National Children s Health Study
|First Received Date ICMJE||February 26, 2009|
|Last Updated Date||March 14, 2014|
|Start Date ICMJE||February 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Life course assessment of the interaction between environmental exposures and genetics on child health and development|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00852904 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||National Children s Health Study|
|Official Title ICMJE||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 longitudinal Study that will enroll and follow a nationally representative sample of approximately 100,000 children born in the U.S to participating women from before birth through their 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 will include visits during pregnancy at the participant s home and in a clinical setting, collection of biologic samples and examination of the infant at birth, and periodic contacts with the family and child throughout infancy and childhood. Interim phone interviews between the in-person contacts also will occur. 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 National Children s Study 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 is currently enrolling participants at seven Vanguard Centers and will have a planned duration of 21 years following completion of enrollment and 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:
Study visit assessments are the tests, environmental sample collections, 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. There will not be a single hypothesis to test. Instead 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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||13700|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00852904|
|Other Study ID Numbers ICMJE||999909083, 09-CH-N083|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP