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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718133
• Other study ID #: HTA 4643/ CMC 0066-07
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: September 13, 2010
• Start date: December 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergy
• Asthma
• Bronchial Asthma
• Signs and Symptoms
• Signs and Symptoms, Respiratory

Intervention

Device:
• Spirometry (Pony spirometer)
Spirometry at rest

Locations

Country	Name	City	State
Israel	Pediatric Center Armon Clinic	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of respiratory symptoms in respect to air pollution		Two years	No