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. ? ?
