Maternal Lifestyle Study: Phase 5

The goal of the request for a funding report and the request for carry-over funds is to be able to close out Maternal Lifestyle Study after 20 years since its inception. This has been a complex study and the Memphis site (University of Tennessee) has enrolled 355 mother infant dyads from approximately four thousand screened in Phase I soon after delivery/birth at the Regional Medical Center in Memphis. At 16 years we have a retention rate close to 80%, the highest among the 4 centers that enrolled subjects for longitudinal follow-up. We have stored video tapes of each child's assessments at various phases of the study and also volumes of paper records for multiple visits which we kept for data edit checks as well as for institutionallRB inspections and audits. Our attention to details and carrying out all research procedures according to study procedures and in compliance with IRB and HIPAA regulations have resulted in either no citations or very few recommendations or "minor comments" from the IRB. In our informed consent we have informed families that we will contact them regarding termination or continuation of the study depending upon successful funding application. Now that our application review has resulted in score that has not reached the funding level, we will close out the project during the period April 1, 2011 to March 31 51 2012, and will need to inform families accordingly.