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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Bronchiolitis | Study protocol

Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial

Authors: Kelly Cowan, Erin O. Semmens, Jeannette Y. Lee, Ethan S. Walker, Paul G. Smith, Linda Fu, Rosalyn Singleton, Sara McClure Cox, Jennifer Faiella, Laurie Chassereau, Lora Lawrence, Jun Ying, Jaime Baldner, Maryam Garza, Robert Annett, Sheva K. Chervinskiy, Jessica Snowden

Published in: Trials | Issue 1/2024

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Abstract

Background

Acute viral bronchiolitis is the most common reason for hospitalization of infants in the USA. Infants hospitalized for bronchiolitis are at high risk for recurrent respiratory symptoms and wheeze in the subsequent year, and longer-term adverse respiratory outcomes such as persistent childhood asthma. There are no effective secondary prevention strategies. Multiple factors, including air pollutant exposure, contribute to risk of adverse respiratory outcomes in these infants. Improvement in indoor air quality following hospitalization for bronchiolitis may be a prevention opportunity to reduce symptom burden. Use of stand-alone high efficiency particulate air (HEPA) filtration units is a simple method to reduce particulate matter ≤ 2.5 µm in diameter (PM2.5), a common component of household air pollution that is strongly linked to health effects.

Methods

BREATHE is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred twenty-eight children < 12 months of age hospitalized for the first time with bronchiolitis will participate. Children will be randomized 1:1 to receive a 24-week home intervention with filtration units containing HEPA and carbon filters (in the child’s sleep space and a common room) or to a control group with units that do not contain HEPA and carbon filters. The primary objective is to determine if use of HEPA filtration units reduces respiratory symptom burden for 24 weeks compared to use of control units. Secondary objectives are to assess the efficacy of the HEPA intervention relative to control on (1) number of unscheduled healthcare visits for respiratory complaints, (2) child quality of life, and (3) average PM2.5 levels in the home.

Discussion

We propose to test the use of HEPA filtration to improve indoor air quality as a strategy to reduce post-bronchiolitis respiratory symptom burden in at-risk infants with severe bronchiolitis. If the intervention proves successful, this trial will support use of HEPA filtration for children with bronchiolitis to reduce respiratory symptom burden following hospitalization.

Trial registration

NCT05615870. Registered on November 14, 2022.
Appendix
Available only for authorised users
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Metadata
Title
Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial
Authors
Kelly Cowan
Erin O. Semmens
Jeannette Y. Lee
Ethan S. Walker
Paul G. Smith
Linda Fu
Rosalyn Singleton
Sara McClure Cox
Jennifer Faiella
Laurie Chassereau
Lora Lawrence
Jun Ying
Jaime Baldner
Maryam Garza
Robert Annett
Sheva K. Chervinskiy
Jessica Snowden
Publication date
01-12-2024
Publisher
BioMed Central
Keyword
Bronchiolitis
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08012-0

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