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Respiratory Health Study of Children in Kiryat Tivon

Primary Purpose

Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Minato A 500 AS spirometer
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchial Asthma focused on measuring Asthma, Allergy, Respiratory, Pollution, Children, Air pollution

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All school children Exclusion Criteria: Children that their parents did not signed the informed consent

Sites / Locations

  • Elementary School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

The prevalence of respiratory symptoms in respect to air pollution

Secondary Outcome Measures

Full Information

First Posted
May 28, 2006
Last Updated
June 18, 2008
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00331929
Brief Title
Respiratory Health Study of Children in Kiryat Tivon
Official Title
Respiratory Health Study of Children in Kiryat Tivon
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy
Keywords
Asthma, Allergy, Respiratory, Pollution, Children, Air pollution

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
638 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Cohort of school children that evaluated with questionnaire and spirometry with MINATO 500 JAPAN spirometer
Intervention Type
Device
Intervention Name(s)
Minato A 500 AS spirometer
Other Intervention Name(s)
Spirometer MINATOm AS 500 JAPAn
Intervention Description
Spirometry at rest
Primary Outcome Measure Information:
Title
The prevalence of respiratory symptoms in respect to air pollution
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All school children Exclusion Criteria: Children that their parents did not signed the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Bibi, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elementary School
City
Kiryat Tivon
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15060197
Citation
Schwartz J. Air pollution and children's health. Pediatrics. 2004 Apr;113(4 Suppl):1037-43.
Results Reference
background
Links:
URL
http://www.arb.ca.gov/research/asthma/asthma.htm
Description
air pollution and asthma

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Respiratory Health Study of Children in Kiryat Tivon

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