Respiratory Health Study of Children in Kiryat Tivon

This study has been completed.
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00331929
First received: May 28, 2006
Last updated: June 18, 2008
Last verified: December 2007

May 28, 2006
June 18, 2008
September 2006
September 2007   (final data collection date for primary outcome measure)
The prevalence of respiratory symptoms in respect to air pollution [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
The prevalence of respiratory symptoms in respect to air pollution
Complete list of historical versions of study NCT00331929 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Respiratory Health Study of Children in Kiryat Tivon
Respiratory Health Study of Children in Kiryat Tivon

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Bronchial Asthma
  • Signs and Symptoms, Respiratory
  • Allergy
Device: Minato A 500 AS spirometer
Spirometry at rest
Other Name: Spirometer MINATOm AS 500 JAPAn
Experimental: A
Cohort of school children that evaluated with questionnaire and spirometry with MINATO 500 JAPAN spirometer
Intervention: Device: Minato A 500 AS spirometer
Schwartz J. Air pollution and children's health. Pediatrics 2004;113(4 Suppl):1037-43.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
638
December 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All school children

Exclusion Criteria:

  • Children that their parents did not signed the informed consent
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00331929
Ped-2/2006, HTA 3653, CMC 06013904
Yes
Haim Bibi, Carmel Medical Center
Carmel Medical Center
Not Provided
Principal Investigator: Haim Bibi, MD Carmel Medical Center
Carmel Medical Center
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP