Cincinnati Children's Environmental Health Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT00129324
The goal of the HOME Study is to quantify the impact of low-level fetal and early childhood exposures to environmental toxicants including lead, mercury, and other metals, pesticides, polychlorinated biphenyls (PCBs), persistent organic pollutants (PBDEs/PFCs), phthalates, phenols, environmental tobacco smoke, and alcohol on child development, neurobehavior, health, and growth. 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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
This study aims to examine the effects of low-level exposures to prevalent neurotoxicants on health, growth, and neurobehavior among a representative sample of children. Pregnant women were enrolled in the project around 16 weeks of gestation. In the first phase of the study, we followed children resulting from the pregnancy through the age of 36 months. The second phase extended follow-up through 72 months. Phase 3 extended follow-up to 8 years (range 7.5-10) with comprehensive neurobehavioral assessments. Phase 4 will allow follow-up at 12 years (range 11-13), and includes measures of health, growth and body composition, behavior and mental health, and neuroimaging. To address the potential adverse health risks of environmental chemicals, including persistent pollutants such as PBDEs and PFCs and other non-persistent chemicals, on fetal, infant, and child neurobehavior, the investigators are systematically examining their associations with endocrine function, cognition, learning and memory, motor skills, attention and executive function, and behavior from age 1 to 7.5-10 years. The investigators are also examining exposures at different developmental stages (in utero at 16 weeks of gestation, early childhood, school age, preadolescence) using stored biological samples and measure child neurobehavior at 1, 2, 3, 4, 5, 8, and 12 years. This longitudinal study will allow the investigators to determine the dose response, windows of susceptibility, and persistence of the association. The investigators are also examining the contribution of PBDE exposures from house dust in a subset of children who have complete sets of samples of maternal serum and child serum collected from annual visits along with extensive measures of mouthing behaviors.
Hypotheses from the four phases of the study are as follows:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prior to their child's birth, participants randomized to Lead Reduction Group received lead hazard reduction controls to reduce residential exposure to lead.
Between 3 and 6 months of age, participants randomized to Injury Reduction Arm received injury hazard controls to reduce the number of residential injuries.
Time frame: 16wk & 26wk gestation, birth, annually at 1y-12y
Testing the efficacy of lead reduction controls in the homes of participants. Examining the effects of low level blood lead concentration on child development and neurobehavior. Measures of blood lead concentration were taken from mothers prenatally at approximately 16 and 26 weeks gestation, from cord blood at birth, and annually from participating children from 1 - 10 years of age.
Time frame: 16wk & 26wk gestation, birth, 4wk postnatal, annually years 1-12.
Addressing potential adverse health risks of environmental chemicals (persistent organic pollutants, metals, cotinine, pesticides, flame retardants, BPA, and phthalates) on fetal, infant, and child neurobehavior. Examining their associations with endocrine function, body composition (DXA), neuroimaging (MRI/fMRI), cognition, learning and memory, motor skills, attention and executive function, behavior, and mental health. Also examining exposures at different developmental stages and measuring child neurobehavior.
Time frame: Postnatally up to age 5 years
Test the efficacy of injury reduction controls in the homes of study participants. Assessed homes for potential injury hazards and installed child safety equipment. Collected parent report of injury events and validated the events against injuries tracked in the Hamilton County Injury Surveillance System
National Institute of Environmental Health Sciences (NIEHS)
Nih
Neurobehavioral Effects of Prevalent Neurotoxicants in Children: A Cohort Study of the Cincinnati Center for Children's Environmental Health
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