Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- chloride concentration
研究概览
简要总结
In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. In children between 3 and 12 months, this rate is about 10% when it should not exceed 5%. Insufficient amount of sweat prevents confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before irreversible complications of the disease.
In this trial, a new support of sweat collection (Macroduct® Advanced Model 3710 Sweat Collection System, Wescor) will be tested with the goal to increase the amount of sweat collected during the sweat test, in comparison with the clinical routine method.
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
- 2 Days 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged of 2 days to 12 months
- •Indication of a sweat test prescribed by a clinician in a context of neonatal screening
- •Clinically stable
- •Well hydrated
- •Not under treatment with mineralocorticoids
排除标准
- •Subjects weighing less than 2 kg
- •Subjects less than 48 hours old
- •Presence of an acute infectious condition
- •Presence of mineralocorticoid treatment
研究组 & 干预措施
one group : patients with suspicion of cystic fibrosis
干预措施: Macroduct® Advanced Model 3710 SYS, Wescor (Device)
结局指标
主要结局
chloride concentration
时间窗: day 1
The volume and the chloride concentration will be analyzed for each subject.
次要结局
- sweat(day 1)