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The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel

This study has been completed.
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00718133
First received: July 17, 2008
Last updated: September 13, 2010
Last verified: September 2010

July 17, 2008
September 13, 2010
December 2008
August 2009   (final data collection date for primary outcome measure)
The prevalence of respiratory symptoms in respect to air pollution [ Time Frame: Two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00718133 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel
The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Bronchial Asthma
  • Signs and Symptoms, Respiratory
  • Allergy
Device: Spirometry (Pony spirometer)
Spirometry at rest
Other Name: Pony spirometer, Cosmed, Italy.
Experimental: 1
Children at school age from Haifa bay region
Intervention: Device: Spirometry (Pony spirometer)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2010
August 2009   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00718133
HTA 4643/ CMC 0066-07
No
Haim Bibi, MD, Carmel Medical Center
Carmel Medical Center
Not Provided
Principal Investigator: Haim Bibi, MD Carmel Medical Center
Carmel Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP