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Multimodal Assisted Diagnosis for Pediatric Respiratory Diseases Using Questionnaires, Cough Sounds, and Breath Sounds

NCT07613242 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1400

Last updated 2026-05-29

No results posted yet for this study

Summary

This study aims to establish a standardized, synchronized data collection system for pediatric symptom questionnaires, cough sounds, and breath sounds, and to construct a multimodal database of pediatric respiratory diseases including both disease cases and healthy controls. Using the final research labels determined by clinicians' diagnoses, health status assessments, and research team review as the reference standard, this study will develop and validate a multimodal assisted diagnostic model for common pediatric respiratory diseases based on symptom questionnaires, cough sounds, and breath sounds. The study will primarily evaluate the diagnostic performance of the model in distinguishing healthy children from children with respiratory diseases, screening for asthma and asthma-related cough, and identifying pneumonia, tracheitis/bronchitis, upper airway-related diseases, and common causes of chronic cough. It will also assess the incremental value of cough sounds and breath sounds beyond symptom questionnaire information.

Conditions

  • Asthma (Diagnosis)
  • Community-Acquired Pneumonia (CAP)

Interventions

DIAGNOSTIC_TEST

Multimodal respiratory data collection

Participants will complete a structured symptom questionnaire, cough sound recording using a smartphone application, and breath sound recording using an electronic stethoscope. These data will be used to develop and evaluate a multimodal assisted diagnostic model and will not guide real-time clinical decision-making.

Sponsors & Collaborators

  • Shanghai Children's Medical Center

    lead OTHER

Principal Investigators

  • Yong Yin · Shanghai Children's Medical Center

Eligibility

Min Age
28 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-05-01
Completion
2029-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613242 on ClinicalTrials.gov