- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00717899
The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
Study Overview
Status
Intervention / Treatment
Detailed Description
Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region.
The health status will be evaluated while using health questionnaires and spirometry.
Objective: To evaluate the respiratory health of Haifa bay region children with comparatives, with respect to local air pollution levels.
Material and Methods: Children from Haifa bay region from 10 different communities (1200 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form.
First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be filled in by the parents.
Second step: Spirometry checking of the children. In parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the Haifa District Municipality Association for the Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation window. Additional meteorological data are also collected.
Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region.
The prevalence of pulmonary disease will be evaluated according to the risk maps The health status of the children will be documented from the children's primary clinic files as well.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Haifa Bay, Israel
- Schools at the Haifa Bay region, Israel.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Living in Haifa bay region, Israel.
- Parents signed informed consent.
Exclusion Criteria:
- Children that their parents did not signed the informed consent
- Chronic disease except of asthma: Diabetes mellitus, Cystic Fibrosis, Cardiac diseases, Renal, Rheumatic and Chronic Gastrointestinal diseases, Mental retardation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
School children from Haifa bay region, Israel.
|
Spirometry at rest
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The prevalence of respiratory symptoms in respect to air pollution
Time Frame: Two years
|
Two years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Haim Bibi, MD, Carmel Medical Center, Haifa, Israel
Publications and helpful links
Helpful Links
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
- HTA 4642/ CMC 0064-07
- 3000004504 (Grant) (Other Grant/Funding Number: 3000004504)
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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