Click here to see the current list of Study hypotheses.
The National Children’s Study will study the complex relationship between health and the environment for approximately 100,000 U.S. children and their families. Enrollment representative of the U.S. population will begin before birth, some even before conception, and follow up will continue for at least 21 years. A thorough history of exposures, biological samples, and health outcomes will be obtained from pregnancy onwards, allowing for comprehensive statistically powerful analyses of the link between a wide range of exposures and genetic factors with child health and development.
Planning for the Study began in 1999 as an activity of the President’s Task Force on Environmental Health Risks and Safety Risks to Children. Title X of the Children’s Health Act of 2000 subsequently authorized the National Institute of Child Health and Human Development, in collaboration with the Centers for Disease Control and Prevention, the U.S. Environmental Protection Agency, and other appropriate federal agencies, to “…plan, develop, and implement a prospective cohort study, from birth to adulthood, to… incorporate behavioral, emotional, educational, and contextual consequences to enable a complete assessment of the physical, chemical, biological and psychosocial environmental influences on children’s well-being…”
The authorizing legislation calls for a broad and deep investigation of the multitude of factors potentially associated with all aspects of child health and development. The Study will be uniquely valuable in answering key children’s environmental health questions that cannot be answered using existing data or new data from cross-sectional or smaller longitudinal studies.
Only a longitudinal cohort study of the planned size and scope of the Study can substantiate the sought after causal relationships in order to resolve long-standing scientific questions. The gathering and inclusion of a broad range of multiple exposures and multiple outcomes represents both a powerful scientific tool as well as a budgetary efficiency. The depth of analysis across both common and less common exposures and genotypes simultaneously means that the complete picture of what causes and prevents disease will come into focus.
Hypotheses and Priorty Outcomes and Exposures
Hundreds of scientists and representatives from community groups and professional organizations have contributed to the identification of key children’s environmental health questions for the Study. The Study Design Working Group of the National Children’s Study Federal Advisory Committee (NCSAC) proposed the development of core hypotheses encompassing exposures and child health outcomes of great public health significance requiring long-term follow-up and which cannot be reasonably studied with fewer children or a different study design. These hypotheses are important to guide and support the determination of sample size and design for the Study and are essential to assure that specific research questions can be addressed by the Study. The set of research questions and their corresponding hypotheses garnered from this exercise forms the foundation of the Study and together provides: a rationale for a long-term, prospective study of approximately 100,000 children; the scientific framework to define the Study, including sample design, data collection, etc; as well as a “public identity” for the Study.
Working hypotheses developed by the multiple teams of scientists are posted in a summarized format as an efficient and dynamic reference of the current questions to be addressed by the Study. The current list of hypotheses continues to evolve. It is expected that some hypotheses still being refined will be added and, over the long course of the Study, new questions will emerge and be added to the Study and some of the hypotheses included may become outdated and discarded. However, there is consensus among scientists planning the Study that as a group, the hypotheses alone can neither convey the true breadth of the Study nor completely guide the planning and design of the Study. To further define the full scope and topics of the Study, priority outcomes along with priority exposures are identified as health areas for the Study. The priority exposures and outcomes serve as an organizing framework for the Study hypotheses.