The Biometry and Field Studies Branch is the Statistical Coordinating Center for the ongoing clinical trial of the behavioral and cognitive side effects of phenobarbital used for prevention of febrile seizure recurrence. The accrual of patients has been completed, with 367 patients on study. Follow-up with psychometric testing will continue for another two years. The original data management system which dealt with data entry, data editing and data retrieval was developed for an HP mini-computer at the Biometry and Field Studies Branch. During the year, the system met with both hardware and HP software problems that necessitated a transfer of the data management capabilities to a new system. The entire data management system was recreated, and is now housed and operated on the main frame computer at NIH. During this fiscal year, three interim analyses of the data were performed for evaluation by the Performance and Safety Monitoring Committee. In addition, extensive data editing is continuing, creation of structured files for analysis is near completion, the distribution of the outcome variables have been examined and strategies are being developed for final analysis.
