An observational study in Chronic Cough (CC), sponsored by Shanghai Children's Medical Center. Not yet recruiting at 1 site in China. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Shanghai Children's Medical Center · Observational
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.
Development of a Wenjuanxing-based multidimensional etiologic screening questionnaire for pediatric chronic cough This study aims to develop and validate a structured, parent-reported, electronic questionnaire for multidimensional etiologic screening of chronic cough in children, based on current clinical practice guidelines and expert consensus. The questionnaire is designed and deployed on the Wenjuanxing platform and focuses on standardized, comprehensive, and reproducible symptom collection.
The questionnaire includes multiple domains: cough duration and temporal pattern (daytime vs nocturnal cough), cough characteristics (dry vs wet), triggering factors (exercise, cold air, allergen exposure), associated respiratory and extra-respiratory symptoms (wheezing, nasal congestion, postnasal drip, throat clearing, gastroesophageal reflux symptoms), past medical history, family history, and environmental exposures. Logical branching and rule-based algorithms are embedded to automatically generate preliminary etiologic suggestions, including cough variant asthma (CVA), upper airway cough syndrome (UACS), protracted bacterial bronchitis (PBB), post-infectious cough (PIC), eosinophilic bronchitis (EB), and gastroesophageal reflux-related cough (GERC).
The electronic format allows standardized data acquisition, real-time logic checking, automated output of etiologic suggestions, and efficient data export for subsequent clinical evaluation and statistical analysis.
Clinical validation of the questionnaire in routine outpatient practice This is a prospective, controlled, observational study conducted in the pediatric respiratory outpatient clinic of Shanghai Children's Medical Center. Children aged 3-18 years presenting with cough lasting ≥2 weeks and meeting the inclusion criteria will be consecutively enrolled after informed consent is obtained from their caregivers.
All caregivers will complete the Wenjuanxing questionnaire. Participants will be assigned to one of two parallel groups according to the study protocol: a routine-care group, in which physicians perform diagnosis and treatment based on standard clinical assessment without access to questionnaire results; a questionnaire-assisted group, in which physicians review the questionnaire-generated etiologic suggestions before making diagnostic and therapeutic decisions.
At the initial visit, physicians will record their clinical diagnosis and treatment plan. In the questionnaire-assisted group, physicians will additionally rate the perceived usefulness of the questionnaire and their level of confidence in the questionnaire's etiologic suggestions using standardized numeric scales.
If symptom improvement is insufficient, further guidance and an additional follow-up may be conducted according to the study protocol. The primary outcome is the difference in diagnostic accuracy between the routine-care group and the questionnaire-assisted group, with follow-up response serving as post-hoc clinical validation. Secondary outcomes include treatment effectiveness, caregiver satisfaction, physician acceptance, and feasibility of implementing the questionnaire in real-world outpatient settings.
This study aims to establish a scalable, digital, and standardized screening approach for pediatric chronic cough, supporting early etiologic identification and improving clinical decision-making in routine practice.
140 studies on the registry are indexed under Chronic Cough; 37 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 33 observational studies indexed under Chronic Cough.
Browse Chronic Cough studies →Shanghai Children's Medical Center is the lead sponsor of 37 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Physician-Blinded to Questionnaire Results
Other: No intervention (observational study)
Physician-Informed by Questionnaire Results
Other: No intervention (observational study)
No intervention (observational study)
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.
Time frame: Approximately 2 weeks after the initial outpatient visit
Plan to share: Undecided
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Children's Medical Center