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

Sponsor

Carmel Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00718133

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bronchial Asthma Signs and Symptoms, Respiratory Allergy	Device: Spirometry (Pony spirometer)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Children at school age from Haifa bay region	Device: Spirometry (Pony spirometer) Spirometry at rest Other Names: Pony spirometer, Cosmed, Italy.

Arm

Intervention/Treatment

Experimental: 1

Children at school age from Haifa bay region

Device: Spirometry (Pony spirometer)

Spirometry at rest

Other Names:

Pony spirometer, Cosmed, Italy.

Outcome Measures

Primary Outcome Measures

The prevalence of respiratory symptoms in respect to air pollution [Two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.