Planned National Children's Study

NICHD September Announces Contracts to First Research Centers for Planned National Children's Study

The National Children's Study-planned to be the largest study ever undertaken to assess the effects of the environment on child and adult health-took a major step forward today with the announcement that contracts have been awarded to 6 Vanguard Centers to pilot and complete the first phases of the Study.

The full nationwide study would follow a representative sample of children from early life through adulthood, seeking information to prevent and treat such health problems as autism, birth defects, diabetes, heart disease, and obesity.

"The National Children's Study would follow more than 100,000 children, from before birth-and, in some cases, even before pregnancy," said Duane Alexander, M.D., Director of the National Institute of Child Health and Human Development, one of the National Institutes of Health (NIH). “It would meticulously measure their environmental exposures while tracking their health and development, from infancy through childhood, until age 21, seeking the root causes of many childhood and adult diseases."

The announcement was made at a news briefing in Washington, D.C. In the search for environmental influences on human health, and their relationship to genetic constitution, National Children's Study researchers plan to examine such factors as the food children eat, the air they breathe, their schools and neighborhoods, their frequency of visits to a health care provider, and even the composition of the house dust in their homes.

Study scientists also plan to gather biological samples from both parents and children and analyze them for exposure to environmental factors. The planned National Children's Study is led by a consortium of federalagency partners: the U.S. Dept. of Health and Human Services (including the National Institute of Child Health and Human Development and the National Institute of Environmental Health Sciences at NIH, and the Centers for Disease Control and Prevention) and the U.S. Environmental Protection Agency.

Dr. Alexander named the following Institutions as the Vanguard Centers for the National Children's Study
* University of California, Irvine, for the Study location of Orange County, California; * University of North Carolina at Chapel Hill, for the Study location of Duplin County, North Carolina;
* Mount Sinai School of Medicine, New York, for the Study location of Queens County, New York;
* Children's Hospital of Philadelphia, for the Study location ofMontgomery County, Pennsylvania;
* University of Utah, Salt Lake City, for the Study location of Salt Lake County, Utah;
* University of Wisconsin-Madison, Madison, for the Study location of Waukesha County, Wisconsin.

The federal agencies sponsoring the Study are still negotiating toestablish two additional Vanguard Centers that will serve counties inother areas. The Vanguard Centers were selected from a pool of applicants through acompetitive process.

These centers have successfully demonstrated advanced clinical research and data collection capabilities, with the ability to collect and manage biological and environmental specimens; with community networks for identifying, recruiting, and retaining eligible mothers and infants; and a commitment to the protection and privacy of data.

The Vanguard Centers, which include a variety of universities, hospitals, health departments and other organizations, will work within their communities to recruit participants, collect and process data, and pilot new research methods for incorporation into the full study. The Study has adequate funding to launch the Vanguard Centers.

The federal agencies leading it hope to award additional Study Centers to work in a total of 105 sites, subject to the availability of future funding. Future centers would be selected in a competitive process like the one just completed for the Vanguard Centers.

The timing of a new competitive process also depends on future funding. Dr. Alexander added that a coordinating center, Westat in Rockville, MD, has been awarded the contract to manage information for the plannedNational Children's Study, starting with the Vanguard Centers.

Westat will collect data, compile and analyze statistics, and ensure that thestudy proceeds according to design. Dr. Alexander noted that, in many cases, study researchers would recruit women before they are even pregnant, as well as the women's partners. Because many pregnancies are unplanned, the researchers will also recruit women who are not considering pregnancy.

"The study might eventually lead to preventions or treatments for many common conditions," said Vice Admiral Richard H. Carmona, M.D., M.P.H.,FACS, the United States Surgeon General.

"We're looking to find the root causes of many common diseases and disorders," Dr. Carmona said. "When we do, we'll be in a position toprevent them from ever occurring."

Dr. Carmona added that the study could also shed light on such indoor environmental exposures as secondhand smoke, lead, radon, and asbestos. "We now know that one in five schools in America has indoor air quality problems, which affect millions of children who don't even realize it,"Dr. Carmona said. "And that's where The National Children's Study comes in. The study could help us map how our environments, habits, and activities affect our children's health."

Other speakers at the briefing included representatives of the federalagencies sponsoring the study, as well as representatives of associations concerned with children's health.

The NICHD is part of the National Institutes of Health (NIH), the biomedical research arm of the federal government. NIH is an agency ofthe U.S. Department of Health and Human Services. The NICHD sponsors research on development, before and after birth; maternal, child, andfamily health; reproductive biology and population issues; and medical rehabilitation.