Body Voice AI for Childhood Heart and Lung Health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, cross-sectional study collects real-world heart, breathing, and bowel sounds from children to train a deep learning model that can distinguish normal from abnormal sounds. The team will annotate and extract relevant features, build a multimodal AI algorithm, and compare AI outputs with standard diagnostic results such as echocardiograms and chest/abdominal imaging using metrics like AUC, sensitivity, and specificity. External validation will use data from additional sites to assess generalizability. The goal is an intelligent auscultation tool for early screening and supportive diagnosis of congenital heart disease, respiratory infections, diarrhea, and related conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 0\~18 years old, gender is not limited
2. Children who have been diagnosed with congenital heart disease by cardiac ultrasound or who do not have congenital heart disease
3. Children diagnosed with bronchopneumonia or without bronchopneumonia
4. Children who are clinically diagnosed with intestinal diseases or who do not suffer from intestinal diseases
5. Informed consent

Exclusion Criteria:

1. ≥ 18 years old
2. Children who are unable to undergo cardiac ultrasound, chest imaging or other related examinations
3. Subjects who are unable to obtain informed consent, or who are unwilling to cooperate with the provision of diagnosis and treatment related data for further analysis and research as required by the study.

Where it's running

• Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Human Children's Hospital
  Changsha, Hunan, China Recruiting
• Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Kunming children's Hospital
  Kunming, Yunnan, China Recruiting

Study contacts

• Principal investigator: Xin Sun, MD — Xinhua Hospital, Shanghai J iao Tong University School of Medicine
• Study coordinator: Xin Sun, MD
• Email: sunxin@xinhuamed.com.cn
• Phone: 0086-021-25077480

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.