Clinical trial NCT04835337: The Health Benefits of Indoor Air Filtration Among Children
Official title: Investigating the Health Benefits of Indoor Air Filtration Among Children: a Randomized Crossover Trial in Jiaozuo, China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protective Effect of Air Purifier on Children's Health
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
First posted: 2021-04-08
Enrollment: 105
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to explore the health benefits of air purifier on the impact of air pollutants on children's health.

Detailed description: From April 2021 to December 2021, researchers conduct a randomized double-blind crossover trial on about 100 healthy children in Jiaozuo City, Henan Province. The children are divided into two groups according to their classes and alternated the use of true or sham purifiers devices, including air purifiers and fresh air ventilation. Air purifiers are installed in the classroom and bedrooms of the children. Fresh air ventilation is installed in the classroom. A total of 4 epidemiological surveys are conducted on the subjects, with an interval of 60 days or more. All participants and research staffs were blinded to the group assignment. In addition, air pollutant exposure monitoring, questionnaire surveys, physical examinations, and biological sample collection are conducted on the research subjects each time. The biological samples are further tested for the concentration levels of related biomarkers such as the respiratory system, cardiovascular system, metabolic system, and nervous system. Furthermore, comprehensive evaluation of children's behavioral ability is also carried out. Ambient PM2.5 and indoor PM2.5 exposure concentrations are monitored in the study.

Eligibility criteria: Inclusion Criteria:

* 10 ≤ 12 years old
* Volunteer to participate in this study

Exclusion Criteria:

* Current and past medical history, including asthma, childhood diabetes, childhood hypertension, behavior-related diseases
* Students who plan to transfer or move within six months
* Unable to cooperate with follow-up

Primary outcomes:
measure: Changes of FEV1
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of FVC
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of FEV1/FVC ratio
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of PEF
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of FEF25-75%
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of MEF75%
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of MEF50%
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of MEF25%
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of FeNO
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of FeCO
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of Blood Pressure
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of heart rate variability
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of PR interval
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of QRS duration
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of QT interval
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of QTc interval
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of RV5
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of SV1
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of RV5+SV1
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of academic performance
timeFrame: Baseline and at the end of each 60 days intervention period
Secondary outcomes:
measure: Changes of CRP
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of 8-OHdG
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of metabolites in exhaled breath condensate
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the role of alertness
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the role of orientation
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the role of conflict
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of Wisconsin Card Sorting Test indicators
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the position total number
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the position number correct
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the position percentage correct
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the color total number
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the color number correct
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the color percentage correct
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the shape total number
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the shape number correct
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of the shape percentage correct
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes of proteins in serum
timeFrame: Baseline and at the end of each 60 days intervention period
measure: Changes in biomarkers identified from other omics
timeFrame: Through study completion, up to 10 years
measure: Changes in other targeted biomarkers of interest
timeFrame: Through study completion, up to 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
Study officials:
affiliation: National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
name: Tiantian Li
role: STUDY_DIRECTOR
References: