Neurodevelopment Effects of Antiepileptic Drugs

描述(由申请人提供)：这项赠款申请是为数据和统计协调中心提出的，以支持正在进行的NEAD研究的继续，该研究解决了妇女及其子女的一个重要卫生保健问题。在患有癫痫和其他适应症的育龄妇女中，使用抗癫痫药物是很常见的。动物研究清楚地表明，常用的抗癫痫药物会损害行为神经发育。人类这种认知和行为缺陷的潜在后果在个人和社会成本方面都是严重的。然而，在这个问题上存在争议，这项提案将解决这一问题。NEAD研究的主要目的是区分四种最常用的抗癫痫药物在女性癫痫治疗中的相对风险/益处，根据她们的孩子在宫内接触AED单一疗法(卡马西平、拉莫三嗪、苯妥英或丙戊酸盐)后的神经行为发育。NEAD研究是一项前瞻性、平行组、队列设计、多中心调查。NEAD研究的主要优势在于，它招募了331对怀孕期间独特的母亲和孩子，并收集了可能影响神经行为结果的因素的前瞻性数据。主要的结果变量是6岁/岁时儿童的智商分数和其他神经行为发育指标。注册是通过25个国内站点的参与和最近在英格兰增加的站点实现的。这笔赠款将为整个NEAD研究网络提供所需的统计和数据管理支持。它将支持延长临床资助，旨在跟踪儿童到6岁/岁，届时神经行为测量预测学校表现和最终成人智商。NEAD研究有一个非常宝贵的队列，这项延续建议的结果将影响接受这些药物的妇女的临床管理，并改善她们孩子的健康。DSCC将促进这一努力的及时性和质量。

DESCRIPTION (provided by applicant): This grant application is for the Data and Statistical Coordinating Center proposed to support the continuation of the ongoing NEAD study, which addresses an important health care issue for women and their children. The use of antiepileptic drugs (AEDs) in women of childbearing age for epilepsy and for other indications is common. Animal studies clearly demonstrate that commonly employed AEDs impair behavioral neurodevelopment. The potential consequences of such cognitive and behavioral deficits in humans are severe in terms of both personal and societal costs. However, controversy exists on this issue and will be addressed by this proposal. The primary objective of the NEAD study is to differentiate the relative risks/benefits of the four most commonly used AEDs in the treatment of women with epilepsy, in terms of their children's neurobehavioral development after in utero exposure to AED monotherapy (carbamazepine, lamotrigine, phenytoin, or valproate). The NEAD study is a prospective, parallel-group, cohort design, multicenter investigation. The major strength of the NEAD study is that it has enrolled a large and unique cohort of 331 mother/child pairs during pregnancy and collected prospective data on factors that could affect neurobehavioral outcome. The primary outcome variables are IQ scores of the children and other measures of neurobehavioral development at 6 years/old. Enrollment was achieved through the participation of 25 domestic sites and the recent addition of sites in England. This grant will provide the required statistical and data management support to the entire NEAD study network. It will support the extension of the clinical `grant, designed to follow the children to 6 years/old, at which time neurobehavioral measures predict school performance and ultimate adult IQ. The NEAD study has an invaluable cohort, and the results of this continuation proposal will impact the clinical management of women receiving these medications and improve the health of their children. The DSCC will facilitate the timeliness and quality of this endeavor.