Respiratory Health Study of Children in Kiryat Tivon

Sponsor

Carmel Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00331929

Collaborator

(none)

638

Enrollment

Location

Arm

Duration (Months)

42.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.

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: Minato A 500 AS spirometer	N/A

Detailed Description

Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.

The health status will be evaluated while using health questionnaires and spirometry.

Objective: To evaluate the respiratory health of K. Tivon children with comparatives, with respect to local air pollution levels.

Material and Methods: All the school children from K. Tivon (1800 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

638 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Respiratory Health Study of Children in Kiryat Tivon

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Cohort of school children that evaluated with questionnaire and spirometry with MINATO 500 JAPAN spirometer	Device: Minato A 500 AS spirometer Spirometry at rest Other Names: Spirometer MINATOm AS 500 JAPAn

Arm

Intervention/Treatment

Experimental: A

Cohort of school children that evaluated with questionnaire and spirometry with MINATO 500 JAPAN spirometer

Device: Minato A 500 AS spirometer

Spirometry at rest

Other Names:

Spirometer MINATOm AS 500 JAPAn