Clinical trial NCT00718133: The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel
Official title: The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel.
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: 15
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 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
country: Israel
facility: Pediatric Center Armon Clinic
Study officials:
affiliation: Carmel Medical Center
name: Haim Bibi, MD
role: PRINCIPAL_INVESTIGATOR
References: