Respiratory Health Study of Children in Kiryat Tivon

June 18, 2008 updated by: Carmel Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

638

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kiryat Tivon, Israel
        • Elementary school

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All school children

Exclusion Criteria:

  • Children that their parents did not signed the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The prevalence of respiratory symptoms in respect to air pollution
Time Frame: 1.5 years
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Haim Bibi, MD, Carmel Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 28, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (Estimate)

May 31, 2006

Study Record Updates

Last Update Posted (Estimate)

June 20, 2008

Last Update Submitted That Met QC Criteria

June 18, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ped-2/2006
  • HTA 3653
  • CMC 06013904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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