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

NCT ID: NCT00718133

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Bronchial Asthma Signs and Symptoms, Respiratory Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Children at school age from Haifa bay region

Group Type EXPERIMENTAL

Spirometry (Pony spirometer)

Intervention Type DEVICE

Spirometry at rest

Interventions

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Spirometry (Pony spirometer)

Spirometry at rest

Intervention Type DEVICE

Other Intervention Names

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Pony spirometer, Cosmed, Italy.

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Carmel Medical Center

Principal Investigators

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Haim Bibi, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

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Pediatric Center Armon Clinic

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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HTA 4643/ CMC 0066-07

Identifier Type: -

Identifier Source: org_study_id