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临床试验/NCT02883816
NCT02883816已完成不适用

Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2008年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Change from respiratory function at 7 months and 11 months

研究概览

简要总结

The main objective of this study is to show that there is a concordance between lung disease at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis asymptomatically.

This will identify at the first examination at 8 weeks, newborns who have the most impaired lung function at 13 months. To meet this objective an assessment of their lung function at 9 weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
8 Weeks 至 14 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infant aged 11 weeks

排除标准

  • Gestational age lower than 35 weeks of gestation,
  • Background invasive mechanical ventilation in positive pressure
  • Documented -Obstructive Sleep Apnea, heart defect, neuromuscular disease

研究组 & 干预措施

cystic fibrosis

Experimental

assessment of lung function in newborns screened for cystic fibrosis

干预措施: assessment of lung function (Other)

结局指标

主要结局

Change from respiratory function at 7 months and 11 months

时间窗: 7 months and 11 months

measurement of lung volumes and flow rates of bronchial

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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