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 National Children's Study Releases Study Plan and Locations (November 2004)

 Special Edition

National Children's Study Releases Study Plan and Locations

November 16, 2004

The National Children's Study enters the implementation phase today with the release of a Study Plan, outlining objectives, methodologies, and measures related to the first years of the 21-year Study; the announcement of the locations across the United States where the Study will be conducted; and the posting of requests for proposals for institutions to manage initial Study sites and for a coordinating center.

The Study, led by the U.S. Department of Health and Human Services—through the National Institutes of Health and the Centers for Disease Control and Prevention—and by the U.S. Environmental Protection Agency (EPA), has designated 96 locations across the United States where it will recruit and enroll eligible participants, and track them over 21 years. Together the children from these 96 locations will represent the face of all of America's children.

"We are now beginning the National Children's Study, the most ambitious attempt ever undertaken to understand the role that the environment plays in children's health," said Duane Alexander, MD, director of the National Institute of Child Health and Human Development. "We look to the National Children's Study to provide important information that will safeguard the health of our children and the adults they will become."

The ability to examine multiple exposures and link them in cause-effect relationships with multiple outcomes is the defining characteristic of the National Children's Study. The Study will examine many aspects of children's lives, from family genetics; to the constructed world of neighborhoods and schools; to chemical exposures linked to the atmosphere, food, or water supplies; to the social and behavioral environment in which the children grow and develop.

"From the water we drink and the air we breathe to the foods we eat, it is important to know how environmental factors impact the health of our children. Only a study of this size and scope holds the promise of shaping the care of children for the next century," said Paul Gilman, PhD, assistant administrator, Research and Development, EPA.

The Study Plan is an outline of the sampling methodology, participation requirements, and type and scope of data collection for the first few years of the Study. Although the Study is hypothesis-driven, no single hypothesis fulfills the goals of the study. There are a number of hypotheses described in the Study Plan that are designed to address several priority health outcome themes: outcomes of pregnancy, child growth and development, injury, asthma, and psychological and emotional health.

"The American Academy of Pediatrics (AAP) and its member pediatricians believe the National Children's Study will yield valuable information," said AAP President Carol Berkowitz, MD, FAAP. "It will ultimately enable us to learn much more about, and further improve, the care we give to our patients."

Successful implementation in each of the 96 Study locations will depend on the input and support of entire communities. The Study will seek the collaboration of researchers, governmental and health officials, social service agencies, schools, churches, and community organizations. Local efforts in each community will emphasize community partnerships and collaboration, from planning, to recruitment, to retaining participation throughout the length of the Study.

children at school 

Study Plan

Enrollment will include three distinct groups: pregnant women and their partners, couples planning pregnancy, and women of child-bearing age but not planning a pregnancy. The National Children's Study will be the first large longitudinal study of children to capture exposures from pre-pregnancy and early pregnancy and to examine outcomes of exposures in the context of a child's genetic makeup.

Families who are enrolled in the Study will participate in a minimum of 15 in-person visits with local Study research teams starting in the first trimester of pregnancy or earlier through 21 years of age. Seven of these visits will be in the participants' homes and eight will be in clinical settings, including the infants' place of delivery. Data will also be remotely collected via telephone, computer, or mail-in questionnaires every three months through the age of five and annually thereafter. Biological samples from the mother and child, as well as air, water, dirt, and dust from the child's environment, will be collected over the course of the Study.

Study Locations

Study locations roughly correspond to U.S. counties or clusters of counties. The locations were selected through a rigorous national probability selection method that ensures that children across the nation are fairly represented in the Study. Eight of these have been designated as potential locations for the first stage of implementation, referred to as Vanguard locations. Based on the availability of funding, three to eight vanguard locations will be launched in 2005, chosen through a competitive process. To learn more about how the locations were selected, see "The National Children's Study: Representing America's Children" on the Study's Web site.

By design, the selected locations are geographically dispersed and demographically varied. By including families from varied backgrounds and family structures, the Study can better investigate issues of vital interest to all communities. Variables for location selection included number of births, demographics, and number of babies born at a low birth weight.

"We believe that the National Children's Study will help us improve the quality of care we give to all of the nation's children. While the National Hispanic Medical Association (NHMA) is particularly concerned about the diseases impacting Latino children, such as diabetes, the Study will help us all better understand how to prevent, diagnose, and treat diseases in all children," said Elena Rios, MD, MSPH, president and chief executive officer, NHMA.

Vanguard Sites and Coordinating Center

The complete Study plan and the request for proposals for institutions to manage potential Vanguard locations can be viewed at
The request for proposals for the coordinating center can be viewed at

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The National Children's Study is led by a
consortium of federal agency partners:

National Institutes of Health
Centers for Disease Control and Prevention