Research on Body Voice AI Recognition System for Children's Health Management

NCT06542120 | Not Yet Recruiting DMC

• 1 other identifier: XH-24-005
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this research is to develop a body voice artificial intelligence (AI) recognition device, also referred to as an AI-assisted body sound identification device, by utilizing a deep learning-based novel AI algorithm in conjunction with a big body voice model. It could identify normal and abnormal heart, breath, and bowel sounds, and to provide early screening and auxiliary diagnosis of congenital heart disease (CHD), respiratory infections, diarrhea and other common multi-occurring diseases.

Conditions

Congenital Heart Disease; Bronchopneumonia; Abdominal Disease

Outcome Measures

Primary Outcomes (3)

• Sensitivity

  Sensitivity in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation

  1 month

• Specificity

  Specificity in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation

  1 month

• AUC

  AUC in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation

  1 month

Study Arms (1)

0 ~ 18 years old children

Age range: 0 to 18 years old, with no gender restriction. Children who have been diagnosed with congenital heart disease (CHD) or confirmed to be free of CHD through echocardiographic examinations. Children who have been diagnosed with bronchopneumonia or confirmed to be free of bronchopneumonia through chest imaging examinations. Children who have been diagnosed with abdominal diseases or confirmed to be free of abdominal diseases through abdominal imaging examinations.

Diagnostic Test: Heart Auscultation and Echocardiography; Diagnostic Test: Chest Auscultation and Chest imaging examinations; Diagnostic Test: Abdominal Auscultation and Abdominal imaging examinations

Interventions

Heart Auscultation and Echocardiography DIAGNOSTIC_TEST

Heart auscultation will be done by pediatrician and echocardiography by echocardiologist

0 ~ 18 years old children

Chest Auscultation and Chest imaging examinations DIAGNOSTIC_TEST

Chest auscultation will be done by pediatrician and chest imaging examinations by radiologist

0 ~ 18 years old children

Abdominal Auscultation and Abdominal imaging examinations DIAGNOSTIC_TEST

Abdominal auscultation will be done by pediatrician and chest imaging examinations by radiologist

0 ~ 18 years old children

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. Children (0-18 years old) with congenital heart disease confirmed by cardiac ultrasound and children without congenital heart disease confirmed by cardiac ultrasound. 2. Children (0-18 years old) with bronchopneumonia confirmed by chest imaging examination and children without bronchopneumonia confirmed by imaging. 3. Children (0-18 years old) with abdominal imaging confirmed abdominal disease and children diagnosed without abdominal disease by imaging.

You may qualify if:

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

You may not qualify if:

• ≥ 18 years old
• Children who are unable to undergo cardiac ultrasound, chest imaging or other related examinations
• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (5)

Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430016, China

Location

Human Children's Hospital

Changsha, Hunan, 410007, China

Location

Xinhua Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Kunming children's Hospital

Kunming, Yunnan, 650028, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Bronchopneumonia

Interventions

Heart Auscultation; Echocardiography

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pneumonia; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Auscultation; Physical Examination; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Officials

• Xin Sun, MD

  Xinhua Hospital, Shanghai J iao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Sun, MD

CONTACT

0086-021-25077480; sunxin@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 7, 2024
• Study Start: August 21, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 30, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-04

Locations

CN (5)