NCT04298346已完成不适用
GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Identify a polymorphism associated with the risk of developing cerebral palsy at 2 years in a regional population of premature infants of gestational age <34 weeks gestation.
研究概览
简要总结
This study could help identify aggravating or protective genetic polymorphisms associated with cerebral palsy. Populations of premature babies at different risk of cerebral palsy could thus be individualized with an impact on their monitoring and on the pathophysiological understanding of the processes leading to neurological lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children born prematurely at term <34 weeks between 2008 and 2015
- •assessed at the age of 2 within the Growing Together Network in Pays de Loire
- •parental consent for the collection of data from their child and for intraoral sampling for the search for genetic factors.
排除标准
- •children who died after the age of 2
- •children who refused and / or whose parents refused to participate in the study
结局指标
主要结局
Identify a polymorphism associated with the risk of developing cerebral palsy at 2 years in a regional population of premature infants of gestational age <34 weeks gestation.
时间窗: 2 years
frequency of variants within the case and control groups using the statistical criterion "level of significance" (also called p-value and known by the English word "p-value") of 5.10-8
次要结局
- Identify a specific polymorphism of certain forms of cerebral palsy(2 years)
- Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.(2 years)
研究者
研究点 (1)
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