跳至主要内容
临床试验/NCT07479420
NCT07479420已完成不适用

Cluster-randomized Controlled Trial Assessing the Impact of Air Cleaning Technologies on Microbial and Physicochemical Markers in Primary School Classrooms

Lidwien Smit1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年12月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Presence and/or concentration of airborne bacteria and viruses in classroom air

研究概览

简要总结

In this study, the investigators tested whether portable air cleaners can improve the air quality in primary school classrooms. Poor air quality can affect children's respiratory health and learning. Classroom air quality is a key concern, as children spend a large part of their day there, often with many students in one room. The investigators studied air quality in 180 classrooms in 29 Dutch primary schools. Within each school, classrooms were grouped in threes based on similar characteristics, such as size, number of students, and ventilation system. Classrooms in each group were randomly assigned to receive either: an air cleaner with a filter that traps particles from the air, an air cleaner that uses an electric charge to remove particles from the air, or no air cleaner (control). All devices were tested for safety in a laboratory beforehand. Measurements were taken in all classrooms before the devices were switched on, to provide a refence point. The air cleaners were then operated for nine weeks. After that, air cleaners were switched off for two weeks while additional measurements continued. To measure the effect of air cleaners, special cloths were placed in classrooms to collect dust and tiny droplets from the air, which were later analyzed in a laboratory for bacteria and viruses. This included viruses that commonly cause respiratory infections, such as flu and respiratory syncytial virus (RSV), and bacteria originating from the human skin, nose, or mouth that can spread through the air. Small sensors also tracked tiny particles in the air (particulate matter). The investigators collected additional information on classroom attendance and parent-reported respiratory symptoms to explore possible links. This study provides real-world evidence on how portable air cleaners can affect classroom air quality and may help guide decisions to improve indoor air environments in schools.

详细描述

The cluster-randomized trial evaluated the effectiveness of portable air cleaners in 180 classrooms across 29 Dutch primary schools. Classrooms were grouped within schools based on similar characteristics and randomly assigned to receive either HEPA-filter air cleaners, ionization/plasma air cleaners, or no air cleaners. The study contained a three-week baseline, followed by three repeated three-week intervention periods and a two-week post-intervention period, resulting in 14 weeks of measurements per school. Air cleaners were pre-tested for safety and operated at a clean air delivery rate (CADR) of approximately 400-500 m³/h during intervention. Airborne dust was collected using electrostatic dust fall collectors (EDCs), a passive air sampling method, and analyzed for respiratory viruses, human-associated bacteria and a general bacterial marker using quantitative polymerase chain reaction (qPCR). In a subset of eleven classrooms, active air sampling was performed alongside EDCs, to validate and quantify passive measurements. Low-cost indoor air sensors continuously monitored particulate matter, CO₂, temperature, relative humidity, and volatile organic compounds (VOCs). Retrospective parent-reported respiratory symptoms and classroom absenteeism data were gathered by surveys. Outcomes will be analyzed using hierarchical mixed-effects models.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Laboratory personnel performing extraction and analysis of microbial air samples were blinded to the classroom intervention allocation. Participants (students and teachers) and investigators were not blinded because the presence of air cleaning devices in classrooms was visible. Analysis of particulate matter (PM) measurements was conducted using sensor data and was not blinded to intervention status.

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Primary schools with at least three comparable classrooms between grade 3-8
  • Regular primary education classrooms
  • Primary schools located within reasonable travel distance of Utrecht, the Netherlands

排除标准

  • Schools for special education
  • Secondary schools
  • Kindergarten classes (grade 1&2; approximately ages 4-6 years)
  • Schools unable or unwilling to provide the required study information

研究组 & 干预措施

HEPA filter air cleaners

Experimental

Classrooms received a portable HEPA filter air cleaner, operated for the duration of the study.

干预措施: HEPA filter air cleaners (Device)

Ionization or plasma air cleaners

Experimental

Classrooms received a portable ionization or plasma air cleaners, operated for the duration of the study.

干预措施: Ionization or plasma air cleaners (Device)

Control

No Intervention

Classrooms received no intervention.

结局指标

主要结局

Presence and/or concentration of airborne bacteria and viruses in classroom air

时间窗: 12 weeks per school

Concentration of particulate matter in classroom air

时间窗: 11 weeks per school

次要结局

  • Respiratory symptoms(Up to 12 months)
  • Student absentee data(12 weeks per school)

研究者

发起方
Lidwien Smit
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lidwien Smit

Professor of One Health and Environmental Epidemiology

Utrecht University

研究点 (1)

Loading locations...

相似试验

Clean Air for Everyone (CLAIRE): an Intervention... | 临床试验