Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT00285532
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2006-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identifying Residential Hazards Using Home Test Kits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007855', 'term': 'Lead Poisoning'}], 'ancestors': [{'id': 'D000075322', 'term': 'Heavy Metal Poisoning'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2006-02-01', 'studyFirstSubmitQcDate': '2006-02-01', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lead and Pesticide Levels', 'timeFrame': 'One time home visit 3-5 days after distribution of kits'}]}, 'conditionsModule': {'keywords': ['Blood Lead', 'Pesticides', 'Community-based', 'Sampling Kits'], 'conditions': ['Poisoning, Lead']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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:\n\n1. Develop a pesticide wipe sampling kit to accompany our lead-sampling kit.\n2. 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.\n3. Evaluate the reliability of home sampling kits for pesticides in dust collected by community participants compared with trained, community workers.\n4. Disseminate data on the reliability of home sampling tests and provide tools for families to collect environmental samples for large, population-based studies.\n5. Develop a Healthy Homes Resource Center at the Better Housing League to disseminate information to the community about residential hazards."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children \\<5 years receiving care via Babies Milk Fund Clinics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nVenous blood lead In residence 3 months Child less than 5 years of age Sampler greater than 18 years of age\n\nExclusion Criteria:\n\nCannot read or understand English Physically unable to conduct field sampling Outside of theGreater Cincinnati area'}, 'identificationModule': {'nctId': 'NCT00285532', 'briefTitle': 'Identifying Residential Hazards Using Home Test Kits', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Environmental Health Sciences (NIEHS)'}, 'orgStudyIdInfo': {'id': '11261-CP-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Home test kit'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267-0056', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Sandy M Roda, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}}}}