Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 2
- 主要终点
- Forced expiratory volume
研究概览
简要总结
EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.
详细描述
EPIPAGEADO is a multicenter observational study:- to evaluate respiratory symptoms and lung function at adolescence in very low birthweight (VLBW) children, to identify perinatal risk factors for persistent symptoms or impaired lung function tests at adolescence, to assess the exercise tolerance in VLBW children and to search for genetic susceptibility markers associated to impaired lung function.
The main criteria for analysis will be the forced expiratory volume in one seconde (FEV1) The study duration will be 36 months the number of centers will be 4 centers in France (Paris-Necker, Nantes, Lille, Rouen) The number of patients to be included will be 400, including 260 VLBW children without BPD, 40 VLBW children with BPD, 100 control children with birth at term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Forced expiratory volume
时间窗: Day 0 (at 14 - 15 years old)
Forced expiratory volume in one seconde (FEV1) at 14-15 years
次要结局
- Standardized questionnaire for respiratory symptoms(Day 0 (at 14-15 years old))
- Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)(Day 0 (at 14-15 years old))
- Pulmonary parameters(Day 0 (at 14 - 15 years old))