Neurodevelopment Effects of Antiepileptic Drugs

抗癫痫药物对神经发育的影响

• 批准号: 6951190
• 负责人: MARK C WOLFF
• 金额: $ 48.35万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-25 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6951190
• 关键词: anticonvulsants; behavioral /social science research tag; carbamazepine; child behavior disorders; children; clinical research; comorbidity; developmental neurobiology; embryo /fetus drug adverse effect; epilepsy; female; human subject; human therapy evaluation; intelligence tests; longitudinal human study; neuropsychology; outcomes research; parents; patient oriented research; phenytoin; questionnaires; socioeconomics; valproate

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.

描述（由申请人提供）：本补助金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重要医疗保健问题。抗癫痫药物（AED）在育龄妇女中用于癫痫和其他适应症是常见的。动物研究清楚地表明，常用的AED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，本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AED在治疗癫痫女性中的相对风险/获益，在子宫内暴露于AED单药治疗（卡马西平、拉莫三嗪、苯妥英或丙戊酸盐）后儿童的神经行为发育方面。NEAD研究是一项前瞻性、平行组、队列设计、多中心研究。NEAD研究的主要优势在于它招募了一个由331对怀孕期间的母亲/儿童组成的大型独特队列，并收集了可能影响神经行为结果的因素的前瞻性数据。主要结果变量是儿童的智商分数和6岁时神经行为发育的其他指标。通过25家国内研究中心的参与和最近在英国增加的研究中心实现了入组。该补助金将为整个NEAD研究网络提供所需的统计和数据管理支持。它将支持扩大临床“补助金”，旨在跟踪儿童到6岁，届时神经行为测量可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，并改善其子女的健康。DSCC将促进这一奋进的及时性和质量。