- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285532
Identifying Residential Hazards Using Home Test Kits
Study Overview
Status
Conditions
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:
- Develop a pesticide wipe sampling kit to accompany our lead-sampling kit.
- 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.
- Evaluate the reliability of home sampling kits for pesticides in dust collected by community participants compared with trained, community workers.
- Disseminate data on the reliability of home sampling tests and provide tools for families to collect environmental samples for large, population-based studies.
- Develop a Healthy Homes Resource Center at the Better Housing League to disseminate information to the community about residential hazards.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45267-0056
- University of Cincinnati
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Home test kit
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lead and Pesticide Levels
Time Frame: One time home visit 3-5 days after distribution of kits
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One time home visit 3-5 days after distribution of kits
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Collaborators and Investigators
Investigators
- Principal Investigator: Sandy M Roda, BS, University of Cincinnati
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11261-CP-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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