[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569405":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":33,"centralContacts":38,"locations":49,"responsibleParty":125,"collaborators":128,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":67,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":171,"overallStatus":70,"whyStopped":67,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Vaginal Birth","Wireless monitoring system placed first for vaginal birth. 15-20 minutes later, the wired monitoring system is placed. Both systems stay in place for 2 hours.",[12,13],"Device: Wireless skin sensors vital sign monitoring system","Device: Wired vital sign monitoring system",{"label":15,"type":6,"description":16,"interventionNames":17},"C-Section Birth","System placement randomized for C-section. One system placed first and the alternate placed immediately after. Both systems stay in place for 2 hours.",[12,13],[19,27],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Wireless skin sensors vital sign monitoring system","The wireless monitoring system will be applied to the newborn and consist of a chest sensor (Anne Arc by Sibel Inc.) and a RAD-7 (Masimo)pulse oximeter limb sensor.",[15,9],[25,26],"Anne Arc (Sibel Health Inc)","Radical-7 (Masimo)",{"type":20,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Wired vital sign monitoring system","A standard ECG and SpO2 monitoring device will be applied suing the Infinity M540 monitor (Draeger, Germany). The chest sensor will be placed as per standard of care on the newborn's chest and abdomen, and the SpO2 sensor on their hands or feet.",[15,9],[32],"Infinity M540 (Draeger)",[34],{"name":35,"affiliation":36,"role":37},"Guilherme Sant'Anna, MD, PhD","The Research institute of the McGill University Health Centre","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Guilherme Sant´Anna, MD, PhD","CONTACT","514-934-1934","27049","guilherme.santanna@mcgill.ca",{"name":46,"role":41,"phone":42,"phoneExt":47,"email":48},"Alyssa Maximov, BSc","78229","alyssa.maximov@muhc.mcgill.ca",[50,68,89,96,111],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Hospital Universitário da Universidade Estadual de Londrina","NOT_YET_RECRUITING","Londrina","Paraná","86038-350","Brazil","BR",{"type":59,"coordinates":60},"Point",[61,62],-51.16278,-23.31028,{"lat":62,"lon":61},[65],{"name":66,"role":41,"phone":67,"phoneExt":67,"email":67},"Adriana Zani",null,{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Montreal Children's Hospital","RECRUITING","Montreal","Quebec","H4A 3J1","Canada","CA",{"type":59,"coordinates":77},[78,79],-73.58781,45.50884,{"lat":79,"lon":78},[82,86,87],{"name":83,"role":41,"phone":84,"phoneExt":85,"email":44},"Guilherme Sant'Anna, MD","1-514-412-4400","23489",{"name":83,"role":37,"phone":67,"phoneExt":67,"email":67},{"name":88,"role":37,"phone":67,"phoneExt":67,"email":67},"Wissam Shalish, MD",{"facility":90,"status":70,"city":71,"state":72,"zip":67,"country":74,"countryCode":75,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Royal Victoria Hospital",{"type":59,"coordinates":92},[78,79],{"lat":79,"lon":78},[95],{"name":35,"role":41,"phone":67,"phoneExt":67,"email":67},{"facility":97,"status":52,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Nuovo Ospedale degli Infermi","Ponderano","BI","13875","Italy","IT",{"type":59,"coordinates":104},[105,106],8.05592,45.53846,{"lat":106,"lon":105},[109],{"name":110,"role":41,"phone":67,"phoneExt":67,"email":67},"Paolo Manzoni, MD",{"facility":112,"status":52,"city":113,"state":114,"zip":67,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Lucerne Cantonal Hospital","Lucerne","Canton of Lucerne","Switzerland","CH",{"type":59,"coordinates":118},[119,120],8.30635,47.05048,{"lat":120,"lon":119},[123],{"name":124,"role":41,"phone":67,"phoneExt":67,"email":67},"Urs Schumacher",{"type":126,"investigatorFullName":83,"investigatorTitle":127,"investigatorAffiliation":5,"oldNameTitle":67,"oldOrganization":67},"SPONSOR_INVESTIGATOR","Senior Clinician Scientist, Professor",[129,131,132],{"name":51,"class":130},"UNKNOWN",{"name":97,"class":130},{"name":133,"class":6},"Luzerner Kantonsspital","100569405","advanced-wireless-sensors-for-neonatal-care-in-the-delivery-room-100569405",false,"NCT06693817","Advanced Wireless Sensors for Neonatal Care in the Delivery Room","Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study","AWARD","Inclusion criteria:\n\n1. Newborns ≥35 weeks (gestational age)\n2. Newborns determined to be clinically stable at delivery\n3. Newborns with no skin abnormalities\n\nExclusion criteria:\n\n1. Newborns ≤ 35 weeks (gestational age)\n2. Newborns determined to not be clinically stable at delivery\n3. Newborns with Skin abnormalities",true,"ALL","35 Weeks","42 Weeks",{"count":147,"type":148},600,"ESTIMATED","INTERVENTIONAL",[151],"NA","The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to:\n\n1. Assess feasibility\n2. Evaluate safety\n3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.",[154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170],"Sudden Unexplained Infant Death","Apnea of Newborn","Newborn Morbidity","Newborn Asphyxia","Birth Outcome, Adverse","Birth Asphyxia","Pregnancy Related","Newborn; Vitality","ECG Electrode Site Reaction","Infant ALL","Infant Death","Infant, Newborn, Diseases","Infant Apnea","Infant Conditions","Parents","Delivery Problem for Fetus","Delivery Complication",[172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197],"Delivery Room","Newborn","Neonatal Resuscitation","Wireless Technology","Vital Sign Monitoring","Sudden Unexplained Post-Natal Collapse","SUPC","Obstetrical Center","Obstetrics","Neonate","Birth","Birthing Center","C-Section","Vaginal Delivery","Sensors","Heart Rate (HR)","Respiratory Rate (RR)","Blood Oxygen Saturation (SpO2)","Skin Temperature (Tskin)","Pulse Rate (PR)","International","Low-Income","Middle-Income","High-Income","Golden Hour","Post-Birth","2026-05-05",{"date":200,"type":201},"2026-05-08","ACTUAL",{"date":203,"type":201},"2025-04-08",{"date":205,"type":148},"2027-12-30",{"name":83,"class":6},5]