| Conditions: |
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Asthma - Diabetes - Obesity - Premature Birth - Autistic Disorder |
| Purpose: |
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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
- Questionnaire data-interviewed and self-administered (e.g., demographics; current
pregnancy history; reproductive history; medical conditions; health behaviors; doctor
visits; medicines and supplements; housing characteristics; pesticides, product use;
occupation, hobbies; depression, stress; social support; diet; time and activity)
- Physical measures and clinical data (e.g., blood pressure, sonograms, height, weight,
body measurements)
- Biologic specimens (e.g., blood, urine, hair, saliva)
- Environmental samples during home visits (e.g., dust, air, water)
- Medical record abstraction
Infant's data and information at birth
- Cord blood and tissue samples of the placenta and umbilical cord
- Standardized neurobehavioral exam
- Physical measures and clinical data (e.g., length; weight; circumferences of head, arm,
abdomen, thigh)
- Meconium samples
- Medical diagnoses and treatment by report
- Selected Medical record abstraction
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| Study Summary: |
|
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:
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, reliability, reproducibility,
cost, value, redundancy with other assessments, stability and acceptability
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.
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| Criteria: |
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- IINCLUSION CRITERIA:
- Women aged 18-49 or pregnant residing in a selected NCS geographic segment at the
time of enrollment
- Pregnancy women aged younger than 18, and residing in a selected NCS geographic
segment at the time of enrollment, who are considered to be emancipated minors per
the laws of their jurisdiction or minor pregnant women who obtain parental consent
for participation
- Children born to enrolled women
- Biological fathers as identified by enrolled women
- Adult caregivers for enrolled children who have legal responsibility to authorize
needed care for an enrolled child
EXCLUSION CRITERIA:
- For potentially eligible women: Womens' self-report of infertility
- Adults who are unable to understand what is involved in NCS participation and grant
informed consent
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| NCT ID: |
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NCT00852904 |
| Primary Contact: |
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Principal Investigator
Steven Hirschfeld, M.D.
National Cancer Institute (NCI)
Julia Slutsman
Phone: (301) 496-8640
Email: slutsmaj@mail.nih.gov
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| Backup Contact: |
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Email: hirschfs@mail.nih.gov
Steven Hirschfeld, M.D.
Phone: (301) 496-0044
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| Location Contact: |
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Bethesda, Maryland 20892
United States
Julia Slutsman
Phone: 301-496-8640
Email: slutsmaj@mail.nih.gov
Site Status: Recruiting |