School Inner City Air Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Viral pathogen detected in upper respiratory sample
研究概览
简要总结
The goal of this randomized clinical trial is to test the efficacy of high efficiency particulate air (HEPA) cleaners in reducing respiratory viral exposure and infections in elementary school classrooms. Classrooms will be randomized to active vs. sham HEPA cleaners. The main questions it aims to answer are:
- Do classroom HEPA cleaners reduce exposure to viruses?
- Do classroom HEPA cleaners reduce student and teacher infections?
- Do classroom HEPA cleaners reduce infections in family members?
详细描述
Classrooms from participating schools will be randomized to active vs. sham HEPA cleaners. From enrolled classrooms, we will enroll students, teachers, and members of the household. We will collect the following:
- longitudinal classroom air samples
- longitudinal upper respiratory samples
- longitudinal symptom surveys using the Wisconsin Upper Respiratory Symptom Survey (WURSS) Viral testing on collected air and respiratory samples will be performed using digital polymerase chain reaction (dPCR).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Sham cleaners are constructed by removing the filters from air cleaners and adding a sound generator rendering them indistinguishable from active HEPA cleaners.
入排标准
- 年龄范围
- 6 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Grades K-5 (age 6-12 years)
- •Attend one of the schools that the study team has permission to obtain classroom/school environmental samples
- •Have no plans to move schools within the upcoming 12 months
- •Subject and/or parent guardian must be able to understand and provide informed consent and also willing to participate in the study
- •Adult (age 21 or older) parent, caretaker, or household member of child participating in this study, or teacher in classroom participating in study
- •Able to understand and provide informed consent
排除标准
- •Contraindication to or inability to participate in home self-collection of nasal swab samples
- •Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
- •Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
- •Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures
- •Contraindication to or inability to participate in home self-collection of nasal swab samples
- •Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
- •Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
- •Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures
结局指标
主要结局
Viral pathogen detected in upper respiratory sample
时间窗: 1 year
Presence/absence of a respiratory virus in upper respiratory sample
次要结局
- Severity of a cold in adult using the WURSS-24(1 year)
- Number of missed school or work days in last 30 days(1 year)
- Symptomatic respiratory infection (household member)(1 year)
- Viral detection in classroom bioaerosol sample(1 year)
- Number of days requiring inpatient or outpatient care in last 30 days(1 year)
- Symptomatic respiratory infection (student, teacher)(1 year)
- Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report(1 year)
研究者
Peggy S Lai
Associate Professor
Massachusetts General Hospital