School Inner City Air Study

Обзор

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?

Подробное описание

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).

Вмешательства

• Другое Active classroom HEPA cleaner
  Commercially available portable HEPA cleaner
• Другое Sham classroom HEPA cleaner
  Commercially available portable HEPA cleaner with filtration device removed

Первичные конечные точки

• Viral pathogen detected in upper respiratory sample [Срок оценки: 1 year]

Вторичные конечные точки (7)

• Symptomatic respiratory infection (student, teacher) [Срок оценки: 1 year]
• Symptomatic respiratory infection (household member) [Срок оценки: 1 year]
• Viral detection in classroom bioaerosol sample [Срок оценки: 1 year]
• Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report [Срок оценки: 1 year]
• Severity of a cold in adult using the WURSS-24 [Срок оценки: 1 year]
• Number of missed school or work days in last 30 days [Срок оценки: 1 year]
• Number of days requiring inpatient or outpatient care in last 30 days [Срок оценки: 1 year]

Критерии участия

Критерии включения

Children

• 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

Adults

• 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

Критерии исключения

Children

• 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

Adults

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Mass General Brigham — Boston

Идентификаторы

NCT: NCT05953233 · IRB-P00045373 · R21AI178155

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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