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

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention (observational study): No intervention (observational study)

Study 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.

Eligibility

Primary outcome measure(s)

• Diagnostic Accuracy of Initial Etiologic Assessment for Pediatric Chronic Cough — Approximately 2 weeks after the initial outpatient visit
  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.

Trial sites (1)

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