The National Children’s Study U.S. Departm ent of Health and Hum an Services National Institutes of Health Centers for Disease Control and Prevention U.S. Environm ental Protection Agency December 2008
The National Children’s Study • Largest long-term study of children’s health and development ever to be conducted in the U.S. • Longitudinal study of children, their families, and their environment (before birth through age 21) • Approximately 100,000 children enables study of important but less common outcomes
Rationale for the National Children’s Study From The President’s Task Force on Environmental Health and Safety Risks to Children, 2000* • Compared to adults, children are especially vulnerable to environmental exposures – metabolism, behavior • Exposures to some agents demonstrate potential for serious developmental effects – lead, prenatal alcohol • Current known exposures of high frequency – pesticides, violence, media • Numerous high burden conditions with suspected environmental contribution – learning disabilities, autism, diabetes, asthma, birth defects, premature birth • Existing research too limited in size and scope to answer the questions • Life-course (longitudinal) design needed to correctly link with multiple exposures and multiple outcomes * Reappointed 2001 and 2003
The President’s Task Force on Environm ental Health and Safety Risks to Children – 1 9 9 8 * • To develop strategies to reduce risk of environmental exposures to children • Co-chairs: Secretary HHS, Administrator EPA • Members: 7 cabinet officers • Need for longitudinal study of effects of environmental exposures • Consultation (2000) endorsed study • Large, bold, multiple agencies, public private partnerships • New money required * Reappointed 2001 and 2003
PL 1 0 6 -3 1 0 : Children’s Health Act of 2 0 0 0 • (a) PURPOSE — … to authorize NICHD to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on children’s health and development. • (b) IN GENERAL — The Director of NICHD shall establish a consortium of representatives from appropriate Federal agencies (including the CDC and EPA) to: • (1) plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of both chronic and intermittent exposures on child health and human development; and • (2) investigate basic mechanisms of developmental disorders and environmental factors, both risk and protective, that influence health and developmental processes… • (e) AUTHORIZATION OF APPROPRIATIONS — There are authorized to be appropriated to carry out this section $18,000,000 for fiscal year 2001, and such sums as may be necessary for each the fiscal years 2002 through 2005.
Study Concepts • Study high priority and burdensome conditions (n~ 100,000) • Hypothesis driven • Exposure period begins with pregnancy • Environment and genetic expression • State-of-the-art technology • Consortium of multiple agencies • Extensive public-private partnerships • National resource for future studies
Priority Health Exposures, Outcom es Priority Exam ples Priority Health Exam ples Exposures Outcom es Housing quality, Physical Environment Pregnancy Outcomes Preterm, birth defects neighborhood Pesticides, phthalates, Chemical Exposures Autism, learning heavy metals disabilities, Neurodevelopment schizophrenia, and Behavior Infectious agents, conduct and behavior Biologic Environment endotoxins, diet problems Interaction between Genetics genes and Head trauma, environment Injury injuries requiring hospitalizations Family structure, Asthma incidence Asthma socio-economic status, and exacerbation Psychosocial milieu parenting style, social networks, exposure to Obesity and Physical Obesity, diabetes, media and violence Development altered puberty
Priority Environm ental Exposures • Physical environment: housing, neighborhoods and communities, climate, radiation… • Chem ical exposures: air, water, soil, food, dust, industrial products, pharmaceuticals… • Complex ubiquitous low-level exposures • Unique exposures (special sub-studies) • Biological environment: intrauterine, infection, nutrition; inflammatory and metabolic response… • Genetics : genetic components of disease; effects of environmental exposures on gene expression… • Psychosocial milieu: influence of family, socio- economics, community, stress…
Exam ples of Hypothesis-defining Questions • How is asthma incidence and severity influenced by the interaction of early life infection and air quality? • Are assisted reproductive technologies (ART) at increased risk of fetal growth restriction, birth defects, and developmental disabilities? • Does impaired maternal glucose metabolism during pregnancy cause obesity in children? • How does high level exposure to media content in infancy affect development and behavior in children? • Does pre- and post-natal exposure to endocrine-active environmental agents alter age at onset, duration, and completion of puberty?
Locations vs. Centers • Locations—geographic locations (counties) from which participants will be recruited • Selected by stratified probability sample of primary sampling units • 105 locations • Centers—entities or institutions that will carry out Study at the locations • Selected by a competitive process • Each will cover more than one location • Up to 40 centers
Sam pling and Centers • National probability sample important • Exposure-outcome relationship representative of the U.S. • Key exposures with varied distributions not missed • Clustered for community attributes, logistics • Centers of excellence important • Broad scientific input, top expertise and facilities • Probability sample by centers • Unique combination • Requires flexibility and adaptation of center to the scientific design
National Children’s Study Sam ple All Births ~ 4 m illion births in 3 ,1 4 1 counties in the Nation Sample of Study 1 0 5 locations Locations Selection of Sample of Study neighborhoods Segments All or a sam ple of Study households w ithin Households neighborhoods All eligible w om en in Study Women the household
National Children’s Study Sam ple • National probability sample – known chance of inclusion • Drawn by NCHS • 105 locations – corresponding to counties/ clusters; 79 metro, 26 rural • 13 very large counties; other counties placed into strata based on: • Metropolitan status • Geography • Average number of births per year • Race, ethnicity, percent low birth weight
* Wave 1 locations * @ Wave 3 locations Wave 1 Locations • Wave 2 Locations • Los Angeles County, CA Benton County, AR Maricopa County, AZ Apache County, AZ Sacramento County, CA San Mateo County, CA VanguarcllWave 1 San Diego County, CA Pinal County, AZ Denver, CO Locations • New Haven County, CT Kern County, CA Miami-Dade County, FL New Castle County, DE San Bernardino County, CA Will County, IL Wave 2 Locations DeKalb County, GA Ventu ra County, CA Genesee County, MI Fayette County, GA Douglas County, CO Macomb County, MI @ Wave 3 Locations Honolulu County, HI Litchfield County, CT Buncombe County, NC Bear Lake County, ID and Lincoln Baker County, FL Middlesex County, NJ 1:1 Locations Not Awarded and Uinta Counties, WY Hillsborough County, FL Warren County, NJ Cook County, IL Orange County, FL New York City (Brooklyn), NY Macoupin County, IL Baldwin County, GA Marion County, OR Worcester County, MA Polk County, IA Philadelphia County, PA Baltimore County, MD DuPage County, IL Travis County, TX Wayne County, MI Johnson, Union, and Williamson Thurston County, WA Ramsey County, MN Counties, IL 1:1 locations Not Awarded St. Louis, MO Jefferson County, KY Hinds County, MS New Orleans, LA Colbert County, AL Burke County, NC Bristol County, MA Humboldt County, CA Durham County, NC Montgomery County, MD Marion County, IN Rockingham County, NC Cumberland County, ME Saline County, KS Valencia County, NM Grand Traverse County, MI Jessamine County, KY Beauregard and Vernon Parishes, LA Nassau County, NY Lenawee County, MI Schuylkill County, PA Jefferson County, MO Becker, Clearwater, and Mahnomen Westmoreland County, PA Cumberland County, NC Counties, MN Providence County, RI Burlington County, NJ Stearns County, MN Bexar County, TX Passaic County, NJ Coahoma County, MS Cache County, UT New York City (Manhattan), NY Gaston County, NC King County, WA Monroe County, NY Stark County, ND Marion County, WV Cuyahoga County, OH Cleveland County, OK Lorain County, OH Comanche County, OK Spartanburg County, SC • VanguardlWave 1 Locations Bradley County, TN Orange County, CA Davidson County, TN Cumberland and Morgan Counties, TN Duplin County, NC Harris County, TX Childress, Collingsworth, Donley, New York City (Queens), NY Hidalgo County, TX and Hall Counties, TX Montgomery County, PA Lamar County, TX Dallas County, TX Salt Lake Cou nty, UT Grant County, WA Stephens and Young Counties, TX Waukesha County, WI THE NATIONAL • Lincoln, Pipestone, and Yellow Medicine CHILDREN'S Counties, MN, and Brookings County, SD STUDY HEALTH GP..OWTH ENVIIl..Of','MENT December 2008
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