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AI reads chest X-Rays to catch kawasaki disease earlier in kids

NCT ID NCT07405658

Diagnosis Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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.
By invitation only
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test whether an artificial intelligence system can spot signs of Kawasaki disease in children's chest X-rays earlier than standard methods. Researchers will analyze data from 20,000 children to see if the AI can predict the best time for treatment and reduce heart risks. The goal is to create a faster, more accurate way to diagnose this serious childhood illness.

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.

Participants

About 20,000 people

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

Expected to start

Feb 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.

Who is studied

The case group consists of children diagnosed with Kawasaki Disease (KD) over the past 10 years. The inclusion criteria include: Children diagnosed with Kawasaki Disease based on clinical symptoms and confirmed by medical records. The control group consists of data from patients with fever lasting ≥3 days, matched to the KD cohort based on diagnosis year, month, and clinical characteristics. The study focuses on examining the relationship between chest X-ray features and Kawasaki Disease in these patients.

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: 1. Case group * The age of seeking medical treatment is less than or equal to 18 years old; ·The medical record system diagnosis contains the diagnosis of "Kawasaki Disease", "mucocutaneous lymph node syndrome" or "IVIG non-response Kawasaki disease" * At least one complete chest X-ray examination data (images and reports) is available during the same hospitalization 2. Control group * The age of seeking medical treatment is less than or equal to 18 years old * The same period as the case group * Fever lasts for 3 days or more * Rule out the possibility of diagnosing Kawasaki disease Exclusion Criteria: 1. Case group * Chest X-ray quality issues: Severe artifacts, overexposure/underexposure leading to inability to assess key structures * Incomplete clinical information, including lack of chest X-ray examination, laboratory tests, and unclear days of fever Inability to determine the final diagnosis (such as loss to follow-up, diagnosis in doubt) 2. Control group * Chest X-ray quality issues: Severe artifacts, overexposure/underexposure leading to inability to assess key structures * Incomplete clinical information, including lack of chest X-ray examination, laboratory tests, and unclear days of fever * Inability to make a clear final diagnosis (such as loss to follow-up, questionable diagnosis)

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Conditions

The condition(s) this trial relates to.

Kawasaki disease

As listed by the trial registrant

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

Chest X-ray for clinical evaluation Kawasaki disease Mucocutaneous lymph node syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 2000000, China

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