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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03788330
Other study ID # XFGY001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2018
Est. completion date January 22, 2019

Study information

Verified date March 2019
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air ventilation system with no filtration and natual ventilation will be compared on the effects of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be collected to investigate the associations between indoor air pollution and biomarkes of certain health effects.


Description:

A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air system with no filtration and 3) natural ventilation. Each arm is going to be in use for five continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross over change between 3 arms is going to be taked. Then the 2nd week of intervention is performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is going to be repeated again until each classroom will be applied by all three arms of ventilation. A total of 5 weeks is required for the project. Children's biological samples including saliva, urine and skin samples will be collected as well as exhaled NO. A questionnaire on children's perception on air quality will be assessed as well.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date January 22, 2019
Est. primary completion date January 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 13 Years
Eligibility Inclusion Criteria:

- All invited primary school children in Grade 5 in an artibrarily selected school

Exclusion Criteria:

- Current airway symptoms (cough, airway infection, asthma et al.)

- Acute infectious diseases

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fresh air system with filtration
Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms

Locations

Country Name City State
China Fudan University Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exhaled nitric oxide Airway inflammation biomarker within 2 hours of the end of intervention in each week
Primary Oxidative stress biomarkers The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children. within 2 hours of the end of intervention in each week
Primary Sick building symdrom Answering questionnaire on sick biulding symdrom within 2 hours of the end of intervention in each week
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