National Children s Health Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00852904
First received: February 26, 2009
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

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

Condition
Asthma
Diabetes
Obesity
Premature Birth
Autistic Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Vanguard Phase of the National Children s Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Life course assessment of the interaction between environmental exposures and genetics on child health and development

Estimated Enrollment: 13700
Study Start Date: February 2009
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852904

Contacts
Contact: Julia Slutsman (301) 496-8640 slutsmaj@mail.nih.gov
Contact: Steven Hirschfeld, M.D. (301) 496-0044 hirschfs@mail.nih.gov

Locations
United States, Maryland
National Institute of Child Health and Human Development (NICHD), 9000 Rockville Recruiting
Bethesda, Maryland, United States, 20892
Contact: Julia Slutsman    301-496-8640    slutsmaj@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Steven Hirschfeld, M.D. National Cancer Institute (NCI)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00852904     History of Changes
Other Study ID Numbers: 999909083, 09-CH-N083
Study First Received: February 26, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Children
Environment
Longitudinal
Cohort
Longitudinal Study
National Children's Study

Additional relevant MeSH terms:
Obstetric Labor Complications
Asthma
Autistic Disorder
Obesity
Premature Birth
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on July 23, 2014