AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children
Key facts
- Where
- Qinghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 18 years old?
Source: NCT07830251, who can take part
Where in China
- Qinghai Provincial Women and Children's HospitalQinghai, ChinaContact: Liudan ZhaoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Kun Sun
- Trial code
- NCT07830251
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Eligible 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.
Participants 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.
Inclusion: 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; Written informed consent provided by the parent or legal guardian, or ethics-approved electronic informed consent, with participant assent obtained when applicable; Ability to undergo the protocol-specified cardiac auscultation, heart-sound recording, and echocardiographic assessment; Participant and/or parent or legal guardian is willing to provide the required medical history and, if referral is recommended, follow-up information.
Exclusion: Known congenital heart disease previously treated with catheter-based intervention or cardiac surgery, when the primary endpoint is not applicable under the protocol; Inability to cooperate with cardiac auscultation, heart-sound recording, or echocardiography, when the required procedure cannot be completed after reasonable attempts; Any condition that prevents completion of the required study procedures or prevents obtaining an interpretable protocol-specified echocardiographic assessment; Informed consent or assent is not provided, or consent is withdrawn before completion of the study procedures.