Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 21
- 主要终点
- Child IQ as measured by the Differential Abilities Scale at 6 Years of age
研究概览
简要总结
The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?
详细描述
This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 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
Child IQ as measured by the Differential Abilities Scale at 6 Years of age
时间窗: 6 years
次要结局
- Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale(6 Years)
- Behavior via Behavior Assessment for Children & Parent Stress Index(6 Years)
- Academic Functioning via Wide Range Achievement Test(6 Years)
- Executive Functioning,Tower-NEPSY(6 Years)
- Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales(6 Years)
- Motor Functioning via Grooved Pegboard(6 Years)
- Memory via Children's Memory Scale(6 Years)
- Adaptive Functioning via Adaptive Behavior System -2nd Edition(6 Years)
研究者
Kimford J. Meador, MD
Professor
Emory University