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临床试验/NCT07306637
NCT07306637尚未招募不适用

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

Shanghai Children's Medical Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
Diagnostic Accuracy of Initial Etiologic Assessment for Pediatric Chronic Cough

研究概览

简要总结

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.

详细描述

  1. 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. 2. 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. 3. Follow-up and outcome assessment All enrolled patients will be followed up approximately two weeks after the initial visit via telephone or online contact using a standardized operating procedure. Caregivers will be asked to report changes in cough symptoms, including degree of improvement, time to symptom relief, and overall treatment effectiveness. Caregivers will also rate the perceived consistency between the questionnaire-based etiologic suggestion and the physician's final diagnosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Diagnostic Accuracy of Initial Etiologic Assessment for Pediatric Chronic Cough

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Shanghai Children's Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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