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

This study has been completed.
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00717899
First received: July 17, 2008
Last updated: September 13, 2010
Last verified: September 2010
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region

Resource links provided by NLM:


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: December 2008
Study Completion Date: September 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
School children from Haifa bay region, Israel.
Device: Spirometry (Pony spirometer)
Spirometry at rest
Other Name: Pony spirometer, Cosmed, Italy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Haim Bibi, MD, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00717899     History of Changes
Other Study ID Numbers: HTA 4642/ CMC 0064-07, 3000004504 (Grant)
Study First Received: July 17, 2008
Last Updated: September 13, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Signs and Symptoms
Signs and Symptoms, Respiratory
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 23, 2014