Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Interest of pre and post surgery EEG on neurodevelopmental disorders
研究概览
简要总结
Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults.
The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients.
On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.
详细描述
Interest of early EEG on congenital cardiopathy surgery to predict the neurodevelopmental disorders occurence.
Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults.
The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients.
On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child of less than 1 year admitted for cardiac surgery on extracorporal circulation on the CHU of Lille during the study period.
- •Child with congenital cardiopathy with necessity to be operated before 1 year old.
排除标准
- •Child with no necessity of surgery before 1 year old.
- •Medical history of cardiac surgery.
- •Refusal of consent by the parents.
- •No social security.
- •Child not operated on the CHU of LILLE.
结局指标
主要结局
Interest of pre and post surgery EEG on neurodevelopmental disorders
时间窗: Age of patient : 24 Months
Evaluation of the interest of pre and post surgery EEG in the prediction of neurodevelopmental disorders on patients operated of congenital cardiopathy before the age of 1 year old.
次要结局
- Association between orality disorders and neurodevelopmental disorders(Age of patient : 24 Months)
- Interest of post surgery EEG neurodevelopmental disorders at 24 months old(Age of patient : 24 Months)