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NCT00331929 Clinical Trial

Respiratory Health Study of Children in Kiryat Tivon

Allergy Clinical Trial

Official title:
Respiratory Health Study of Children in Kiryat Tivon

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00331929
Other study ID # Ped-2/2006
Secondary ID HTA 3653CMC 0601
Status Completed
Phase N/A
First received May 28, 2006
Last updated June 18, 2008
Start date September 2006
Est. completion date December 2007

Study information
Verified date December 2007
Source Carmel Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 638
Est. completion date December 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

- All school children

Exclusion Criteria:

- Children that their parents did not signed the informed consent

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Minato A 500 AS spirometer
Spirometry at rest

Locations
Country Name City State
Israel Elementary School Kiryat Tivon

Sponsors (1)
Lead Sponsor Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Schwartz J. Air pollution and children's health. Pediatrics. 2004 Apr;113(4 Suppl):1037-43. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The prevalence of respiratory symptoms in respect to air pollution 1.5 years No
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