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
Trial ID: NCT06791109
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-09-22
Completion date: 2026-01-04
Sponsor: Kun Sun
Collaborators: Bill and Melinda Gates Foundation
Conditions: Congenital Heart Disease (CHD); Screening Tool; Artificial Intelligence (AI); Cluster Randomized Trial; Auscultation for Clinical Evaluation
Interventions: Primary care physicians; AI + Primary care physicians
Locations: Qinghai Provincial Women and Children's Hospital
Countries: China
Enrollment: 19697
Age range: None - 18 Years
Sex: ALL

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 criteria:
Inclusion Criteria (Schools):

* 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.

Exclusion Criteria (Schools):

* More than half of the students in the school refuse to participate in the trial.
* Schools that are unable to complete the study due to severe limitations in geographical location and transportation conditions.
* Schools lacking medical screening facilities and conditions necessary for the implementation of screening.
* Areas where there are no primary healthcare institutions willing to participate in this trial.
* Schools whose management and teaching staff refuse to participate in the study or are unable to cooperate in completing the related screening and data collection work.

Inclusion Criteria (Individuals):

* 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.

Exclusion Criteria (Individuals):

* Individuals over the age of 18.
* Children who are unable to complete echocardiography or do not cooperate with auscultation.
* Participants who are unable to provide informed consent or are unwilling to comply with the study requirements to provide medical data for further analysis and research.
* Participants who have received interventional or surgical treatment for CHD.

Outcomes:
Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians