October 2007

What is the National Children’s Study?
The National Children’s Study is the largest long-term study of environmental and genetic effects on children’s health ever conducted in the United States. By following 100,000 children from before birth to age 21, study researchers hope to better understand how children’s genes and their environments interact to affect their health and development. In the study, “environment” includes factors such as: air, water, and house dust; what children eat; how they are cared for; the safety of their neighborhoods; and how often they see a doctor.

What will we learn from the study?
The study will examine important health issues, including: birth defects and pregnancy-related problems; injuries; asthma; obesity; diabetes; and behavior, learning, and mental health disorders to establish links between children’s environments and their health. By tracking children’s development through infancy, childhood, and early adulthood, the study hopes to determine the root causes of many childhood and adult diseases. Findings from the study will benefit all Americans by providing researchers, health care providers, and public health officials with information from which to develop prevention strategies, health and safety guidelines, and possibly new treatments and cures for disease.

How will the study be conducted?
The study will be conducted in 105 locations (counties or groups of counties) across the United States. All locations were selected using a probability-based method to ensure that children and families across the nation—from diverse ethnic, racial, economic, religious, geographic, and social groups—are fairly represented in the study. In these locations, study teams will work with health care professionals and community leaders to recruit women who are pregnant or are likely to become pregnant in the near future for participation in the study. Most families will be recruited door-to-door. Others will join through their local physicians’ offices, health clinics, and hospitals.

Initially, researchers will collect information on women’s pregnancies, including their diets, environments, chemical exposures, and emotional stress. When their children are born, and periodically thereafter, researchers will collect biologic samples and environmental samples like air, water, and dust from their environments. Researchers will meet with families in both their homes and in clinical settings, and data also will be collected remotely via telephone, computer, or mail-in questionnaires.

How many new study centers were awarded, and what study locations are they managing?
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) awarded 22 new study centers in September 2007. These centers will manage study operations in 26 of the 105 previously designated study locations.

The newly awarded study centers will manage the study in 20 states. There are study locations in both urban and rural areas. Fifteen locations are in the Eastern part of the country, and 11 are in the West. (See http://nationalchildrensstudy.gov/study_centers/upload/Study_Centers.pdf for a complete list of centers and the locations they will manage).

What is the difference between a study center and a study location?
It is important to distinguish between study centers and locations. Study centers are organizations or institutions, often working in collaboration, which are engaged through a federal contract to conduct the study. Study locations are the previously designated geographic areas, or counties, where the study will be conducted, and where eligible participants reside. A map and list of all study locations can be found at http://www.nationalchildrensstudy.gov/about/locations/.

How were the new study centers selected?
Study centers were selected from a pool of applicants assessed through a competitive process. They successfully demonstrated the ability to collect and manage biologic and environmental specimens; identify community networks for recruiting and retaining eligible mothers and infants; and protect the privacy of participant data.

How will study centers support the study?
The study centers, including the Vanguard centers, will work within their communities to recruit participants, collect and process data, and test the study’s different research components for incorporation into the full study. Study centers are responsible for reporting to the study’s Program Office, and some will manage operations in more than one study location.

The newly-awarded study centers will begin activities in 26 locations this year, including preparing for recruitment, hiring and training staff, determining community needs, and setting up community advisory boards.

What is the difference between a Vanguard center and a study center?
The Vanguard centers are the first seven study centers that were established in September 2005. They will be the first to recruit participants and will test the study’s different components for incorporation into the full study. All of the centers established after the Vanguard centers are referred to as study centers.

Who designed the study and how was it developed?
The U.S. Department of Health and Human Services (including the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Environmental Health Sciences, and the Centers for Disease Control and Prevention) and the U.S. Environmental Protection Agency are leading the study. Members of the National Children’s Study Federal Advisory Committee—including its working groups of more than 2,400 obstetric, pediatric, and environmental health researchers from federal agencies, the private sector, and non-governmental organizations—completed the groundwork that helped the lead federal agencies design and develop the study.

What is the source of funding for the National Children’s Study, and does funding the study mean that other NIH research funds will be reduced?
Fiscal Years 2000 to 2006, the early development and initial implementation years of the study, were funded with lead supporting agency funds: 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. In Fiscal Year 2007, the NIH received a Congressional appropriation of $69 million specifically for the National Children’s Study to support funding Study Centers in additional communities across the country and allow the Vanguard Centers to prepare to recruit women into the study. In December 2007, a Congressional appropriation of $110.9 million was received for Fiscal Year 2008. These funds will be used to prepare for recruitment in current Study Centers and to begin recruiting participants in the Vanguard Centers. Additionally, a third round of new Study Centers will be solicited.

Who will participate in the study and how will they be recruited and retained?
Families who participate in the National Children's Study will come from 105 previously designated locations, which include U.S. counties or groups of counties from across the country, and will be from many different racial, ethnic, and socioeconomic groups. Recruitment efforts for the study will include community based grassroots campaigns to promote the formation of community partnerships; to build relationships with area obstetricians and other health care providers; and to direct outreach to parenting groups, religious, and community institutions, as well as other organizations offering health information and support to families. The National Children’s Study will seek to retain participants by maintaining strong relationships between study staff and the children and families involved in the study, as well as by engaging local community groups and activists. Some tools and activities to promote connection and cohesion among participants may include newsletters, interactive Web sites for the children, periodic get-togethers, and public presentations. As with most studies of this kind, participants will receive compensation for their participation.

What study centers (Vanguard centers) are already operational?
The Vanguard centers were awarded contracts in 2005, and have been preparing for participant recruitment since then. (See http://nationalchildrensstudy.gov/about/locations/ for a list of Vanguard centers and the locations they manage.)