Efficacy Comparison Between Independent Auscultation by Primary Care Physicians and AI-Assisted Auscultation in Large-scale Screening for Congenital Heart Disease: A Cluster Randomized Controlled Trial in China

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study plans to conduct clinical validation of the model in real clinical settings, comparing it with primary care physicians and specialist physicians to ensure the model's practicality. Through continuous optimization and practice, the study aims to use AI-assisted heart sound auscultation to empower the auscultation capabilities of primary care obstetricians, pediatricians, and non-cardiovascular specialists nationwide. This will not only reduce the missed diagnosis rate and improve the detection rate of existing CHD screenings, but also expand the coverage of current CHD screening networks, incorporating newborns, infants, preschool children, children, and adolescents aged 0-18 years into the screening scope. The study aims to establish a new benchmark in child health management by providing feasible and cost-effective child health management solutions for other developing countries, contributing to global efforts for the health of children.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: t
View:

• The school is of the type: kindergarten, primary school, junior high school, or senior high school.

• The school has medical screening facilities and conditions that can support AI-assisted screening.

• The area where the school is located has at least one primary healthcare institution willing to participate in this trial.

• The school's management and teaching staff are willing to participate in the study and can cooperate to complete the related screening and data collection work.

• Children aged between 0 and 18 years, regardless of gender.

• Children who agree to undergo echocardiography to determine the presence of congenital heart disease.

• Individuals who voluntarily participate in this study and sign the informed consent form.

Locations
Other Locations
China
Qinghai Provincial Women and Children's Hospital
RECRUITING
Xining
Contact Information
Primary
Kun Sun, Phd
drsunkun@xinhuamed.com.cn
021-13601846338
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2026-02-22
Participants
Target number of participants: 28833
Treatments
Active_comparator: Primary care physicians
Experimental: AI + Primary care physicians
Related Therapeutic Areas
Sponsors
Collaborators: Bill and Melinda Gates Foundation
Leads: Kun Sun

This content was sourced from clinicaltrials.gov