National Children s Health Study
|First Submitted Date||February 26, 2009|
|First Posted Date||February 27, 2009|
|Last Update Posted Date||October 19, 2017|
|Start Date||February 25, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Life course assessment of the interaction between environmental exposures and genetics on child health and development|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00852904 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||National Children s Health Study|
|Official Title||Vanguard Phase of the National Children s Study|
Patterns of illness among children in the United States and other industrially developed nations have changed substantially during the past 100 years. Before and during the first half of the previous century, infectious diseases were the primary threat to children s health. In contrast, the major illnesses and disorders that impair health, growth, and development today are chronic conditions stemming from the complex interaction of environmental exposures and inherent genetic factors. The Children s Health Act of 2000 directed the National Institute of Child Health and Development to conduct a national longitudinal study of environmental influences on children s health in the United States. The act specified that the study extend from the prenatal period to adulthood and investigate the short-term and long-term influences of physical, chemical, biological, and psychosocial environmental exposures on children s health and development, including behavioral, emotional, and educational outcomes in addition to physical health. The National Children s Study (NCS) is an observational longitudinal study that will enroll and follow a nationally representative sample of approximately 100,000 U.S.-born children from before birth through their 21st birthday. The study will screen all households within selected areas of 105 locations (primarily counties).
The major types of analysis of NCS data will include longitudinal exposure-outcome analysis, identification of causal pathways, analysis of neighborhood effects, evaluation of temporal effects within longitudinal data analysis of data from case-control data, and analysis of genomic data.
Women in their first trimester of pregnancy will be invited to participate in the pre-pregnancy portion of the NCS. Women who are not pregnant but have a high probability of becoming pregnant will be asked to participate in the early pregnancy portion of the NCS. All other eligible women will be asked if the study can contact them periodically to assess their pregnancy status. They also will be asked to contact the NCS should they become pregnant. Women identified as pregnant within 4 years after initial screening will be invited to enroll in the NCS.
The following information will be gathered:
Mother s data and information
Infant s data and information at birth
The National Children s Study (NCS) is a planned, observational, and longitudinal study that will enroll and follow a national sample of approximately 100,000 children born in the United States (US) to participating women from before birth through the child s 21st birthday. The goal of the NCS is to provide information that will ultimately lead to improvements in the health, development, and well-being of children. The primary aim of the NCS is to investigate the separate and combined effects of environmental exposures (chemical, biological, physical, and psychosocial) as well as gene-environment interactions on pregnancy outcomes, child health and development, and precursors of adult disease. In-person contacts with the NCS participants include visits during pregnancy, after delivery, and throughout infancy and childhood at the participant s home and sometimes in a clinical setting. The collection of biospecimens, environmental samples, and physical measures is involved in addition to the examination of the infant and periodic contacts with the family. In addition, interim phone interviews regularly occur with in-person contacts. The NCS consists of the NCS Vanguard Study with any sub-studies and the NCS Main Study with any sub-studies. The Vanguard Study is the precursor to the Main Study.
The NCS Vanguard Study is designed and implemented to determine the feasibility, acceptability and cost of the elements that will form the Main Study. The Vanguard Study enrolls participants at forty Study locations and will have a planned duration of 21 years following completion of enrollment. The Vanguard Study will precede the Main Study on an ongoing basis to pilot all aspects of the Main Study. The specific objectives of the Vanguard Study are:
Families who participate in the NCS will come from forty Study locations across the US. Study visit assessments are the tests, environmental samples, biospecimens, questionnaires and other forms of data acquisition that are scheduled at the study visits. The evaluation of the Vanguard Study will be based on a series of targeted and specific statistical techniques and tests selected for each evaluation. Multiple performance measures will be used to inform the scope, design, visit structure and schedule, mechanisms and procedures, and analysis plan for the Main Study.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999909083
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )|
|Study Sponsor||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 29, 2017|