[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559535":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Babies in the Owlet monitor group","EXPERIMENTAL","The Owlet group will be given an Owlet OSS 3.0 monitor to wear when sleeping. The Owlet alarms if the baby has a very low heart rate or very low oxygen levels. In addition, caregivers in the Owlet group with a smart phone and Wi-Fi access will be able to use an application to monitor the baby's vital signs and sleep state. Will complete a survey or questionnaire every month until 6 months after discharge.",[13],"Device: Babies in the Owlet monitor group",{"label":15,"type":16,"description":17,"interventionNames":18},"Babies in the Usual Care Group","NO_INTERVENTION","The usual care group will not be given an Owlet vital sign monitor. Will complete a survey or questionnaire every month until 6 months after discharge.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","The Owlet group will be given an Owlet OSS 3.0 monitor to wear when sleeping. The Owlet alarms if the baby has a very low heart rate or very low oxygen levels. In addition, caregivers in the Owlet group with a smart phone and Wi-Fi access will be able to use an application to monitor the baby's vital signs and sleep state.",[9],[25],{"name":26,"affiliation":5,"role":27},"Colm P Travers, M.D.","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Kimberly Armstead, BS","CONTACT","205-934-0095","karmstead@uabmc.edu",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Rachel Benz, MSN","205-934-4680","rbenz@uabmc.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Birmingham","Alabama","35249","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-86.80249,33.52066,{"lat":50,"lon":49},[53,57],{"name":54,"role":31,"phone":55,"phoneExt":18,"email":56},"Colm Travers, MD","2053545008","colmtravers@hotmail.com",{"name":30,"role":31,"phone":18,"phoneExt":58,"email":33},"2059344680",{"type":27,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Colm Travers","Assistant Professor",[63],{"name":64,"class":65},"Owlet Baby Care, Inc.","INDUSTRY","100559535","remote-oximeter-monitoring-post-discharge-to-reduce-emergency-room-visits-and-rehospitalization-100559535",false,"NCT06565390","Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization","Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): A Randomized Clinical Trial","ROMPER","Inclusion Criteria:\n\n* Infants being discharged from the NICU\n* Off all respiratory support (oxygen, CPAP, ventilator) before discharge home\n* Gestational age ≥ 22 0\u002F7 weeks' gestation at birth\n* Parents\u002Flegal guardians have provided consent for enrollment\n\nExclusion Criteria:\n\n* a major malformation, a neuromuscular condition that affects respiration or causes apnea, complex congenital heart disease and hemodynamically significant shunts, or terminal illness or decision to withhold or limit support.\n* Infants being discharged from the neonatal intensive care unit (NICU) with a cardiorespiratory monitor or respiratory support are not eligible for inclusion.","ALL","22 Weeks","6 Months",{"count":78,"type":79},700,"ESTIMATED","INTERVENTIONAL",[82],"NA","This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for the reduction of emergency room visits and high-acuity rehospitalizations among high-risk infants after NICU discharge.",[85],"Emergencies","2025-09-24",{"date":88,"type":89},"2025-09-30","ACTUAL",{"date":91,"type":89},"2025-09-11",{"date":93,"type":79},"2030-12-31",{"name":5,"class":6},1]