephalopathy. Currently, body temperature during therapeutic hypothermia is monitored using an invasive rectal temperature probe, which carries risks such as tissue injury, perforation, infection, and patient discomfort.\n\nThe study will enroll ten neonates born at ≥36 weeks of gestation who require therapeutic hypothermia. During the rewarming phase of treatment, the SteadyTemp® adhesive thermometer will be applied to the right axillary area for approximately 10 hours while routine rectal temperature monitoring continues. Temperature measurements obtained with the adhesive thermometer will be compared with simultaneous rectal core temperature measurements. In addition, skin condition after removal of the adhesive patch will be assessed using the Neonatal Skin Condition Scale (NSCS) to evaluate local tolerability.\n\nThe study seeks to answer the following research questions:\n\nCan the SteadyTemp® adhesive thermometer continuously and reliably monitor body temperature in neonates during therapeutic hypothermia? Do temperature measurements obtained with the non-invasive adhesive thermometer show sufficient agreement with standard invasive rectal temperature measurements, including temperatures below 36°C? Is prolonged application of the adhesive thermometer safe and well tolerated, without causing clinically relevant skin irritation?\n\nThe findings from this pilot study will provide preliminary evidence on the feasibility and agreement of this non-invasive monitoring method and will inform the design of larger validation studies investigating whether the SteadyTemp® adhesive thermometer could serve as a safe alternative to invasive rectal temperature monitoring during therapeutic hypothermia in neonates.",[66,67,68],"Therapeutic Hypothermia","Neonatal Hypoxic-Ischemic Encephalopathy","Neonatal Thermal Management",[16,70,71],"neonate","hypothermia","NOT_YET_RECRUITING","2026-08-05",{"date":75,"type":76},"2026-08-11","ACTUAL",{"date":78,"type":62},"2026-08-15",{"date":80,"type":62},"2028-08-15",{"name":5,"class":6},1]