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Short-term Health Benefits of Using Fresh Air Filtration System in Classroom

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT03788330
Collaborator
(none)
94
Enrollment
1
Location
3
Arms
1.5
Actual Duration (Months)
62.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fresh air system with filtration
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Effects of Fresh Air Filtration System on Indoor Air Quality and Children's Health in Shanghai Schools
Actual Study Start Date :
Dec 7, 2018
Actual Primary Completion Date :
Jan 20, 2019
Actual Study Completion Date :
Jan 22, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fresh air system with filtration

A fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom.

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
Other Names:
  • mechanical ventilation and filtration system

    		•
    Placebo Comparator: Fresh air system with no filtration

    A fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom.

    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
    Other Names:
  • mechanical ventilation and filtration system

    		•
    No Intervention: Natural ventilation

    Natural ventilation system was applied in the 3rd classroom as normal.

    Outcome Measures

    Primary Outcome Measures

    1. Exhaled nitric oxide [within 2 hours of the end of intervention in each week]

      Airway inflammation biomarker

    2. Oxidative stress biomarkers [within 2 hours of the end of intervention in each week]

      The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children.

    3. Sick building symdrom [within 2 hours of the end of intervention in each week]

      Answering questionnaire on sick biulding symdrom

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Study Chair: Zhuohui Zhao, Dr, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhuohui Zhao, Investigation director, Fudan University
    ClinicalTrials.gov Identifier:
    NCT03788330
    Other Study ID Numbers:
    • XFGY001
    First Posted:
    Dec 27, 2018
    Last Update Posted:
    Mar 29, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhuohui Zhao, Investigation director, Fudan University
    exhaled nitric oxide
    Sick building syndrome
    indoor air
    Additional relevant MeSH terms:
    Cognition Disorders

    Study Results

    No Results Posted as of Mar 29, 2019