The BREATHE (Bronchiolitis Recovery and the Use of HEPA Filters) study successfully reached its recruitment goal ahead of schedule and has maintained high participant retention with a 94.5% survey completion rate.

This clinical trial, part of the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN), focuses on airway health outcomes of infants hospitalized for bronchiolitis. The study, launched in November 2022 at 17 clinical sites across the country, aimed to recruit 230 children. In December 2023, study teams met their recruitment goal several months ahead of schedule and experienced successful retention over the past six months. ECHO ISPCTN anticipates sharing the primary results of this study in early 2025.

“Recruitment and retention successes are due to the hard work and dedication of each research study coordinator from the 17 sites,” said co-principal investigator Kelly Cowan, MD of the University of Vermont. “A big thank you goes out to these researchers as well as the families who agreed to participate, making a difference in children’s health outcomes.”

The goal of the BREATHE study is to determine whether using high-efficiency particulate air (HEPA) filters in the homes of infants under one year old, who were previously hospitalized for bronchiolitis, reduces symptom-free days from respiratory issues, such as cough or trouble breathing, in the six months after discharge.

Eligible families who consented to participate were randomly placed in an intervention or control group. The intervention group used HEPA units with active filters, and the control group used HEPA units with inactive filters. Caregivers agreed to place the HEPA units where the child slept and in a common space where the child spent a large amount of time. Small air pollution monitors were placed in those rooms to measure how the HEPA filters affected indoor air quality. At the conclusion of the study, all families were welcome to keep the HEPA unit(s) and were sent an individual report of their household’s indoor air quality during the study and a summary of the overall results.

Bronchiolitis, typically caused by a viral infection, is the most common cause of hospitalization in children younger than 2 years old in the U.S. Infants hospitalized for bronchiolitis face a higher risk of persistent respiratory symptoms and developing asthma. To date, no effective treatments have been identified.

Indoor air quality influences respiratory health and may be a promising target for intervention. Homes in rural and low-resourced communities often have greater exposure to sources of air pollution such as wood stoves and wildfires.

“If the intervention is successful, in-home HEPA air filtration would provide a strategy for improving breathing for many infants that will be relatively easy for families to implement,” explained co-principal investigator Erin Semmens, PhD of the University of Montana’s Center for Population Health Research.

Learn more about the BREATHE study.