Evaluation of Lung Clearance Index for Early Detection of Lung Disease in Young Children With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- measure of nitrogen washout and Brody 2 score
研究概览
简要总结
The purpose of this study is to determine the efficacy of a non invasive method of detecting the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as possible.
Moreover this screening procedure permits to note the improvement following the treatment and to choose the optimal treatment in term of efficacy.
详细描述
It is mandatory to detect as early as possible lung CF disease in the young child with CF to initiate active therapies limiting irreversible lesions. Lung Clearance Index (LCI) which evaluates gas clearance from the alveolar volume is an easy to-do technique in pre-school children.
Main objective To evaluate correlation between LCI and thoracic low dose computed tomodensitometry (CT) endpoints at initial visit Secondary objectives
- To evaluate correlation between LCI and respiratory function measurements at each visit
- To evaluate correlation between the evolution of LCI and respiratory function endpoints and the evolution of CT only for the children for whom a thoracic low dose CT is requested by their referent doctor after two years.
- To evaluate LCI predictive value for respiratory function 2 years later in preschool children.
This is a prospective multicenter cohort study. Study visits will be performed each year during the annual check up for normal follow up of the child.
Initial visit (Visit 1) takes place during an annual check-up during which a low dose CT was prescribed. It will include following tests: LCI, Lung function tests (LFTs) performed according to age (forced volumes and flows, plethysmographic specific airway resistances and interrupter resistances), and a low dose CT scan performed according a standardized protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with typical cystic fibrosis (sweat chloride level >60 mEq/l) followed in reference centre participating to the study
- •From 3 to 6 years old
- •Children with a planned annual assessment that required thoracic computed tomography and lung function test
- •Children with informed and non opposed parents
排除标准
- •Children with atypical cystic fibrosis
- •Children with bronchial exacerbation dating less than 2 weeks
- •Children with severe associated disease
研究组 & 干预措施
LCI
Measure of lung clearance index
干预措施: Lung clearance index determination (Other)
结局指标
主要结局
measure of nitrogen washout and Brody 2 score
时间窗: Month 0
次要结局
- measure of FEV (Correlation between the evolution of LCI and respiratory function endpoints and CT)(2 years)
- measure of FEV (Evaluation of LCI predictive value for respiratory function in preschool children)(2 years)