of

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of Environmental Effects on Child Health and
Development What the NCS Means for UTHSCSA and
San Antonio?
Daniel E. Hale, MD Donald J. Dudley,
MD Pediatrics
Obstetrics and Gynecology University of Texas
Health Sciences Center at San Antonio
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Examples of Environmental Effects in Children

• Lead exposure neuropsychological development
• Prenatal alcohol exposure malformations with
  developmental delay FAS
• Ionizing radiation malignancy leukemia,
  thyroid carcinoma
• Prenatal Pb developmental delay
• Prenatal DES vaginal cancer, male reproductive
  tract abnormalities
• Thalidomide limb defects
• Lack of data on most common current exposures
  outcomes

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Presidents Task Force on Environmental Health
Risks and Safety Risks to Children

• 1998 charge Develop strategies to reduce risk
  of environmental exposures to children
• Co-chairs Secretary HHS, Administrator US EPA
• Members 7 or more cabinet officers Sr. staff
• Many risks not clear or quantified
• Need for additional study of effects of
  environmental exposures (broadly defined)
• Consultation Jan. 2000 endorsed study large,
  bold, multiple agencies, public private
  partnerships
• New money would be required

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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
  pesticides, phthalates, etc
• Existing studies limited in size scope
• Study needed to identify effects or assure safety
• Longitudinal design to infer causality with
  multiple exposures and multiple outcomes

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PL 106-310 Childrens 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.

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Study Concepts

• Longitudinal study of children (to age 21), their
  families and their environment
• National in scope
• Environment defined broadly (chemical, physical,
  behavioral, social, cultural)
• Study common range of environmental exposures
  and less common outcomes (n100,000)
• Environmental genetic interactions
• Use state of the art technology tracking,
  measurement, data analysis

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Priority Outcome Areas (and example hypotheses)

• Undesirable outcomes of pregnancy
• Infection and mediators of inflammation during
  pregnancy are major 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
  -cumulative adverse effects on neurocognitive
  development

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Priority Outcome Areas (and example hypotheses)

• Asthma
• Early bacterial and microbial exposures asthma
  - hygiene hypothesis
• Obesity and physical development
• Impaired glucose metabolism in pregnancy
  obesity and abnormal physical development
• Health
• How does the environment help to determine
  overall health?

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Measures Anticipated - Exposures

• Environmental Samples air, water, dust
• Bio-markers for chemicals blood, breast milk,
  hair, tissue, etc.
• Interview and history
• Serology medical data
• Housing living characteristics
• Family social experiences
• Neighborhood community characteristics
• Projected 2-8 billion samples (total study)

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Measures Anticipated - Outcomes

• Fetal growth outcome of pregnancy
• Birth defects newborn exam
• Growth, nutrition physical development
• Medical condition history illness (e.g.
  asthma), conditions injuries
• Cognitive emotional development
• Mental, developmental behavioral conditions
• Protocol development

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National Sites
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Timeline for UTHSCSA NCS

• We will enroll 250 children per year for 4 years
  in each site.
• First Wave Bexar County
• Organizational Phase 2007-2009
• Enrollment Phase 2009-2012
• Second Wave Hidalgo County
• Organizational Phase 2008-2010
• Enrollment Phase 2010-2013
• Third Wave Travis County
• Organizational Phase 2009-2011
• Enrollment Phase 2011-2014

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UTHSCSA Staff
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UTHSCSA Budget by Year
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Other Potential Sites in Texas
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Discussion

• Excellent opportunity for access to a large
  dataset
• Excellent training opportunity for fellows and
  junior faculty
• Mechanism for Adjunct Studies is available and
  applications encouraged
• Reviewed by Program Office
• Participant burden is major consideration
• Adjunct Studies will require funding external to
  NCS budget
• Potential for local datasets and evaluation