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National Children's Study

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The National Children's Study (NCS) was a longitudinal cohort study that planned to recruit participants from across the United States of America. It was intended to measure the many factors that contribute to health and disease from before birth through age 21. This included, but was not limited to, the search for drivers of diseases with prenatal or developmental origins. The Study was closed in December 2014.[1][2]

Organization

The NCS was led by the National Institutes of Health, with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) serving as the scientific lead. Within NICHD, the NCS Program Office administered the implementation of day-to-day Study operations. The Program Office was supervised by the Study Director, Steven Hirschfeld, MD, PhD Associate Director for Clinical Research, NICHD.

For advice and recommendations regarding Study framework, content, and methodologies, the NCS Program Office engaged external advisors and scientific groups. These groups included federal partners such as the NCS Federal Advisory Committee and a Federal Consortium with representatives from multiple federal agencies including: the U.S. Department of Health and Human Services, the National Institute of Environmental Health Sciences of the National Institutes of Health, the Centers for Disease Control and Prevention, and the U.S. Environmental Protection Agency. An independent Study Monitoring and Oversight Committee monitored study progress and participant safety.

In addition to these more formal channels, the NCS solicited feedback from subject matter experts from around the world and from individuals, community advocates, and professional societies concerned with child health. The NCS Program Office also provided public forums for input on a variety of initiatives.[3]

Congressional Mandate

The "President’s Task Force on Health Risks and Safety Risks to Children" recommended this federal initiative in 1999, after which Congress passed the Children's Health Act of 2000 (Title X, Section 1004). The Act charged NICHD to:

  1. plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of both chronic and intermittent exposures on child health and human development; and
  2. investigate basic mechanisms of developmental disorders and environmental factors, both risk and protective, that influence health and developmental processes.

The Act required this NCS to:

  1. 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;
  2. gather data on environmental influences and outcomes on diverse populations of children, which may include the consideration of prenatal exposures; and
  3. consider health disparities among children, which may include the consideration of prenatal exposures[4]

Objective

The NCS was designed to examine the effects of the environment—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. The NCS was designed to follow approximately 100,000 children, some from before birth, through age 21 years. The NCS planned to collect comprehensive information to:

  1. contribute to improving the health and well-being of all children
  2. deepen our understanding of the contribution of various factors to a range of health and disease outcomes
  3. understand factors that lead to health disparities.

With this broad perspective, the NCS was designed to contribute to the implementation of health equity, where each individual has an opportunity to realize their health potential.[5]

Discontinued

The NCS was in its Vanguard, or pilot phase, which was designed to assess the feasibility, acceptability, cost, and utility of Study scientific output, logistics, and operations prior to initiating the Main Study. The Vanguard Study enrolled about 5,000 children in 40 counties across the United States. General recruitment was completed in July 2013.

On December 12, 2014, the National Children's Study closed, after an expert review committee advised the NIH Director that moving forward with the larger Main Study would not be the best way to add to the understanding of how environmental and genetic factors influence child health and development.[6]

The NCS will not collect any new information from participants.[citation needed]

The NIH plans to make data already collected available to researchers in late 2015.[citation needed]

References

  1. ^ Jocelyn Kaiser (December 12, 2014). "NIH cancels massive U.S. children's study". Science. Retrieved December 16, 2014. has too many flaws to be carried out in a tight budget environment, advisers today told National Institutes of Health (NIH) Director Francis Collins. He announced he is dismantling the study immediately.
  2. ^ Francis S. Collins (December 12, 2014). "Statement on the National Children's Study". hih.gov. NIH. Retrieved December 14, 2014. I am appointing Dr. David Murray, NIH Associate Director for Prevention, effectively immediately, to manage the orderly transition of the NCS program office and closure of the study.
  3. ^ "Archived copy". Archived from the original on 2014-10-06. Retrieved 2014-09-29.{{cite web}}: CS1 maint: archived copy as title (link)
  4. ^ National Institutes of Health New Proposed Collection; Comment Request; Neuropsychosocial Measures Formative Research Methodology Studies for the National Children's Study Federal Register, vol 76, No. 84, May 2, 2011
  5. ^ "Archived copy". Archived from the original on 2014-10-06. Retrieved 2014-09-29.{{cite web}}: CS1 maint: archived copy as title (link)
  6. ^ National Children’s Study (NCS) Working Group FINAL REPORT – DECEMBER 12, 2014 National Institutes of Health, Advisory Committee to the Director, 19 pages
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