AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children

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.