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
  Purpose

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.


Condition Intervention
Bronchial Asthma
Signs and Symptoms, Respiratory
Allergy
Device: Minato A 500 AS spirometer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Respiratory Health Study of Children in Kiryat Tivon

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • The prevalence of respiratory symptoms in respect to air pollution [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 638
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Spirometer MINATOm AS 500 JAPAn

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All school children

Exclusion Criteria:

  • Children that their parents did not signed the informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331929

Locations
Israel
Elementary School
Kiryat Tivon, Israel
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Haim Bibi, MD Carmel Medical Center
  More Information

Additional Information:
Publications:
Schwartz J. Air pollution and children's health. Pediatrics 2004;113(4 Suppl):1037-43.

Responsible Party: Haim Bibi, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00331929     History of Changes
Other Study ID Numbers: Ped-2/2006, HTA 3653, CMC 06013904
Study First Received: May 28, 2006
Last Updated: June 18, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Carmel Medical Center:
Asthma
Allergy
Respiratory
Pollution
Children
Air pollution

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Signs and Symptoms
Signs and Symptoms, Respiratory
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 21, 2014