The BREATHE Study: A Randomized Controlled Trial of Bronchiolitis Recovery and Use of HEPA Filters

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Abstract RATIONALE: Viral bronchiolitis is the most common reason for infant hospitalization in the United States (US). Such infants are at increased risk for recurrent respiratory symptoms, wheeze, and persistent childhood asthma. Indoor air quality may be a modifiable environmental risk factor. One common air pollutant strongly linked to health effects is particulate matter <2.5 micrometers in diameter (PM2.5). PM2.5 can be decreased with high efficiency particulate air (HEPA) filtration units. The BREATHE study is a multi-center, parallel, double-blind, randomized controlled trial evaluating whether in-home use of HEPA filtration units for 24 weeks reduced respiratory symptom burden (measured by symptom-free days, SFDs) after bronchiolitis hospitalization compared to placebo (identical units without HEPA filter). METHODS: Infants <12 months of age from non-smoking households hospitalized for the first time with bronchiolitis were enrolled from 17 hospitals across the US between 11/2022 and 12/2023. Infants (n=228) were randomized 1:1 to receive either two functioning HEPA units or two placebo HEPA units. One unit was placed in the infant sleeping space and one in the common room. SFDs (24 hours without cough, wheeze, or trouble breathing) were captured weekly by caregiver report over the 24-week (168 days) intervention period. The total SFDs of 24 weeks between two groups were compared using generalized linear mixed model with negative binomial distribution with site as a random effect based on complete case intent-to-treat analysis. Average SFDs, standard deviations, and respective 95% CIs were calculated for each intervention group. RESULTS: There were 219 infants in the complete case intent-to-treat analysis. The weekly survey completion was 94%. Mean SFDs in the HEPA group were 118 (SD 42.7) vs 112.6 (SD 46.3) in the placebo group. Preliminary results showed a non-statistically significant difference of 5.4 (95% CI: 5.0, 5.8; p=0.371) more SFDs in the HEPA group compared to placebo group. CONCLUSIONS: In the intention to treat analysis, there was no statistically significant difference in symptom-free days over 24 weeks between the HEPA filtration unit intervention and placebo groups for infants recovering from hospitalized bronchiolitis. Subgroup analyses will be performed to learn whether data suggests potential clinically meaningful difference in particular subgroups (for example, by compliance with the intervention and by PM2.5 levels in the home). Future planned analyses include a comparison of unscheduled healthcare visits, quality of life, and average PM2.5 levels in the home over the duration of the study.

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