Respiratory Function at Preschool Age of Children Detected of Cystic Fibrosis in Neonatal Period (REVOLMUCO)
The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Standard respiratory function criteria for older children and adults is forced expiratory volume/second.
This technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second.
For preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic measure of specific resistance (sRaw), functional residual capacity by Helium dilution technique (CRF He), arterial blood gas measurement, pulmonary clearance index.
All these methods have a better success rate and can be used in alternative or with forced spirometry. However, each of them gives only a part of information on airway and lung damage of detected children. It is necessary to combine them for a better information on overall respiratory damage.
In France, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment.
So, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers.
A referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. And, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Montpellier、法国、34295
- University Hospital of Montpellier, Arnaud de Villeneuve
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient suffering from cystic fibrosis
- Height between 90 et 130cm
- No respiratory exacerbation since 4 weeks
- Benefit from an insurance disease regime
Exclusion Criteria:
- Law-protected patient
- Patient's parent don't understand french language
- Opposition to participation
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Preschool aged children detected of CF in neonatal period
Preschool aged children detected of Cystic Fibrosis in neonatal period
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Time evolution of functional residual capacity by Helium dilution technique (CRF He)
大体时间:at each four yearly routine visits
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at each four yearly routine visits
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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airway resistance by debit interruption technique (Rint)
大体时间:at each four yearly routine visits
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at each four yearly routine visits
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plethysmographic measure of specific resistance (sRaw)
大体时间:at each four yearly routine visits
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at each four yearly routine visits
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arterial blood gas measurement
大体时间:at each four yearly routine visits
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at each four yearly routine visits
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pulmonary clearance index
大体时间:at each four yearly routine visits
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at each four yearly routine visits
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flow-volume curve
大体时间:at each four yearly routine visits
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at each four yearly routine visits
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measurement of organ damage
大体时间:at each four yearly routine visits
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at each four yearly routine visits
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measurement of tobacco exposition
大体时间:at each four yearly routine visits
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at each four yearly routine visits
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measure of administration antibiotics and antiasthmatics treatments
大体时间:at each four yearly routine visits
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Comparison of the evolution of these parameters to changing those of a historical cohort evaluated before the introduction of neonatal screening.
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at each four yearly routine visits
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合作者和调查者
调查人员
- 首席研究员:MATECKI SM Stephan, MD、University Hospital, Montpellier
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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