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

NCT ID: NCT03788330

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2019-01-22

Brief Summary

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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

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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.

Conditions

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Airway Morbidity Cognitive and Attention Disorders and Disturbances Oxidative Stress

Keywords

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exhaled nitric oxide Sick building syndrome indoor air

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fresh air system with filtration

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

Group Type EXPERIMENTAL

Fresh air system with filtration

Intervention Type DEVICE

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

Fresh air system with no filtration

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

Group Type PLACEBO_COMPARATOR

Fresh air system with filtration

Intervention Type DEVICE

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

Natural ventilation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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mechanical ventilation and filtration system

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhuohui Zhao

Investigation director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhuohui Zhao, Dr

Role: STUDY_CHAIR

Fudan University

Locations

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Fudan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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XFGY001

Identifier Type: -

Identifier Source: org_study_id