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The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
This study is not yet open for participant recruitment.
Verified by Carmel Medical Center, July 2008
Sponsored by: Carmel Medical Center
Information provided by: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00717899
  Purpose

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
Bronchial Asthma
Signs and Symptoms, Respiratory
Allergy
Device: Spirometry (Pony spirometer)

MedlinePlus related topics: Air Pollution Allergy Asthma
U.S. FDA Resources
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

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • The prevalence of respiratory symptoms in respect to air pollution [ Time Frame: Two years ] [ Designated as safety issue: No ]

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
1: Experimental
School children from Haifa bay region, Israel.
Device: Spirometry (Pony spirometer)
Spirometry at rest

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717899

Contacts
Contact: Haim Bibi, MD 972-4-8250258 haimb@clalit.org.il

Locations
Israel
Schools at the Haifa Bay region, Israel.
Haifa Bay, Israel
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Haim Bibi, MD Carmel Medical Center, Haifa, Israel
  More Information

Related Info  This link exits the ClinicalTrials.gov site

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

Keywords provided by Carmel Medical Center:
Asthma
Allergy
Respiratory
Pollution
Children
Air pollution

Study placed in the following topic categories:
Signs and Symptoms
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Signs and Symptoms, Respiratory
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009