HOME Study (Health Outcomes and Measures of the Environment Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00129324
First received: August 10, 2005
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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, polychlorinated biphenyls (PCBs), persistent organic pollutants (PBDEs/PFCs), environmental tobacco smoke, and alcohol on child development, neurobehavior 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Neurobehavioral Effects of Prevalent Neurotoxicants in Children: A Cohort Study of the Cincinnati Center for Children's Environmental Health

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Primary Outcome Measures:
  • Lead reduction intervention, blood lead concentrations & neurobehavioral outcomes [ Time Frame: 16wk & 26wk gestation, birth, annually at 1y-10y ] [ Designated as safety issue: Yes ]
    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.

  • Exposure to environmental chemicals and their effects on child health, neurobehavior and development [ Time Frame: 16wk & 26wk gestation, birth, 4wk postnatal, annually years 1-10. ] [ Designated as safety issue: No ]
    Addressing potential adverse health risks of environmental chemicals (persistent organic pollutants, metals, cotinine, pesticides, BPA, and phthalates) on fetal, infant, and child neurobehavior. Examining their associations with endocrine function, cognition, learning and memory, motor skills, attention and executive function, and behavior. Also examining exposures at different developmental stages and measuring child neurobehavior.

  • Injury prevention measures and household injuries [ Time Frame: Postnatally up to age 5 years ] [ Designated as safety issue: Yes ]
    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


Enrollment: 468
Study Start Date: March 2003
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lead Reduction Arm
random assignment to receive lead hazard control intervention. Assessing lead hazards in the home. Reducing lead hazards by cleaning, painting, covering, and/or replacing/repairing interior and exterior components of the home.
Procedure: Lead Hazard Control Intervention
Prior to their child's birth, participants randomized to Lead Reduction Group received lead hazard reduction controls to reduce residential exposure to lead.
Injury Reduction Arm
random assignment to receive injury hazard control intervention. Assessing home for potential injury hazards. Controlling hazards by 1) installing safety equipment such as stairway gates, cabinet locks, smoke & CO detectors, etc. 2) removing the hazards from the reach of a child and/or 3) restricting access to the hazards.
Procedure: Injury Hazard Control Intervention
Between 3 and 6 months of age, participants randomized to Injury Reduction Arm received injury hazard controls to reduce the number of residential injuries.

Detailed Description:

This study aims to examine the effects of low-level exposures to prevalent neurotoxicants on health, cognitive development, and behavior problems among a representative sample of children. Pregnant women were enrolled in the project during pregnancy. 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 extends follow-up between age 7.5 years to 10 years with comprehensive neurobehavioral assessments. 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, ages 3, 5, and 7.5-10 years) using stored biological samples and measure child neurobehavior at 1, 2, 3, 4, 5, and 7.5-10 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 three phases of the study are as follows:

  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, and growth compared with the same toxicants in meconium.
  2. Prenatal and postnatal exposures to prevalent pesticides and ETS are associated with adverse neurobehavioral effects, and growth delay in children.
  3. Higher lead exposure, measured during pregnancy and early childhood using maternal blood, cord blood, meconium and children's blood, will be associated with lower IQ scores and more behavioral problems for children with a maximal blood lead level < 5 mg/dL.
  4. Children in the lead treatment arm will have: blood lead that is 2.7 mg/dL lower, higher IQ scores, greater growth velocity, and fewer behavioral problems than children in the control group.
  5. Levels of lead in dust, soil and water will be significantly lower for housing units in the lead treatment arm compared with the injury control arm at 36 and 48 month home visits.
  6. A multifactorial, housing intervention will reduce residential injury by 30 percent among children in the injury treatment arm compared with those in the lead treatment arm.
  7. Prenatal and Postnatal exposures to PBDEs and PFCs are associated with altered thyroid hormone levels and deficits in infant and child neurobehavior
  8. With increasing child age, PBDE exposure from household dust becomes a stronger predictor of child serum PBDE concentration than exposure from placenta or breast milk.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129324

Locations
United States, Ohio
Cincinnati Children's Environmental Health Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Investigators
Principal Investigator: Bruce P Lanphear, MD, MPH Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Publications:

Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00129324     History of Changes
Other Study ID Numbers: 11261-CP-001, R01ES014575, PO1ES011261, R01ES020349
Study First Received: August 10, 2005
Last Updated: March 21, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
HOME
Environmental Exposure
Neurobehavior
Child Development
Lead Exposure
Child Injury

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014