Wenjuanxing-Based Multidimensional Etiologic Screening and Clinical Validation of Chronic Cough in Children

NCT07306637 | Not Yet Recruiting DMC

• 1 other identifier: SCMCIRB-YJ2025012
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic cough is a common and burdensome condition in children, with complex and overlapping etiologies that often lead to delayed diagnosis, misdiagnosis, and inappropriate treatment. This prospective, controlled, observational study aims to develop and clinically validate a Wenjuanxing-based, parent-reported, multidimensional etiologic screening questionnaire for pediatric chronic cough. Children aged 3-18 years presenting with cough lasting ≥2 weeks will be enrolled in a tertiary pediatric respiratory clinic and allocated to either a routine-care group or a questionnaire-assisted group. All caregivers will complete the standardized electronic questionnaire, which generates an automated preliminary etiologic suggestion based on symptom patterns, triggers, and associated features. Diagnostic accuracy, treatment effectiveness, and symptom resolution will be evaluated through structured follow-up at two weeks. The primary outcome is the difference in diagnostic accuracy between physicians using routine assessment alone and those supported by the questionnaire. Secondary outcomes include treatment response and prevention of cough chronicity. This study seeks to provide evidence for a scalable, digital, and standardized screening tool to improve early etiologic identification and clinical decision-making in pediatric chronic cough.

Conditions

Chronic Cough (CC)

Keywords

Pediatric; chronic cough; Etiologic Screening; Electronic Questionnaire

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Initial Etiologic Assessment for Pediatric Chronic Cough

  Diagnostic accuracy is defined as the concordance between the initial etiologic diagnosis made at the first outpatient visit and the post hoc clinical validation based on symptom response during follow-up. Caregivers will be contacted approximately two weeks after the initial visit and asked to report changes in cough symptoms using a standardized follow-up protocol. An initial diagnosis will be considered correct if the prescribed treatment results in marked improvement or resolution of cough symptoms, as assessed by caregiver-reported symptom improvement and overall treatment effectiveness. The diagnostic accuracy will be compared between the routine-care group and the questionnaire-assisted group.

  Approximately 2 weeks after the initial outpatient visit

Study Arms (2)

Routine Care

Physician-Blinded to Questionnaire Results

Other: No intervention (observational study)

Questionnaire-Assisted Care

Physician-Informed by Questionnaire Results

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Questionnaire-Assisted Care; Routine Care

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 3 to 18 years presenting to the pediatric respiratory outpatient clinic of Shanghai Children's Medical Center with cough lasting at least 2 weeks will be eligible for enrollment. The study population consists of symptomatic pediatric patients without fever in the preceding two weeks, whose caregivers are willing to complete an electronic questionnaire and participate in follow-up assessments. Participants will receive routine clinical evaluation and management according to standard practice, with or without access to questionnaire-generated etiologic suggestions, depending on study group assignment.

You may qualify if:

• Children aged 3 to 18 years, any sex.
• Presenting for medical care due to cough lasting ≥2 weeks.
• No fever within the past 2 weeks.
• Caregiver is willing to complete the Wenjuanxing questionnaire and agree to follow-up.

You may not qualify if:

• Presence of congenital airway malformations, chronic lung disease, or severe immunodeficiency.
• Recent participation in other interventional clinical research.
• Unable to complete follow-up as required.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Chronic Cough

Interventions

Observation

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Yong Yin, PhD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yin, PhD

CONTACT

8618930830705; yinyong9999@163.com

Study Design

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

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CN (1)