AI stethoscope vs. Doctor's ear: which finds more heart problems in kids?
NCT ID NCT06791109
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This large study in China compared how well primary care doctors detect congenital heart disease in children using a regular stethoscope versus an AI-assisted electronic stethoscope. Nearly 20,000 children aged 0-18 from schools and kindergartens were screened. The goal was to see if AI help reduces missed diagnoses and expands screening coverage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AI-assisted heart sound analysis
- What this could lead to
- If successful, this could show that AI helps primary care doctors detect more heart defects in children during routine check-ups, potentially leading to earlier treatment.
- What could go wrong
- This is a completed trial, but results are not yet published. The AI may not perform better than specialists, and the findings may not apply outside of China's school screening system.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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19,697 people
The number who actually took part.
- Started
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Sep 2025
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 18 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Qinghai Provincial Women and Children's Hospital
Xining, Qinghai, 810007, China
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