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AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children
Sponsor: Kun Sun
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
0 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
10000
Start Date
2026-09-14
Completion Date
2027-12-31
Last Updated
2026-09-21
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Qinghai Provincial Women and Children's Hospital
Qinghai, Qinghai, China