Cerebral Abnormalities Detected by MRI, Realized at the Age of Term and the Emergence of Executive Functions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 25
- 主要终点
- Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
研究概览
简要总结
The survival of premature babies increased during the last decades. However, the neurocognitive long term development of these children is worrying, as demonstrated by EPIPAGE 1 study.
These children present high risk of deficits such as cognitive deficits, adaptive malfunction, behavior disorders and difficulties in school learning.
Understanding the specific neuropsychological disorders at the origin of these deficits is an important objective. Studies realized at school age showed that many premature children have executive functions (EF) disorders. However the specific nature of these disorders and the neuropathology associated are unknown.
The aim of this study is to realise MRI at term age in preterm babies born less than 32 GA and to correlate MRI findings with executives functions and neurodevelopmental outcome
详细描述
An MRI would be realized between 39 and 41 GA
At the age of 5 years, executive functions and neurodevelopmental testing would be realized.
600 newborns were recruited.
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
- 25 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who were :
- •born between 25 and 32 WGA
- •hospitalized in a neonatology service which participate to the present study
- •included in EPIPAGE 2 follow-up study
- •infants whose parents had signed the consent agreement and benefit from national health insurance
排除标准
- •Infants with congenital abnormalities
研究组 & 干预措施
MRI assessment
干预措施: term MRI, executive EF functions testing (Procedure)
结局指标
主要结局
Executive functions evaluation at age of 5 and comparison with conventionnal and advanced MRI imagings
时间窗: During the 5 years follow up
次要结局
- Perinatal risk factors and cerebral lesions as assessed on MRI(During the 5 years follow up)
- Perinatal risk factors and executive and cognitive functions evaluated at 5 years of age(During the 5 years follow up)