[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657420":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":21,"interventions":21,"overallOfficials":27,"centralContacts":35,"locations":21,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":21,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":21,"studyType":65,"phases":21,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":76,"whyStopped":21,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":21},{"fullName":5,"class":6},"Tampere University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Agreement between heart rate measurements obtained from the smart sock and the standard patient monitor","Heart rate data obtained from the smart sock will be compared with simultaneous heart rate data obtained from the standard patient monitor used in routine neonatal care.","From initiation of smart sock monitoring through completion of the 12-16-hour monitoring period",[14,17],{"measure":15,"description":16,"timeFrame":12},"Agreement in detection of rhythm abnormalities between the smart sock and the standard patient monitor","Rhythm abnormalities and rhythm-related alarms identified by the standard patient monitor will be reviewed and compared with data obtained from the smart sock to assess the ability of the smart sock to detect clinically significant rhythm abnormalities lasting \\>3 minutes.",{"measure":18,"description":19,"timeFrame":20},"Parent- and healthcare professional-reported usability of the smart sock","Usability of the smart sock as assessed by parents and healthcare professionals using a questionnaire.","Immediately after completion of the 12-16-hour smart sock monitoring period",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","Commercially available wearable monitoring devices for infants are increasingly used, but evidence on their performance in hospitalized newborns is limited. This study evaluates the accuracy and usability of the Owlet Dream Sock™ in hospitalized newborn infants. Heart rate and rhythm data obtained from the smart sock will be compared with data from the standard patient monitor used in routine neonatal care. In addition, parents and healthcare professionals will evaluate the usability and perceived safety of the device.","Hospitalized full-term and late preterm newborn infants receiving care in the neonatal intensive care unit and observation unit at Tampere University Hospital, Finland.",[28,32],{"name":29,"affiliation":30,"role":31},"Tuija H Poutanen, MD, PhD","Tampere University Hospital, Wellbeing Services County of Pirkanmaa","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Merja Kallio, MD, PhD","New Children's Hospital, Helsinki University Hospital and University of Helsinki",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":21,"email":40},"Kirsi Ylä-Tuuhonen, MD","CONTACT","+358 44 472 8190","kirsi.yla-tuuhonen@pirha.fi",{"name":42,"role":38,"phone":43,"phoneExt":21,"email":44},"Minna Mecklin, MD, PhD","+358 44 472 8153","minna.mecklin@pirha.fi",{"type":46,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[48],{"name":49,"class":50},"Owlet Baby Care, Inc.","INDUSTRY","100657420","smart-sock-heart-rate-monitoring-in-hospitalized-newborns-100657420",false,"NCT07838402","Smart Sock Heart Rate Monitoring in Hospitalized Newborns","Evaluation of a Smart Sock for Heart Rate Monitoring in Hospitalized Newborn Infants","Inclusion Criteria:\n\n* Hospitalized newborn infant\n* Age \\\u003C28 days\n* Gestational age ≥35+0 weeks\n* Birth weight ≥2 kg\n* Parental informed consent\n\nExclusion Criteria:\n\n* Known congenital heart disease\n* Hospital-acquired infection\n* Skin infection\n* Lack of parental consent",true,"ALL","0 Days","28 Days",{"count":63,"type":64},40,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate a commercially available smart sock for heart rate monitoring in hospitalized newborn infants without known heart disease. The study aims to determine whether the smart sock provides heart rate information comparable to that obtained from the standard patient monitor used in routine neonatal care.\n\nThe main questions this study aims to answer are:\n\n* Does the smart sock provide heart rate measurements comparable to those obtained from the standard patient monitor?\n* Does the smart sock provide comparable information on clinically relevant rhythm abnormalities?\n* How do parents and healthcare professionals perceive the usability and safety of the smart sock? Participants will wear the smart sock while undergoing routine monitoring on the neonatal ward. Heart rate and rhythm data from the smart sock will be compared with data from the standard patient monitor. Parents and healthcare professionals will provide feedback on the usability and perceived safety of the device.",[68,69],"Healthy","Newborn Infant",[71,72,73,74,75],"newborn infant","heart rate monitoring","wearable devices","neonatal monitoring","cardiac rhythm","NOT_YET_RECRUITING","2026-09-22",{"date":79,"type":80},"2026-09-24","ACTUAL",{"date":82,"type":64},"2026-09-30",{"date":84,"type":64},"2027-02",{"name":5,"class":6}]