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| Sponsored by: |
Carmel Medical Center |
|---|---|
| Information provided by: | Carmel Medical Center |
| ClinicalTrials.gov Identifier: | NCT00331929 |
Purpose
Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.
The health status will be evaluated using health questionnaires and spirometry.
| Condition | Intervention |
|---|---|
|
Bronchial Asthma Signs and Symptoms, Respiratory Allergy |
Device: Minato A 500 AS spirometer |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Respiratory Health Study of Children in Kiryat Tivon |
| Enrollment: | 638 |
| Study Start Date: | September 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Cohort of school children that evaluated with questionnaire and spirometry with MINATO 500 JAPAN spirometer
|
Device: Minato A 500 AS spirometer
Spirometry at rest
|
Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.
The health status will be evaluated while using health questionnaires and spirometry.
Objective: To evaluate the respiratory health of K. Tivon children with comparatives, with respect to local air pollution levels.
Material and Methods: All the school children from K. Tivon (1800 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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Carmel Medical Center ( Haim Bibi ) |
| Study ID Numbers: | Ped-2/2006, HTA 3653, CMC 06013904 |
| Study First Received: | May 28, 2006 |
| Last Updated: | June 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00331929 |
| 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 |
