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NCT07613242

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

Sponsor: Shanghai Children's Medical Center

View on ClinicalTrials.gov

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.

Official title: A Prospective Observational Study of Multimodal Assisted Diagnosis for Pediatric Respiratory Diseases Using Symptom Questionnaires, Cough Sounds, and Breath Sounds

Key Details

Gender

All

Age Range

28 Days - 18 Years

Study Type

OBSERVATIONAL

Enrollment

1400

Start Date

2026-06-01

Completion Date

2029-05-31

Last Updated

2026-05-29

Healthy Volunteers

Yes

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.

Inclusion Criteria: Children aged 28 days to 18 years, regardless of sex, will be eligible for inclusion. The disease group will include children presenting to the outpatient department, emergency department, or inpatient wards of Shanghai Children's Medical Center with cough, wheezing, fever with respiratory symptoms, nasal congestion, rhinorrhea, sore throat, or other respiratory complaints. Participants should be able to complete the symptom questionnaire, cough sound recording, and breath sound recording, and their guardians must provide informed consent and allow review of relevant medical history and diagnostic information. The healthy control group will include children recruited from routine health examinations or children without respiratory complaints, with no acute respiratory symptoms within the past 4 weeks, no known history of chronic respiratory diseases, no obvious respiratory abnormalities on health assessment or research team review, the ability to complete relevant data collection, and guardian informed consent. Exclusion Criteria: Participants will be excluded if they have severe cardiopulmonary malformations, long-term tracheostomy or mechanical ventilation, severe neuromuscular disorders, severe immunodeficiency, or other conditions that may substantially alter cough sound characteristics or affect the clinical presentation of respiratory diseases. Children whose primary diagnosis at the current visit is a non-respiratory disease and who are not suitable for this study will also be excluded. Participants who are unable to complete the symptom questionnaire, or whose cough sound or breath sound recordings remain of insufficient quality after repeated attempts, will not be included or will be excluded from the corresponding modality-specific analysis. Participants with only one unavailable modality may be included in analyses based on the completed modalities but will be excluded from analyses requiring the missing modality. Healthy controls will be excluded from the main control analysis if recent respiratory symptoms, a history of chronic respiratory disease, or other conditions that may affect acoustic features are identified.

Locations (1)

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China