[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656833":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":11,"studyPopulation":11,"armGroups":31,"interventions":40,"overallOfficials":45,"centralContacts":52,"locations":58,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":11,"overallStatus":95,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Sensitivity for Detecting Congenital Heart Disease Requiring Clinical Intervention",null,"From enrollment to the end of treatment at 6 months",[14,16,18,20,23],{"measure":15,"description":11,"timeFrame":12},"Specificity for Detecting Congenital Heart Disease Requiring Clinical Intervention",{"measure":17,"description":11,"timeFrame":12},"Sensitivity for Detecting All Congenital Heart Disease",{"measure":19,"description":11,"timeFrame":12},"Positive Predictive Value for Detecting Congenital Heart Disease Requiring Clinical Intervention",{"measure":21,"description":11,"timeFrame":22},"Referral Completion Rate","From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months",{"measure":24,"description":11,"timeFrame":22},"Confirmed Diagnosis Rate After Referral",{"allocation":26,"interventionModel":27,"interventionModelDescription":11,"primaryPurpose":28,"observationalModel":11,"timePerspective":11,"maskingInfo":29},"RANDOMIZED","PARALLEL","SCREENING",{"masking":30,"maskingDescription":11,"whoMasked":11},"NONE",[32,35],{"label":33,"type":34,"description":11,"interventionNames":11},"Primary care physicians","NO_INTERVENTION",{"label":36,"type":37,"description":11,"interventionNames":38},"AI + Primary care physicians","EXPERIMENTAL",[39],"Other: AI-Assisted Cardiac Auscultation",[41],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"AI-Assisted Cardiac Auscultation","During the school-based screening visit, a trained primary care physician will perform standardized cardiac auscultation and record the participant's heart sounds. The recorded heart sounds will be analyzed by an artificial intelligence-assisted auscultation system, which will provide automated analysis and decision-support feedback to the physician. The physician will consider the AI output together with the clinical examination and make the final screening and referral decision. The AI output is not a definitive diagnosis and will not replace echocardiography or specialist evaluation. No medication, surgery, or other therapeutic treatment will be administered as part of this intervention.",[36],[46,49],{"name":47,"affiliation":5,"role":48},"Kun Sun","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":51,"role":48},"Xiulian Jiang","Women and Children Hospital of Qinghai Province",[53],{"name":54,"role":55,"phone":56,"phoneExt":11,"email":57},"Liudan Zhao","CONTACT","0086-18368407858","sjdyszld@sjtu.edu.cn",[59],{"facility":60,"status":11,"city":61,"state":61,"zip":11,"country":62,"countryCode":63,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Qinghai Provincial Women and Children's Hospital","Qinghai","China","CN",{"type":65,"investigatorFullName":47,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Professor of Department of Pediatric Cardiology",[68,70],{"name":69,"class":6},"Bill and Melinda Gates Foundation",{"name":51,"class":6},"100656833","ai-assisted-versus-independent-heart-sound-screening-for-congenital-heart-disease-in-children-100656833",false,"NCT07830251","AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children","A Prospective, School-Based, Cluster-Randomized Controlled Trial Comparing AI-Assisted Versus Independent Cardiac Auscultation by Primary Care Physicians for Detecting Congenital Heart Disease in Qinghai Province, China","Inclusion Criteria:\n\n* Children and adolescents aged 0-18 years who are enrolled in a participating school in Qinghai Province and are eligible for the school-based congenital heart disease screening program.\n* Written informed consent provided by the parent or legal guardian, or ethics-approved electronic informed consent, with participant assent obtained when applicable.\n* Ability to undergo the protocol-specified cardiac auscultation, heart-sound recording, and echocardiographic assessment.\n* Participant and\u002For parent or legal guardian is willing to provide the required medical history and, if referral is recommended, follow-up information.\n\nExclusion Criteria:\n\n* Inability to cooperate with cardiac auscultation, heart-sound recording, or echocardiography, when the required procedure cannot be completed after reasonable attempts.\n* Known congenital heart disease previously treated with catheter-based intervention or cardiac surgery, when the primary endpoint is not applicable under the protocol.\n* Any condition that prevents completion of the required study procedures or prevents obtaining an interpretable protocol-specified echocardiographic assessment.\n* Informed consent or assent is not provided, or consent is withdrawn before completion of the study procedures.",true,"ALL","0 Years","18 Years",{"count":83,"type":84},10000,"ESTIMATED","INTERVENTIONAL",[87],"NA","This is a prospective, school-based, cluster-randomized controlled trial conducted in Qinghai Province, China. The study will evaluate whether artificial intelligence (AI) can help primary care physicians identify congenital heart disease (CHD) during large-scale screening of children and adolescents.\n\nEligible schools, rather than individual participants, will be randomly assigned to one of two screening approaches: independent cardiac auscultation by primary care physicians or AI-assisted cardiac auscultation. In both groups, primary care physicians will perform cardiac auscultation and record heart sounds. In the AI-assisted group, the physicians will also receive AI analysis of the recorded heart sounds to support their final screening decision.\n\nParticipants will undergo medical history collection, cardiac auscultation, heart-sound recording, and echocardiography. Echocardiography and expert review will serve as the reference standard. The primary outcome is the sensitivity of each screening approach for detecting CHD that may require clinical intervention or specialist management. The study will also assess detection of all CHD, referral completion, confirmed diagnoses after referral, and related screening outcomes.",[90,91,92,93,94],"Congenital Heart Disease (CHD)","Artifical Intelligence","Screening","Cardiac Auscultation","Primary Care Physician","NOT_YET_RECRUITING","2026-09-16",{"date":98,"type":99},"2026-09-21","ACTUAL",{"date":101,"type":84},"2026-09-14",{"date":103,"type":84},"2027-12-31",{"name":47,"class":6},1]