Identifying Residential Hazards Using Home Test Kits

Poisoning, Lead Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285532
• Other study ID #: 11261-CP-002
• Status: Completed
• Phase: N/A
• First received: February 1, 2006
• Last updated: November 17, 2014
• Start date: October 2001
• Est. completion date: October 2006

Study information

• Verified date: November 2014
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Lead Poisoning
• Poisoning, Lead

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead and Pesticide Levels		One time home visit 3-5 days after distribution of kits