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A Longitudinal Study of Environmental Effects on Child Health and Development

A Longitudinal Study of Environmental Effects on Child Health and Development Duane Alexander, M.D. U.S. Department of Health and Human Services NICHD, CDC, NIEHS U.S. Environmental Protection Agency. Children have increased vulnerability to environmental exposures.

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A Longitudinal Study of Environmental Effects on Child Health and Development

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  1. A Longitudinal Study of Environmental Effects on Child Health and Development Duane Alexander, M.D. U.S. Department of Health and Human Services NICHD, CDC, NIEHS U.S. Environmental Protection Agency

  2. Children have increased vulnerability to environmental exposures • Critical windows of vulnerability during development • Immature mechanisms for detoxification and protection • Differences in metabolism and behavior that may yield higher exposure in the same environments

  3. Known exposures of concern, and examples • Biological • Infection in early life • Metabolic • Physical • Built environment • Radiation • Psychosocial • Abuse and neglect • Family structure • Diet & Drugs • Food additives • Pharmaceuticals • Chemical • Heavy metals • Pesticides

  4. Current Known Exposure Levels2nd National Report on Human Exposure to Environmental Chemicals* *http://www.cdc.gov/exposurereport/pdf/SecondNER.pdf

  5. Birth Defects Prematurity Autism Cerebral Palsy Type I diabetes Mental retardation Obesity Cancer Asthma Injuries Schizophrenia Learning disabilities Important childhood conditions with suspected environmental components

  6. President’s Task Force on Environmental Health Risks and Safety Risks to Children • Charged to develop strategies to reduce risk of environmental exposures to children • Co-chairs – Secretary HHS, Administrator USEPA • Conclusions • Many risks to children are poorly characterized • Need for longitudinal study of environmental effects • New money would be required to carry out the study

  7. Rationale • Converging factors • Increased vulnerability to environmental exposures in children in general • Exposures to some agents have caused serious developmental effects – lead, alcohol • Known current exposures of high frequency – • Existing research too limited in size & scope to answer the questions • Study needed to identify what is harmful, harmless and helpful to child development • Life-course design to correctly link with multiple exposures and multiple outcomes

  8. PL 106-310 Children’s Health Act of 2000 (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.

  9. Study Concepts • Longitudinal study of children, their families and their environment • National in scope • Environment defined broadly (chemical, physical, behavioral, social, cultural) • Study of sufficient size to identify causal factors for important but less common outcomes (approx. 100,000 participants) • Application of the human genome project

  10. Study Concepts (con’t) • State-of-the-art technology – tracking, measurement, data management • Consortium of multiple agencies • Extensive public-private partnerships • Hypothesis driven • National resource for future studies

  11. Criteria for Core Hypotheses • No single hypothesis • Hypothesis required for costly elements • Important for child health & development (prevalence, severity, morbidity, mortality, disability, cost, public health significance) • Reasonable scientific rationale • Require the large sample size (~100,000) • Measurable with study of this size • Requires longitudinal follow-up

  12. Priority Outcome Areas (and example hypotheses) • Undesirable outcomes of pregnancy(Infection and mediators of inflammation during pregnancy are major causal factors associated with pre-term birth) • Neurobehavioral development (Low level pesticide exposure in utero is associated with impaired neurobehavioral and cognitive performance) • Injury (Repeated head trauma w/o anatomic damage is a causal factor for cumulative adverse effects on neurocognitive development)

  13. Priority Outcome Areas (and example hypotheses) • Asthma (maternal stress during pregnancy is associated with the prevalence and severity of asthma in offspring) • Obesity and physical development (Obesity and insulin resistance is associated with impaired glucose metabolism in pregnancy, intrauterine growth restriction, and interacting factors in the physical and social environment)

  14. Proposed Drug Abuse Hypotheses • Prenatal exposure to drugs will interact with family, child and other factors to influence cognitive, social/emotional and physical development. • Initiation of drug use, transition to abuse and addiction, and physical and mental consequences of drug use are influenced by certain environmental exposures including parent, child, and other factors.

  15. Associations and Interactions in the National Children’s Study Chemical Expos. Asthma Infection Birth Defects Gene expression Social Environ Development & Behavior Physical Environ Health Care Growth Medicine & Pharm Fertility & Pregnancy

  16. Measures Anticipated - Exposures • Environmental Samples: air, water, dust • Bio-markers for chemicals: blood, breast milk, hair, tissue, etc. • Interview and history • Serology and medical data • Housing & living characteristics • Family and social experiences • Neighborhood and community characteristics

  17. Measures Anticipated –Outcomes • Fetal growth and outcome of pregnancy • Birth defects and newborn exam • Growth, nutrition and physical development • Medical condition and history: illness (e.g. asthma), conditions, & injuries • Cognitive and emotional development • Mental, developmental and behavioral conditions

  18. Use of Data to Maximize Output • Results available beginning 2008 • Targeted hypotheses-testing analyses • Successive public-use data sets with support • Successive funding for investigator initiated research and analyses • Expected translation of results into related prevention initiatives

  19. National Children’s Study Organization of Planning Phase -Extensive multi-agency collaboration -Broad scientific and advocacy input • Interagency leadership and funding – HHS (NICHD, NIEHS, CDC) & EPA • Dedicated staff at NICHD for operations • Federal Consortium of all HHS agencies + 12 other Departments and independent agencies • Chartered Federal Advisory Committee for advice and peer review • Working Groups (20) with approx. 250 scientists and experts for consultation and guidance re: hypotheses, design, measures • Network of all interested parties, 2,000+

  20. Projected Time Line 2000-2004 Planning, pilot studies, gather input 2001-2002 Form advisory committee and working groups 2003 Finalize central hypotheses, develop study design 2004 Select NCS study sites across the U.S. 2005 Begin participant enrollment 2008 First research results available 2008-2030+ Results continue; Translate into disease prevention strategies

  21. Expected Benefits of the NCS

  22. The NCS will provide • The answer to concerns about known exposures during childhood to potential toxicants • The power todetermine absence of effects or benefit of exposures to various products important for our economy • Causal factors for a number of diseases and conditions of children with suspected environmental causes • How multiple causesinteract to result inmultiple outcomes • Large sample size required to apply knowledge of the human genome to understand multifactoral 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

  23. Contact information • Web site: http://NationalChildrensStudy.gov E mail: ncs@mail.nih.gov

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