[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649740":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":10,"responsibleParty":32,"collaborators":10,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":39,"acronym":10,"eligibilityCriteria":40,"healthyVolunteers":41,"sex":42,"minAge":10,"maxAge":43,"enrollmentInfo":44,"targetDuration":10,"studyType":47,"phases":10,"briefSummary":48,"conditions":49,"keywords":53,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":10},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Newborn Infants",null,"Healthy newborn infants enrolled in the study who will undergo simultaneous monitoring with the Wireless MicroPremVitals Button Sensor System and standard-of-care monitoring in the delivery room to evaluate the accuracy, safety, and feasibility of the wireless monitoring system.",[13],"Device: Wireless MicroPremVitals Button Sensor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Wireless MicroPremVitals Button Sensor","A wireless wearable sensor system applied to newborn infants in the delivery room to continuously measure electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature. Measurements will be compared with standard-of-care monitoring for validation purposes only and will not be used for clinical decision-making.",[9],[21],{"name":22,"affiliation":23,"role":24},"Guilherme Sant'Anna, MD, PhD","RI-MUHC","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Alyssa Maximov, BSc.","CONTACT","5149341934","78229","alyssa.maximov@muhc.mcgill.ca",{"type":24,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Guilherme Sant'Anna, MD","Neonatologist","100649740","miniaturized-vital-sign-monitoring-for-newborns-in-the-delivery-room-100649740",false,"NCT07739810","Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room","Inclusion Criteria:\n\n\\- Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.\n\nExclusion Criteria:\n\n* Infants with skin abnormality would potentially increase the risk of injury.\n* Family experiencing too much stress as determined by an attending physician or bedside care team, to not be approached for recruitment.\n* Infants born at \\\u003C35 weeks gestational age.",true,"ALL","24 Hours",{"count":45,"type":46},5,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the Wireless MicroPremVitals Button Sensor System for continuous monitoring of electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature in newborn infants in the delivery room. Measurements obtained from the wireless sensor system will be compared with standard-of-care monitoring. The study will also assess skin tolerability, signal quality, and parent and healthcare provider perceptions of the device.",[50,51,52],"Vital Signs Monitoring","Newborn Monitoring","Physiologic Monitoring",[54,55,56,57,58,59,60,61,62],"Wireless monitoring","Vital signs","Newborn","Neonate","Delivery room","Wearable sensor","Electrocardiography","Respiratory rate","Skin temperature","NOT_YET_RECRUITING","2026-07-28",{"date":66,"type":67},"2026-07-31","ACTUAL",{"date":69,"type":46},"2026-09-01",{"date":71,"type":46},"2027-09-01",{"name":5,"class":6}]