This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an investigator-initiated industry-sponsored clinical research study to investigate the presence of cognitive dysfunction and craniofacial abnormalities among children exposed to antiepileptic drugs in utero. The current project is a continuation of studies underway by the principal investigator since 1991 investigating the effects of anticonvulsants on cognitive function and other clinical endpoints. In studies conducted between 1996 and 1999, children exposed to one of three anticonvulsants, either Dilantin, Tegretol or Phenobarbital were evaluated along with age, race and gender-matched controls. Craniofacial abnormalities and digit hypoplasia were examined in relation to cognitive testing results. Based on the results of previous studies showing that children exposed to Phenobarbital during pregnancy had a lower IQ (although within the normal range) than normal, the current study proposes to increase the sample size to 40 drug exposed and 40 matched controls in each of the 3 groups. Endpoints will be abnormalities in cognitive function and craniofacial anomalies. The outpatient use of the GCRC is requested over a 3-year period of time to examine these patients and collect data.
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