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Sponsored by: |
Carmel Medical Center |
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Information provided by: | Carmel Medical Center |
ClinicalTrials.gov Identifier: | NCT00717899 |
Haifa bay region is located close to a major industrial zone. The aim of the study is to evaluate the health status of school children living in Haifa bay region.The health status will be evaluated using health questionnaires and spirometry.
Condition | Intervention |
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Bronchial Asthma Signs and Symptoms, Respiratory Allergy |
Device: Spirometry (Pony spirometer) |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region |
Estimated Enrollment: | 1200 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
School children from Haifa bay region, Israel.
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Device: Spirometry (Pony spirometer)
Spirometry at rest
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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.
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Haim Bibi, MD | 972-4-8250258 | haimb@clalit.org.il |
Israel | |
Schools at the Haifa Bay region, Israel. | |
Haifa Bay, Israel |
Principal Investigator: | Haim Bibi, MD | Carmel Medical Center, Haifa, Israel |
Responsible Party: | Carmel Medical Center ( Haim Bibi, MD ) |
Study ID Numbers: | HTA 4642/ CMC 0064-07, grant 3000004504 |
Study First Received: | July 17, 2008 |
Last Updated: | September 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00717899 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Asthma Allergy Respiratory |
Pollution Children Air pollution |
Signs and Symptoms Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Signs and Symptoms, Respiratory Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |