Clinical trial NCT05016271: Health Benefits of Air Purifiers in Primary School Students
Official title: Health Benefits of Air Purifiers in Primary School Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiopulmonary Function
Child
Keywords: Air pollution
Particulate matter
Air Purifiers
Cardiopulmonary system
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 110
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to explore changes in cardiopulmonary function and other health indicators in primary school students with the intervention of air purifiers on a randomized controlled trial.

Detailed description: The investigators will conduct a randomized controlled trial among 110 healthy children in Jiaozuo city, Henan, China. The eligible children will be divided into two groups according to their classes and randomly receive interventions of either true or sham air purifiers. The air purifiers devices in classroom \[air purifiers and fresh air ventilation systems\] will operate during the school time and the devices in bedrooms (air purifiers) operate during the home time in the intervention period. All the participants and investigators will be blinded to the group assignment. Epidemiological questionnaires (i.e., basic characteristics, eating habits, daily schedule, etc.) will be conducted and health indicators (i.e., blood pressure, pulmonary function indicators, fractional exhaled nitric oxide, and fractional exhaled carbon monoxide) and biological specimens (i.e., morning urine, venous blood, exhaled breath condensate, and feces) will be evaluated and collected at baseline and after the completion of intervention period (4 months anticipated).

Eligibility criteria: Inclusion Criteria:

* Age of between 8 and 12 years old
* Males and female of ethnic Han
* Subjects who have no plans to change classroom during the intervention period
* Subjects who staying in Jiaozuo city during the intervention period

Exclusion Criteria:

* Subjects with asthma, childhood diabetes, childhood hypertension, and behavioral disorders
* Subjects who plan to transfer or move offsite within six months
* Subjects who decorated or plan to decorate home within six months
* Subjects with smokers in the household

Primary outcomes:
measure: Changes of heart rate variability
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of forced expiratory volume in 1 s (FEV1)
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of forced vital capacity (FVC)
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of peak expiratory flow (PEF)
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of fractional exhaled nitric oxide (FeNO) levels
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of fractional exhaled carbon monoxide (FeCO) levels
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of blood pressure
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
Secondary outcomes:
measure: Changes of C-reactive protein (CRP)
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of 8-hydroxydeoxyguanosine (8-OHdG)
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Changes of persistent response (PR)
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
measure: Differences in metabolite levels detected in metabolomics between groups of intervention and control.
timeFrame: Baseline and after the completion of intervention period (4 months anticipated)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
References: