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