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Identifying Residential Hazards Using Home Test Kits

This study has been completed.
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00285532
First received: February 1, 2006
Last updated: November 17, 2014
Last verified: November 2014
History of Changes
  Purpose
The purpose of this project is to help families and communities identify and reduce health risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered with the Better Housing League and Baby's Milk Fund in Cincinnati and nationally with the Alliance to End Childhood Lead Poisoning and the National Center for Lead Safe Housing. The first specific aim of this project is to evaluate a sampling kit for families to assess levels of lead and pesticides in their home environment. This aim will strengthen right-to-know laws by providing families with tools to assess environmental contamination in their own homes. The second aim is to increase community awareness of the role of environmental agents in developmental disorders, hearing loss and school problems.

Condition
Poisoning, Lead

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Pesticides Poisoning
U.S. FDA Resources

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

Primary Outcome Measures:
  • Lead and Pesticide Levels [ Time Frame: One time home visit 3-5 days after distribution of kits ]
Estimated Enrollment: 150
Study Start Date: October 2001
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Home test kit

Detailed Description:

A cross-sectional random, stratified study design will be used for this project. All children who are younger than 5 years of age and have a venipuncture blood sample taken at the babies Milk Fund Clinic will be eligible for this study. After checking the lists for errors and duplications, we will randomly permute the sampling frame, stratifying on children's blood lead concentration. Stratification will be used to enroll about 33% of the sample with blood lead concentrations below 5 mg/dl, 33% between 5 to 10 mg/dl, and 33% of 10 mg/dl or higher. Stratifying the sample will improve our chances of testing the predictive validity of home sampling kits to identify children who have blood lead concentration > 10 mg/dl collected by families. In addition this study will:

  1. Develop a pesticide wipe sampling kit to accompany our lead-sampling kit.
  2. Evaluate the predictive validity of home sampling kits for lead-contaminated floor dust to identify children who have blood lead levels of 10 mg/dl or higher by community participants compared with repeat samples taken by trained, community workers.
  3. Evaluate the reliability of home sampling kits for pesticides in dust collected by community participants compared with trained, community workers.
  4. Disseminate data on the reliability of home sampling tests and provide tools for families to collect environmental samples for large, population-based studies.
  5. Develop a Healthy Homes Resource Center at the Better Housing League to disseminate information to the community about residential hazards.
  Eligibility
Ages Eligible for Study:   3 Months to 5 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children <5 years receiving care via Babies Milk Fund Clinics
Criteria

Inclusion Criteria:

Venous blood lead In residence 3 months Child less than 5 years of age Sampler greater than 18 years of age

Exclusion Criteria:

Cannot read or understand English Physically unable to conduct field sampling Outside of theGreater Cincinnati area

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285532

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0056
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: Sandy M Roda, BS University of Cincinnati
  More Information

ClinicalTrials.gov Identifier: NCT00285532     History of Changes
Other Study ID Numbers: 11261-CP-002 
Study First Received: February 1, 2006
Last Updated: November 17, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Blood Lead
Pesticides
Community-based
Sampling Kits

Additional relevant MeSH terms:
Poisoning
Lead Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 29, 2016