As the seven Vanguard Centers and the Coordinating Center engage in start-up activities across the country, the President's budget for Fiscal Year 2007, released on February 6th, stated:
"No funds are included in the President's Budget Request for FY 2007 for the National Children's Study. The NCS planning activities that are on going under contract in FY 2006 will be brought to a close by the end of the fiscal year. There are no plans for the NIH to continue to pursue the full scale study in FY 2007."(NICHD Congressional Justification, 2/6/2006)
Thus, as it stands now, the National Children's Study is currently funded through the end of fiscal year 2006. Congress authorized the National Children's Study through the Children's Health Act of 2000, and has demonstrated continued interest in its welfare through discussions in Appropriations and other committee hearings, Appropriations Committee report language, and requests for briefings about the Study's progress. Most recently, the Senate in its report language for the FY 2006 appropriation directed the NICHD and Study Planners to have the NCS ready for implementation in FY 2007.
While action on the FY 2007 appropriation is in process, Study planners will continue to work towards completion of the Study protocol, and work with the Centers to establish other infrastructure to support the Study, such as developing the information management system, ethics guidelines, and a plan for recruitment and retention. At the same time they also will prepare for cessation of National Children's Study activities in 2007 as directed in the President's budget.
Dr. Peter Scheidt, Director of the National Children's Study said: "By fiscal year 2007, approximately 50 million dollars will have been spent in planning the Study. Over 2,500 scientists and community members from across the country have developed a Study Plan that defines research questions, hypotheses, and critical exposure and outcome measures beginning before pregnancy and continuing throughout the life cycle of children. In 2005, the Study designated Vanguard, or pilot, Centers in seven sites throughout the United States and created a coordinating center to implement the Study. In 2006 the Study plans to finalize the Study protocol."
In response to the Congressional request as we move to 2007 the staff will work to maximize the benefit of the considerable work and planning of the National Children's Study.
National Children's Study Convenes New Steering Committee
With the advent of seven Study Centers managing the current Vanguard sites, the National Children's Study established a new Steering Committee in November 2005 to address challenges and to identify best practices that arise during the course of the Study. Chaired by Study Director Peter Scheidt, MD, MPH, the new committee brings together Vanguard and Coordinating Center Principal Investigators and long-standing Study leaders, including representatives from the Interagency Coordinating Committee—a governing body of the Study—and other Program Office staff.
In FY 2006, committee members will provide input on the Study protocol, including issues like community engagement, recruitment, and data collection. Members will assess progress in data collection and management, monitor safety, and report on ethical issues as soon as they arise. The committee will also review proposals for adjunct studies, and identify additional training needs.
The Steering Committee met in the Fall and Winter of 2005 and again on January 10-11, 2006, to discuss adjunct studies, institutional review board procedures, the collection of biologic samples, and the Study protocol.
The National Children's Study 3-D Ultrasound Pilot Study
The National Children's Study (Study) recently conducted a pilot study looking at the feasibility of collecting 3-dimensional (3-D) fetal ultrasound data for the Study. The pilot study was led by Pauline Mendola, U.S. EPA, and member of the Study's Interagency Coordinating Committee (ICC), with assistance from Mark Klebanoff, NICHD, and Ken Schoendorf, CDC, also members of the ICC.
Though 3-D fetal ultrasound volumes may seem more attractive indicators of fetal growth than 2-D linear measures, they take more time, expertise, and may be less reliable. The practicality and validity of collecting 3-D ultrasound data in large-scale, multi-site epidemiologic studies is uncertain. In this study, 3-D and traditional 2-D ultrasounds were completed on 120 pregnant women from 2 study sites, evenly distributed across the 2nd and 3rd trimesters. Scans were read on-site and also stored on CD-ROM and shipped to a central site for another reading. Preliminary analyses of the data suggest that the 3-D measures may provide additional insight into late fetal growth.
However, there are concerns regarding the reliability of the 3-D measures, especially later in pregnancy. Furthermore, there was variation in the readings performed at the central site compared with the study sites. More formal analyses are being prepared for scientific presentation and publication.