This information about the original Study Plan is being provided for historical purposes only.
November 16, 2004
The National Children’s 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. 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, and the focus of the Study Plan.
The National Children’s Study will observe 100,000 children from before birth to their twenty-first birthdays. Initially, participants will include three distinct groups: pregnant women and their partners, couples planning pregnancy, and women who are of childbearing age but are not planning a pregnancy.
The National Children’s Study will be the first effort to capture exposures prior to and early in pregnancy, and to then track participants for more than 20 years. Other studies have looked at prenatal exposures, but they either started in the first trimester of pregnancy, or stopped tracking at birth.
The Study Plan focuses on several priority health themes: outcomes of pregnancy, child growth and development, injury, asthma, and psychological and emotional health. The Plan outlines the measures of exposures and the schedule of data collection for the first few years of the Study.
In developing the Study Plan, the National Children’s Study relied on the expertise and input from the National Children’s Study Federal Advisory Committee; its working groups of experienced obstetric, pediatric and environmental health researchers representing federal agencies, the private sector, child health and environmental advocacy groups; and others.
Hypotheses
Although the Study is hypothesis-driven, no single hypothesis fulfills all the goals for the Study. To determine environmental impact on the health of children, the Study includes a number of hypotheses and priority health outcomes. Together, they represent an approach to addressing the nation’s most urgent public health concerns. By design, the Study hopes to be able to answer future questions about children’s health that science has yet to ask.
Data Collection
- Families who are enrolled in the Study will participate in a minimum of 15 in-person visits with a local research team beginning the first trimester of pregnancy or earlier, through 21 years of age. Some of these visits will be in the participants’ homes and some will be in clinical settings, including the infant’s place of delivery. For a sample of participants, data will also be collected from child care and school settings to include places where the child spends at least 30 hours per week.
- In addition to in-person visits, data will be remotely collected via telephone, computer, or mail-in questionnaires every three months through the first year of life, and then at slightly longer intervals until the child reaches 21 years of age.
- Samples collected over the course of the study will include biological samples from the mother, father, and child, as well as air, water, soil, and dust from the child’s environment.
Measures and Outcomes
- The data collection will involve measures of environmental exposures that will be tracked and analyzed in relationship to health outcomes. Biological, chemical, physical, and psychosocial exposures will be collected, measured, and tracked against pregnancy and birth outcomes, stages of child development, and medical events.
- The ability to assess the influence of multiple environmental exposures on one or more outcomes is an important and unique facet of the Study.
Results
- Beginning with birth outcomes, findings will become available within two to three years after the Study is launched. Throughout the Study’s duration, intermittent results will allow for continued insights that may be applied to better the health of America’s children.
- The Study Plan is written as an outline so that it may evolve as the cohort ages and as new scientific developments occur. A more detailed Research Plan and Study protocol will be developed with the input of investigators from the Vanguard Centers and coordinating center.
The full Study Plan (PDF 2.04 mb) is being provided for historical purposes only. As the Study has progressed, new information has replaced some of the material in the Study Plan.
More recent information on the Study design is available in the Research Plan.