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临床试验/NCT03788330
NCT03788330已完成不适用

Effects of Fresh Air Filtration System on Indoor Air Quality and Children's Health in Shanghai Schools

Fudan University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2018年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
1
主要终点
Exhaled nitric oxide

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • All invited primary school children in Grade 5 in an artibrarily selected school

排除标准

  • Current airway symptoms (cough, airway infection, asthma et al.)
  • Acute infectious diseases

研究组 & 干预措施

Natural ventilation

No Intervention

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

Fresh air system with filtration

Experimental

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

干预措施: Fresh air system with filtration (Device)

Fresh air system with no filtration

Placebo Comparator

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

干预措施: Fresh air system with filtration (Device)

结局指标

主要结局

Exhaled nitric oxide

时间窗: within 2 hours of the end of intervention in each week

Airway inflammation biomarker

Oxidative stress biomarkers

时间窗: within 2 hours of the end of intervention in each week

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

时间窗: within 2 hours of the end of intervention in each week

Answering questionnaire on sick biulding symdrom

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhuohui Zhao

Investigation director

Fudan University

研究点 (1)

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