The National Children's Study Awards Six Contracts to First Study Centers and One Coordinating Center
The National Children’s Study today awarded contracts to six Study Centers and one Coordinating Center, signifying a major step in implementing the largest long-term study of children’s health and development ever conducted in the United States. The Study Centers awarded today will be the first to recruit participants and collect data in local communities as part of this decades-long research effort.
The selected Study Centers, called Vanguard Centers, are:
- University of California-Irvine with Children’s Hospital of Orange County for Orange County, CA
- Mt. Sinai School of Medicine with Columbia University Mailman School of Public Health, New York City Dept. of Health and Mental Hygiene, University of Medicine and Dentistry of New Jersey, and Columbia University Dept. of Obstetrics and Gynecology for New York City (Queens), NY
- University of North Carolina at Chapel Hill with Battelle Memorial Institute, and Duke University for Duplin County, NC
- Children’s Hospital of Philadelphia and Drexel University School of Public Health with University of Pennsylvania for Montgomery County, PA
- University of Utah for Salt Lake County, UT
- University of Wisconsin-Madison and Medical College of Wisconsin with National Opinion Research Center, Marquette University, UW Marine and Freshwater Biomedical Sciences Center/Institute for Environmental Health, and Children’s Service Society of Wisconsin for Waukesha County, WI
Negotiations are continuing with other counties for additional Centers.
The six Vanguard sites mark the first of the now 105 locations across the country where the National Children’s Study will be carried out. Most Study sites were chosen earlier based on criteria such as geographic and demographic diversity, number of births, and number of babies born with low birth weight.
By following 100,000 children from before birth to age 21, National Children’s Study researchers seek to better understand how children’s genes and environments interact to affect their health and development. Together, children enrolled in the Study will reflect the diversity of children nationwide.
“The National Children’s Study will provide information that can lead to improvements in health for millions of American children,” said Duane Alexander, MD, director, National Institute of Child Health and Human Development. “And it may be able to pinpoint the root causes of numerous conditions and diseases, such as asthma, obesity, and autism.”
The National Children’s Study selected the Vanguard Centers from a pool of applicants through a competitive process. Winning centers are the entities that will carry out the Study at the given sites. Centers successfully demonstrated that they possessed advanced clinical research and data collection capabilities; the ability to collect, process, package, and ship biological and environmental specimens; community networks for identifying, recruiting, and retaining eligible mothers and infants; and a commitment to the protection and privacy of data.
Excitement is high in the wake of the awards. “We are delighted by the high caliber of institutions that were selected, and eagerly anticipate getting the Study up and running in these initial sites,” said Peter Scheidt, MD, MPH, director, National Children’s Study.
Vanguard Centers will work closely with communities to encourage and maintain local support for the Study—at the same time ensuring that local maternal and child health concerns are taken into account.
Beginning in 2007, each Vanguard Center will aim to enroll at least 250 newborns, each year for five years. Most participants will be recruited at their homes. Others will join during prenatal care visits at physicians’ offices, clinics, and hospitals. Before recruitment can begin, Vanguard Centers will participate in finalizing the protocol and will begin hiring and training staff.
Also today, the National Children's Study announced that Westat with Harvard Medical School, University of Pennsylvania, and Daston Communications, with several other small-business subcontractors, will run the Study Coordinating Center, which will provide scientific, technical, and logistical support to all Study Centers.
The Coordinating Center will play a crucial role in the overall implementation and conduct of the Study, coordinating interaction between the Study Centers, communities, labs, and repositories. It will have primary responsibility for the Study's information management system, statistical sampling, coordination of data collection, quality control, and data analysis. Sarah Knox, PhD, the National Children's Study project officer for the Coordinating Center, said that she is excited about the level of expertise, competence, and experience that Westat will bring to the complex tasks involved.
The U.S. Department of Health and Human Services—through the National Institutes of Health and the Centers for Disease Control and Prevention—and the U.S. Environmental Protection Agency are leading the Study.
Pending availability of funding, the National Children’s Study plans to issue Requests for Proposals for an additional 30–50 Study Centers in 2006.
New Locations for the National Children’s Study Added for Geographic and Ethnic Diversity
Following on the previous augmentation of the sample to ensure that rural areas are proportionately represented in the Study, four additional counties are being added to the National Children’s Study sample. To provide a broader range of metropolitan areas and to improve the geographic distribution and the diversity of the sample, the National Center for Health Statistics applied its sampling algorithms to the original National Children’s Study strata and identified four additional sites. This will expand the total number of Study sites to 105. The additional sites are Polk County, IA; Bristol County, MA; Valencia County, NM; and Hinds County, MS. The map of Study locations has been updated, and the new Study locations have been notified. Any alterations in the recruitment goals or roles of Study Centers will be addressed when the Request for Proposals for the remaining Study Centers is announced. The goals and roles of the Vanguard Centers are not affected by this augmentation of the sample.
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The National Children's Study is led by a
consortium of federal agency partners:
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and Prevention
U.S. ENVIRONMENTAL PROTECTION AGENCY