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临床试验/NCT06352944
NCT06352944尚未招募不适用

Bronchoscopic Derived Bronchoalveolar Lavage Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children

Assiut University0 个研究点目标入组 30 人开始时间: 2024年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children

研究概览

简要总结

The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity )

详细描述

• The severity of bronchiectasis will be assessed using forced expiratory volume in 1s (FEV1), and bronchiectasis severity scores which included bronchiectasis severity index (BSI) , FEV1, chronic colonization, extension of lobes and dyspnea which were performed to assess non-CF bronchiectasis patients.

BSI score

  • This score incorporates 9 variables. The total score is calculated by summing the scores for each variable and can range from 0 to 26 points. According to the overall score, patients are classified into three classes: patients with low BSI score (0---4 points), intermediate BSI score (5---8 points), high BSI score (≥9 points)
  • chest X ray and HRCT of the chest: to assess the radiological severity of bronchiectasis using the radiological findings will be measured by assessing the most recent chest X ray and HRCT of the chest performed in the last six months using Bhalla score(10)
  • Culture and sensitivity from bronchoalveolar lavage for isolation of pseudomonas aeruginosa and any other organism.
  • Sputum procalcitonin level was measured in BAL samples using bronchoscopy.
  • Bronchoscopy: would be undertaken when the children were in a stable clinical condition as part of their annual review

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Children of both sex
  • Children aged from 6-17 years old.
  • Documented diagnosis of non-CF bronchiectasis by confirmed bronchiectasis findings using high-resolution computed tomographic (HRCT) lung scanning, and clinical symptoms consistent with bronchiectasis with a negative sweat test

排除标准

  • Age less than 6 years or more than 17 years.
  • Children Diagnosed with cystic fibrosis bronchiectasis with confirmed positive sweat chloride test(6).
  • If there was a history of a recent exacerbation during the previous month preceding the study.

结局指标

主要结局

procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children

时间窗: 2 years

comparison between procalcitonin level in Bronchoalveolar lavage and other markers of severity of bronchiectasis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maram Mohamed Amir Fathy

assistant lecturer

Assiut University

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