National Children s Health Study

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: 1. Evaluation of recruitment, enrollment and retention strategies 2. Evaluation of study logistics and operations including sites and mechanisms of data acquisition, collection, transport and storage of environmental and biological samples, and design and performance of information systems 3. Evaluation of study visit assessments for feasibility, acceptability, reliability, reproducibility, cost, value, stability, and redundancy with other assessments 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.