Clinical trial NCT00717899: The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
Official title: The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Asthma
Signs and Symptoms, Respiratory
Allergy
Keywords: Asthma
Allergy
Respiratory
Pollution
Children
Air pollution
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2008-07-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Haifa bay region is located close to a major industrial zone. The aim of the study is to evaluate the health status of school children living in Haifa bay region.The health status will be evaluated using health questionnaires and spirometry.

Detailed description: Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region.

The health status will be evaluated while using health questionnaires and spirometry.

Objective: To evaluate the respiratory health of Haifa bay region children with comparatives, with respect to local air pollution levels.

Material and Methods: Children from Haifa bay region from 10 different communities (1200 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 The health status of the children will be documented from the children's primary clinic files as well.

Eligibility criteria: Inclusion Criteria:

* Living in Haifa bay region, Israel.
* Parents signed informed consent.

Exclusion Criteria:

* Children that their parents did not signed the informed consent
* Chronic disease except of asthma: Diabetes mellitus, Cystic Fibrosis, Cardiac diseases, Renal, Rheumatic and Chronic Gastrointestinal diseases, Mental retardation.

Primary outcomes:
measure: The prevalence of respiratory symptoms in respect to air pollution
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa Bay
country: Israel
facility: Schools at the Haifa Bay region, Israel.
Study officials:
affiliation: Carmel Medical Center, Haifa, Israel
name: Haim Bibi, MD
role: PRINCIPAL_INVESTIGATOR
References: