Back to resultsShort-term Health Benefits of Using Fresh Air Filtration System in Classroom
Primary Purpose
Airway Morbidity, Cognitive and Attention Disorders and Disturbances, Oxidative Stress
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fresh air system with filtration
Sponsored by
About this trial
This is an interventional prevention trial for Airway Morbidity focused on measuring exhaled nitric oxide, Sick building syndrome, indoor air
Eligibility 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
Sites / Locations
- Fudan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Fresh air system with filtration
Fresh air system with no filtration
Natural ventilation
Arm Description
A fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom.
A fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom.
Natural ventilation system was applied in the 3rd classroom as normal.
Outcomes
Primary Outcome Measures
Exhaled nitric oxide
Airway inflammation biomarker
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.
Sick building symdrom
Answering questionnaire on sick biulding symdrom
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03788330
Brief Title
Short-term Health Benefits of Using Fresh Air Filtration System in Classroom
Official Title
Effects of Fresh Air Filtration System on Indoor Air Quality and Children's Health in Shanghai Schools
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Morbidity, Cognitive and Attention Disorders and Disturbances, Oxidative Stress
Keywords
exhaled nitric oxide, Sick building syndrome, indoor air
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fresh air system with filtration
Arm Type
Experimental
Arm Description
A fresh air ventilation system combined with PM2.5 filtration is applied in one primary school classroom.
Arm Title
Fresh air system with no filtration
Arm Type
Placebo Comparator
Arm Description
A fresh air ventilation system with no PM2.5 filtration is applied in a parallel classroom.
Arm Title
Natural ventilation
Arm Type
No Intervention
Arm Description
Natural ventilation system was applied in the 3rd classroom as normal.
Intervention Type
Device
Intervention Name(s)
Fresh air system with filtration
Other Intervention Name(s)
mechanical ventilation and filtration system
Intervention Description
Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms
Primary Outcome Measure Information:
Title
Exhaled nitric oxide
Description
Airway inflammation biomarker
Time Frame
within 2 hours of the end of intervention in each week
Title
Oxidative stress biomarkers
Description
The level of lysozyme, cortisone and SIgA will be assessed in saliva and other oxidative biomarkers in the urine samples in children.
Time Frame
within 2 hours of the end of intervention in each week
Title
Sick building symdrom
Description
Answering questionnaire on sick biulding symdrom
Time Frame
within 2 hours of the end of intervention in each week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuohui Zhao, Dr
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short-term Health Benefits of Using Fresh Air Filtration System in Classroom
We'll reach out to this number within 24 hrs