Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Existence of abnormalities
研究概览
简要总结
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs.
There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia.
The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.
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
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full-term children, gestational age> 36 weeks of amenorrhea
- •Between the 1st of January 2012 and the 31st of December 2016
- •Hospitalized in the neonatal resuscitation department of Croix Rousse in Lyon
- •Perinatal asphyxia with clinical signs of encephalopathy
- •Indication of therapeutic hypothermia not retained because EAI mild
- •Where parents were informed and did not object to participation in the study
排除标准
- •Dysmorphic syndrome
- •Children transferred for other criteria (respiratory distress, heart failure ...)
结局指标
主要结局
Existence of abnormalities
时间窗: maximum 1 years
Abnormalities researched are : abnormal motor, sensory (auditory or visual), delayed psychomotor acquisition compared to the expected (norms), or epilepsy at 2 years. These anomalies will be collected by sending a questionnaire to the parents.
次要结局
未报告次要终点