April 2012
What is the National Children’s Study?
What will we learn from the Study?
How will the Study be conducted?
What is the Vanguard Study?
What is the difference between a Study location and a Study Center?
How were Study Centers selected?
What makes this study different from other studies?
How was the Study design developed?
What is the source of funding for the National Children’s Study?
What is the National Children’s Study?
The National Children’s Study will examine the effects of the environment, as broadly defined to include factors such as air, water, diet, sound, family dynamics, community and cultural influences, and genetics on the growth, development, and health of children across the United States, following them from before birth until age 21 years. The goal of the Study is to improve the health and well-being of children and contribute to understanding the role various factors have on health and disease. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible.
The National Children’s Study is:
- data-driven
- evidence-based
- community and participant informed.
What will we learn from the Study?
Data from the Study may inform research into many conditions such as, but not limited to, 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 children’s health. By taking a long-term view of children from birth to adulthood, the Study hopes to learn more about how children grow healthy and how this leads to healthy adults by determining the root causes of many childhood and adult diseases. The Study will examine how events and exposures early in life can lead to specific outcomes.
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 guide future research.
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How will the Study be conducted?
The National Children’s Study is an observational research study. Participants will be asked to answer questions, and not to change what they normally do. The Study staff may visit with families at home, at other places where the child spends a lot of time, and at the local Study Center. Study staff will also contact participants to collect data remotely by telephone, computer, or mail-in questionnaires.
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 the children’s environments.
The Study will be conducted in Study locations across the United States.
What is the Vanguard Study?
There are two related phases of the National Children’s Study: the Vanguard Study and the Main Study. The Main Study will focus on exposure outcome relationships with a data driven, evidence-based approach. The Vanguard Study will evaluate the feasibility, acceptability, and cost of three different recruitment strategies, as well as Study procedures and outcome assessments that are to be used in the Main Study. Feasibility refers to technical performance and reliability; acceptability looks at the impact on Study participants and Study infrastructure; and cost examines the level of effort, personnel, resources, and money.
The Vanguard Study will be conducted in 40 Study locations and is designed to help provide the detailed preparation needed to implement a study of this scope and complexity. The Vanguard Study began prior to the Main Study and both studies will run in parallel and will follow children from birth to age 21. The Main Study will begin once sufficient data is collected and analyzed from the Vanguard Study.
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What is the difference between a Study location and a Study Center?
Families who participate in the National Children’s Study will come from Study locations across the United States.
Study Centers are contractors that carry out the research and conduct the Study at selected Study locations. They will work within a designated Study location to recruit participants and collect and process data. Study Centers report to the Study’s Program Office.
Maps and a list of all Study Centers and their locations can be found at http://www.nationalchildrensstudy.gov/studylocations/.
How were Study Centers selected?
Study Centers were selected from a pool of applicants assessed through a competitive contract award process.
What makes this study different from other studies?
The National Children’s Study includes many factors that make it a unique study:
- Scientific Scope – The Study has the broadest shape of any longitudinal observational study ever undertaken. It will collect more samples, specimens, measurements, and health history than any other study to date. The Study will collect a broad array of environmental samples, genetic information, health history, and information about learning and behavior.
- Size – The Study intends to enroll enough families to ensure that information about most common events, and many rare events, can be recorded. The current estimate is that at least 100,000 families will be enrolled in the Study.
- Duration – The Study intends to identify women prior to or around the time of conception, follow them through the birth of their child, and follow their children through 21 years of age. No study has ever followed children from before their birth through age 21.
How was the Study design developed?
The National Children’s Study is led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (NIH) in collaboration with a consortium of federal government partners. Study partners include the National Institute of Environmental Health Sciences of the NIH, the Centers for Disease Control and Prevention, and the Environmental Protection Agency. Experts from the federal government, academia, community and other organizations, provided input to the National Children’s Study Program Office over a period of several years. A scientific plan was developed and reviewed by the National Academy of Sciences and subsequently a protocol was drafted and reviewed by the Office of Management and Budget and the National Children’s Study Federal Advisory Committee.
What is the source of funding for the National Children’s Study?
The Study is funded by a designated appropriation from the United States Congress. For additional information, you can view the Funding and Legislation page.
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