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Can AI help doctors hear hidden heart defects in children?

NCT ID NCT07830251

NEW Diagnosis Sponsor: Kun Sun Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers in Qinghai Province, China, are testing whether artificial intelligence can help primary care doctors spot congenital heart disease during school-based screening. Schools are randomly assigned to either standard listening with a stethoscope or listening plus AI analysis of recorded heart sounds. All children also receive echocardiography, which serves as the reference standard. The trial compares how well each approach detects heart defects that need medical care.

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 cardiac auscultation, where software analyzes recorded heart sounds and advises the doctor
What this could lead to
If AI-assisted listening proves more accurate, schools in remote areas could screen more children for congenital heart disease with the doctors they already have.
What could go wrong
The AI may miss heart defects or raise false alarms, and a screening test alone does not treat anyone. Results from Qinghai schools may not transfer to other settings.

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

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

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

0 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Children and adolescents aged 0-18 years who are enrolled in a participating school in Qinghai Province and are eligible for the school-based congenital heart disease screening program. * Written informed consent provided by the parent or legal guardian, or ethics-approved electronic informed consent, with participant assent obtained when applicable. * Ability to undergo the protocol-specified cardiac auscultation, heart-sound recording, and echocardiographic assessment. * Participant and/or parent or legal guardian is willing to provide the required medical history and, if referral is recommended, follow-up information. Exclusion Criteria: * Inability to cooperate with cardiac auscultation, heart-sound recording, or echocardiography, when the required procedure cannot be completed after reasonable attempts. * Known congenital heart disease previously treated with catheter-based intervention or cardiac surgery, when the primary endpoint is not applicable under the protocol. * Any condition that prevents completion of the required study procedures or prevents obtaining an interpretable protocol-specified echocardiographic assessment. * Informed consent or assent is not provided, or consent is withdrawn before completion of the study procedures.

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Artifical intelligence Cardiac auscultation Congenital heart disease (CHD) Primary care physician Screening

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Qinghai Provincial Women and Children's Hospital

    Qinghai, Qinghai, China

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