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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788330
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Zhuohui Zhao, Fudan University

Study Description
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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
Airway Morbidity Cognitive and Attention Disorders and Disturbances Oxidative Stress Device: Fresh air system with filtration Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : December 7, 2018
Actual Primary Completion Date : January 20, 2019
Actual Study Completion Date : January 22, 2019
Arms and Interventions
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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 Name: 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 Name: mechanical ventilation and filtration system
No Intervention: Natural ventilation
Natural ventilation system was applied in the 3rd classroom as normal.


Outcome Measures
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Primary Outcome Measures :
  1. Exhaled nitric oxide [ Time Frame: within 2 hours of the end of intervention in each week ]
    Airway inflammation biomarker

  2. Oxidative stress biomarkers [ Time Frame: 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 [ Time Frame: within 2 hours of the end of intervention in each week ]
    Answering questionnaire on sick biulding symdrom


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788330


Locations
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China
Fudan University
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
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Study Chair: Zhuohui Zhao, Dr Fudan University
More Information
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Responsible Party: Zhuohui Zhao, Investigation director, Fudan University
ClinicalTrials.gov Identifier: NCT03788330    
Other Study ID Numbers: XFGY001
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuohui Zhao, Fudan University:
exhaled nitric oxide
Sick building syndrome
indoor air
Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders