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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 17, 2008

Last Updated Date

March 24, 2009

Start Date ^†

December 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00718133 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

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 Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^†

Bronchial Asthma
Signs and Symptoms, Respiratory
Allergy

Intervention ^†

Device: Spirometry (Pony spirometer)

Study Arms / Comparison Groups

Experimental: Children at school age from Haifa bay region

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

1200

Estimated Completion Date

December 2010

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

6 Years to 12 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Haim Bibi, MD

972-4-8250258

haimb@clalit.org.il

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00718133

Responsible Party

Haim Bibi, MD, Carmel Medical Center

Secondary IDs ^††

grant 3000004504

Study Sponsor ^†

Carmel Medical Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Haim Bibi, MD

Carmel Medical Center

Information Provided By

Carmel Medical Center

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.