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The National Children’s Study Bexar, Hidalgo and Travis County. Daniel E. Hale, MD and Donald J. Dudley, MD UT Health Science Center at San Antonio January 30, 2009. South Texas NCS Study Center. The National Children’s Study.

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the national children s study bexar hidalgo and travis county

The National Children’s Study Bexar, Hidalgo and Travis County

Daniel E. Hale, MD and Donald J. Dudley, MD

UT Health Science Center at San Antonio

January 30, 2009

South Texas NCS Study Center

the national children s study
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
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

examples of hypothes is defining questions
Examples 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?
timeline
Timeline
  • 1998 Presidents Task force on Environmental Health and Safety Risk in Children
  • 2000 Children’s Health Act of 2000 (PL106-310)
  • 2004 Vanguard Centers Selected
  • 2007 Wave 1 Sites/Centers Chosen
  • 2008 Wave 2 Sites/Centers Chosen
  • 2009 Participant Recruitment Begins – Vanguard Sites
  • 2010 Participant Recruitment Begins – Wave 1 Sites
  • 2011 Participant Recruitment Begins – Wave 2 Sites
  • 2012 Participant Recruitment Begins – Wave 3 Sites
sampling and centers
Sampling 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
    • Longevity, consistency and commitment
  • Probability sample by centers
    • Unique combination
    • Requires flexibility and adaptation of center to the scientific design
national children s study sample
National Children’s Study Sample

All Births

in the Nation

~4 million births in 3,141 counties

(25,000 =0.625%)

Sample of Study Locations

105 Locations, 8 sites, 13 Counties in TX

Selection neighborhoods

To provide ~25 infants/yr

Sample of Study Segments

All or a sample of households within neighborhoods

Study

Households

All eligible women in the household

Study Women

national children s study sample9
National Children’s Study Sample
  • National probability sample
  • Drawn by National Center for Health Statistics
  • 105 locations – corresponding to counties/clusters; 79 metro, 26 rural (Bexar, Travis and Hidalgo are all metro)
  • 13 very large counties; other counties placed into strata based on(Bexar #28, Austin #37, Hidalgo #70)
    • Metropolitan status
    • Geography (Hidalgo is 1 of 2 on US-Mexico Border)
    • Average number of births per year

(Bexar ~25,000, Hidalgo ~17,000, Travis ~16,000)

    • Race, ethnicity, percent low birth weight

(Hispanic: Bexar ~67%, Hidalgo 96%, Travis 50%)

sites in texas
Sites in Texas

Wave 1 – Bexar

Wave 2 – Hidalgo, Lamar (UTSW), Harris (Baylor)

Wave 3 – Travis, Dallas (UTSW)

??? – Young, Stevenson and Panhandle

study participation
Study Participation
  • Recruit from pre-conception/early pregnancy

¼ prior to conception, ¾ in first trimester (?)

  • Diverse populations: ethnicity,SES, family structure
  • Minimum of 16 in-person home and clinic-based visits (pre-conception through 21)
  • Contact by telephone, computer, mail-in questionnaires every 3 months until 5 years old; then annually
  • Environmental (air, water, soil, dust) samples from child’s environment (home, school, day care)
  • Psychosocial, demographic, neurodevelopmental, neighborhood and contextual data
  • Biological samples from mother, father, child
recruitment of study participants
Recruitment of Study Participants
  • Household Recruitment Approach
  • Supplemented with recruitment through other mechanisms
    • Prenatal care providers
    • Community campaigns
    • Births
  • Alternative approaches that meet the standards of the Study
what will the national children s study mean to children s well being
What Will the National Children’s Study Mean to Children’s Well-Being?
  • Identification of environmental factors which cause or contribute to health, development, and behavior problems
    • Asthma, injury, obesity, autism, ADHD, prematurity…
  • Understanding the biology and genetics of health, development, and behavior
  • Evidence-based information on which to base decisions about practice and policy regarding children’s physical and mental health
  • Economic benefits: cost avoidance
  • Resource for future research
participation incentives
Participation Incentives
  • For the benefit of our children
  • Monetary compensation for time, inconvenience, and expenses
  • Membership and engagement with Study
  • Information about child’s and family’s
    • Health
    • Development
    • Environment
so the national children s study will provide
So, the National Children’s Study Will Provide…
  • The answer to concerns about known exposures during childhood to potential toxicants
  • The power to determine absence of effects or benefit of exposures to various products important for our society
  • Causal factors for a number of diseases and conditions of children with suspected environmental causes
  • How multiple causes interact to result in multiple outcomes
  • Large sample size required to apply knowledge of the human genome to understand multi-factorial genetic conditions
  • Identification of early life factors that contribute to many adult conditions
  • A national resource to answer future questions by using stored biological and environmental samples and the extensive data for decades to come
local issues and opportunities
Local Issues and Opportunities
  • Research opportunities for investigators as ancillary studies are developed
  • Research experience for students/trainees in environmental health, social services, behavioral sciences
  • Job opportunities for graduates – field workers, research assistants, etc.
co investigators
Co-Investigators
  • Obstetrics and Gynecology
    • Donald Dudley, MD
  • Pediatrics
    • Victor German, MD, PhD, Pamela Wood, MD, Nhung Tran, MD
  • Psychiatry
    • Louise O’Donnell, PhD
  • Family and Community Medicine
    • Claudia Miller, MD
  • Medicine
    • Helen Hazuda, PhD
  • Epidemiology and Biostatistics
    • Brad Pollock, PhD
fun thoughts
Fun Thoughts
  • In Bexar County:
    • The first participant will be recruited in 2010.
    • The first participant will be born in 2011
    • The last participant will be recruited in 2013.
    • The last participant will be born in 2014
    • The first participant will be 21 years old in 2032
    • The last participant will be 21 years old in 2035
  • In Travis County
    • The last participant will be 21 years old in 2037
information
Information
  • http://www.nationalchildrensstudy.gov
  • Study Plan
  • Study related materials
  • Study Sites
  • Coordinator
    • (Bexar) Miranda Muzina, MPH
    • (Hidalgo) Ivette Torres
    • (Travis) Judith Livingston