[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488261":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":80,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":20,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":20,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SpO2 and PIx Measurement","EXPERIMENTAL","Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters and a ML CCHD screening algorithm will be assigning a prediction every minute.",[13],"Diagnostic Test: SpO2\u002FPIx Measurement and ML Algorithm",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","SpO2\u002FPIx Measurement and ML Algorithm","Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured and an online ML inference model will be used to classify a newborn as healthy versus CCHD as new pulse oximetry data is collected.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Heather Siefkes, MD, MSCI","CONTACT","916-713-7697","hsiefkes@ucdavis.edu",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Elva Horath, IMG","ethorath@ucdavis.edu",[31,49,65],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"UC Davis Medical Center","RECRUITING","Davis","California","95616","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-121.74052,38.54491,{"lat":43,"lon":42},[46,47],{"name":23,"role":24,"phone":20,"phoneExt":20,"email":26},{"name":23,"role":48,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Cohen Children's Medical Center","NOT_YET_RECRUITING","Queens","New York","11040",{"type":40,"coordinates":56},[57,58],-73.83652,40.68149,{"lat":58,"lon":57},[61,64],{"name":62,"role":24,"phone":20,"phoneExt":20,"email":63},"Robert Koppel, MD","rkoppel@northwell.edu",{"name":62,"role":48,"phone":20,"phoneExt":20,"email":20},{"facility":66,"status":51,"city":67,"state":68,"zip":69,"country":37,"countryCode":38,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of Utah Health Care","Salt Lake City","Utah","84102",{"type":40,"coordinates":71},[72,73],-111.89105,40.76078,{"lat":73,"lon":72},[76,79],{"name":77,"role":24,"phone":20,"phoneExt":20,"email":78},"Whitnee Hogan, MD","whitnee.hogan@hsc.utah.edu",{"name":77,"role":48,"phone":20,"phoneExt":20,"email":20},{"type":81,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[83],{"name":84,"class":85},"National Institutes of Health (NIH)","NIH","100488261","dynamic-critical-congenital-heart-screening-with-addition-of-perfusion-measurements-100488261",false,"NCT05637814","Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements","Inclusion Criteria:\n\n* Age \\\u003C 22 days\n* Fetuses suspected to have congenital heart disease\n* Newborns with suspected\u002Fconfirmed critical congenital heart disease\n* Asymptomatic newborn undergoing SpO2 screening for CCHD\n\nExclusion Criteria:\n\n* Echocardiogram completed prior to enrollment as the newborn would then no longer be considered \"asymptomatic undergoing SpO2 screening for CCHD\"\n* For Newborns with confirmed\u002Fsuspected congenital heart disease (CHD): a) Patent ductus arteriosus and\u002For atrial septal defect\u002Fpatent foramen ovale without other defects, b) Corrective cardiac surgical or catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.",true,"ALL","0 Minutes","21 Days",{"count":97,"type":98},320,"ESTIMATED","INTERVENTIONAL",[101],"NA","The purpose of this study is to implement and externally validate an inpatient ML algorithm that combines pulse oximetry features for critical congenital heart disease (CCHD) screening.",[104],"Congenital Heart Disease",[106,107],"Machine Learning Algorithm","Pulse Oximetry","2026-06-16",{"date":110,"type":111},"2026-06-18","ACTUAL",{"date":113,"type":111},"2023-08-17",{"date":115,"type":98},"2027-12-31",{"name":5,"class":6},3]