The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel
| Tracking Information | |||||
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| First Received Date ICMJE | July 17, 2008 | ||||
| Last Updated Date | September 13, 2010 | ||||
| Start Date ICMJE | December 2008 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The prevalence of respiratory symptoms in respect to air pollution [ Time Frame: Two years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00718133 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel | ||||
| Official Title ICMJE | The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel. | ||||
| Brief Summary | Haifa bay region 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 using health questionnaires and spirometry. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Spirometry (Pony spirometer)
Spirometry at rest
Other Name: Pony spirometer, Cosmed, Italy. |
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| Study Arm (s) | Experimental: 1
Children at school age from Haifa bay region
Intervention: Device: Spirometry (Pony spirometer) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00718133 | ||||
| Other Study ID Numbers ICMJE | HTA 4643/ CMC 0066-07 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Haim Bibi, MD, Carmel Medical Center | ||||
| Study Sponsor ICMJE | Carmel Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Carmel Medical Center | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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