The goal of the HOME Study is to quantify the impact of low-level fetal and early childhood exposures to environmental toxicants (lead, mercury, pesticides, PCBs, environmental tobacco smoke, and alcohol) on child development (cognition, behavior, growth, and hearing). The HOME Study will also evaluate meconium as a biomarker for fetal exposure and test the effectiveness of home repairs to control lead hazards and injuries in early childhood.

Condition	Intervention
Environmental Exposures Environmental Monitoring Child Development	Procedure: Lead Hazard Control Intervention  Procedure: Injury Hazard Control Intervention

Further Study Details: 

Primary Outcomes: Blood Lead Concentration; Child Development/Behavioral Problems; IQ Scores; Hearing; Residential Injuries
Expected Total Enrollment:  400

Objectives/Hypothesis: Epidemiologic and experimental data have established the adverse effects of numerous environmental toxicants, including lead, alcohol, mercury, PCB’s and environmental tobacco smoke (ETS), on children’s brain function. In utero exposure to these toxicants has been linked with cognitive deficits and behavioral problems. Lead exposure has been linked to specific behavioral problems, including conduct disorder and delinquency, and exposure to lead and ETS have been linked with mental retardation and ADHD-like features. Still, many studies linking environmental toxicants with neurobehavioral effect have only examined children with high exposures; there is emerging evidence that adverse effect of exposure to lead, mercury, and PCB’s occur at levels previously thought to be low. There is also data linking exposures to pesticides with adverse neurobehavioral effects, but the data are too sparse to draw any conclusions.

The ideal biomarkers for measuring in utero exposure to specific toxicants have not been established. Fetal exposure is typically measured with surveys, maternal blood, urine or hair. Meconium - a chronic measure of in utero exposure - has only been validated as a measure of cocaine and ETS exposure, but it offers numerous advantages, including a non-invasive method to simultaneously test for exposure to numerous toxicants. Still, it is unclear, whether conventional biomarkers or meconium is more predictive of the adverse effects associated with specific toxicants. For lead exposure, emerging data indicate that we should emphasize primary prevention, but the safety and efficacy of lead hazard controls are uncertain, especially for children with lower blood lead concentrations. We are testing the following hypotheses:

1. In utero exposures measured by survey (alcohol and ETS), maternal and cord blood (lead and mercury) maternal and cord serum (ETS), and urine (pesticides) are less predictive of in utero effects of prevalent toxicants, including cognition, behavior problems, growth and hearing, compared with the same toxicants in meconium.
2. Prenatal and postnatal exposures to prevalent pesticides and ETS are associated with adverse neurobehavioral effects, growth delay and hearing loss in children.
3. Children in the Lead Hazard Reduction Group will have blood lead concentration that are 2.7 mcg/dL (30%) or lower at 36 months of age, significantly higher cognitive scores, less hearing loss, greater growth velocity, and fewer behavioral problems and developmental disorders, compared with those in the Control Group.

Approach: We are conducting a longitudinal cohort study to examine the dose-response of low-level exposures (pre- and postnatal) to prevalent neurotoxins with neurobehavioral outcomes and specific development conditions, including conduct disorder and behaviors consistent with ADHD. We will also conduct a nested, randomized controlled trial to test the efficacy of lead hazard controls on blood lead concentrations and developmental conditions and the efficacy of injury hazard controls on injury incidence and severity.

Expected Results: This trial would be the first to attempt to validate meconium as a measure of exposure to numerous neurotoxicants and to test the efficacy of a residential lead and injury hazard control on blood lead concentration, neurobehavioral functioning, and injury incidence and severity.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• pregnancy
• participating prenatal practice/clinic
• participating hospital

Exclusion Criteria:

• residence outside study area
• plans to move outside study area within 1 year
• home built after 1978
• less than 18 years of age
• beyond 19 weeks of gestation
• diagnosis of diabetes
• diagnosis of seizure disorder (taking anti-seizure medication)
• diagnosis of thyroid disorder
• diagnosis of AIDS or positive HIV test
• diagnosis of bipolar disorder
• diagnosis of schizophrenia
• diagnosis of cancer resulting in radiation treatment or chemotherapy

Please refer to this study by ClinicalTrials.gov identifier  NCT00129324

Bruce P Lanphear, MD, MPH      513-636-3778    bruce.lanphear@cchmc.org

Ohio
      Cincinnati Children''''s Environmental Health Center, Cincinnati,  Ohio,  45229,  United States; Recruiting

Study chairs or principal investigators

Bruce P Lanphear, MD, MPH,  Principal Investigator,  Children''''s Hospital Medical Center - Cincinnati   

Study ID Numbers:  11261-CP-001
Last Updated:  August 18, 2005
Record first received:  August 10, 2005
ClinicalTrials.gov Identifier:  NCT00129324
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23