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Respiratory Function at Preschool Age of Children Detected of Cystic Fibrosis in Neonatal Period (REVOLMUCO)

2020年4月9日 更新者:University Hospital, Montpellier

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

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Montpellier、法国、34295
        • University Hospital of Montpellier, Arnaud de Villeneuve

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

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

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Preschool aged children detected of CF in neonatal period
Preschool aged children detected of Cystic Fibrosis in neonatal period

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Time evolution of functional residual capacity by Helium dilution technique (CRF He)
大体时间:at each four yearly routine visits
at each four yearly routine visits

次要结果测量

结果测量
措施说明
大体时间
airway resistance by debit interruption technique (Rint)
大体时间:at each four yearly routine visits
at each four yearly routine visits
plethysmographic measure of specific resistance (sRaw)
大体时间:at each four yearly routine visits
at each four yearly routine visits
arterial blood gas measurement
大体时间:at each four yearly routine visits
at each four yearly routine visits
pulmonary clearance index
大体时间:at each four yearly routine visits
at each four yearly routine visits
flow-volume curve
大体时间:at each four yearly routine visits
at each four yearly routine visits
measurement of organ damage
大体时间:at each four yearly routine visits
at each four yearly routine visits
measurement of tobacco exposition
大体时间:at each four yearly routine visits
at each four yearly routine visits
measure of administration antibiotics and antiasthmatics treatments
大体时间:at each four yearly routine visits
Comparison of the evolution of these parameters to changing those of a historical cohort evaluated before the introduction of neonatal screening.
at each four yearly routine visits

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:MATECKI SM Stephan, MD、University Hospital, Montpellier

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年8月19日

初级完成 (实际的)

2020年1月17日

研究完成 (实际的)

2020年1月17日

研究注册日期

首次提交

2015年1月21日

首先提交符合 QC 标准的

2015年2月3日

首次发布 (估计)

2015年2月9日

研究记录更新

最后更新发布 (实际的)

2020年4月14日

上次提交的符合 QC 标准的更新

2020年4月9日

最后验证

2020年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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