Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters (BREATHE)

This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Children <12 months of age hospitalized with bronchiolitis are 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) to improve indoor air quality (IAQ) or to a control group with filtration units without HEPA and carbon filters. The HEPA intervention units and control units will be used for 24 weeks after pre-intervention IAQ measurements. Children are followed for respiratory outcomes over the pre-intervention and intervention periods.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Winix 5500-2 HEPA filtration units

Detailed Description

This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred twenty-eight children <12 months old with their first hospitalization for bronchiolitis will be randomized 1:1 (stratified by site) to receive 24 weeks of home intervention with active HEPA filtration units to improve IAQ or to a control group without a HEPA or carbon filter inside identical-appearing units. Children will be followed for respiratory symptoms during a pre-intervention period of up to two weeks following randomization and during an intervention period of 24 weeks.

This study is designed to reduce barriers to participation for rural participants in that there will be no required study visits to a distant study site, and all study activities and data collection will be conducted remotely. Participants will be identified in hospitals in ISPCTN states, maximizing the chances that rural and medically underserved populations are represented. It is common for rural children with bronchiolitis to be transferred to tertiary care centers in urban/suburban locales, so inclusion of urban hospitals will allow for recruitment of this population.1 It is important for rural children to be represented in a bronchiolitis study in order to increase generalizability. Rural and underserved children have a higher risk of decreased access to medical care for symptoms and illness episodes, and a higher burden of asthma.83,84 These families may have air pollutant exposure profiles distinct from those residing in urban areas. For example, they might experience less exposure to traffic-related pollutants but may have more wood stove use or exposure to agricultural pollutants or wildfires. With its diversity of sites, the ECHO ISPCTN is well-positioned to enroll rural children that might otherwise be excluded.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Native Tribal Health Consortium
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital - Little Rock (ACHRI)
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Kapi'olani Medical Center for Women and Children
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40292
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University, Department of Pediatrics
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Miss. Medical Center
  • Montana
    • Missoula, Montana, United States, 59812
      • University of Montana
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Health Sciences Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Children's Hospital OU Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health-Midlands
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Avera Research Institute
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age <12 months at hospital admission
• First-time hospitalization for bronchiolitis
• One primary residence (>5 days per week)
• Parent, legal guardian or other legally authorized representative consents to allow their child to participate and agrees to participate in all study activities
• Electricity in the home (required to power the study equipment)
• Wireless internet access or cellular service access in the home*
• English or Spanish-speaking parent or guardian

Exclusion Criteria:

• Chronic airway or respiratory conditions requiring home oxygen, mechanical ventilation, or tracheostomy dependence; known immunodeficiency, hemodynamically significant cardiac conditions including those requiring medication or oxygen; cystic fibrosis; neuromuscular disease; eligible for palivizumab (per AAP guidelines87)
• Use of stand-alone home HEPA filtration other than study-related HEPA units in the home
• Household member who smokes (any type), vapes, or uses e-cigarettes
• Intention to move in the next 6 months
• Enrolled or plans to enroll in an interventional clinical trial for treatment of acute bronchiolitis or sequelae of bronchiolitis, unless permission given by the PI
• Another child in the household is enrolled in this study (one child per household can enroll)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group (Active Filter); The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.	Other: Winix 5500-2 HEPA filtration units; To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
Sham Comparator: Control Group (No Filter); The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.	Other: Winix 5500-2 HEPA filtration units; To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Caregiver-reported Symptom-free Days (SFDs)	An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints	Caregiver reported number of hospitalizations, emergency department or urgent care visits, other unscheduled medical visits, and the sum of total counts of all metrics for respiratory complaints	24 weeks
Total Quality of Life (QOL) Score	QOL score is measured by the Pediatric Quality of Life Inventory TM (PedsQLTM) Infants Scales questionnaire. The scores are reverse-scored and linearly transformed to a 0-100 scale. Higher scores mean a better outcome.	24 weeks
Average Particulate Matter (PM2.5) Levels	PM2.5 levels (Particulate Matter ≤ 2.5 micrometers in diameter) are measured by in-home monitors and scaled to unit of micrograms per cubic meter per week. Higher levels mean a worse outcome.	24 weeks

Collaborators and Investigators

• Sponsor: IDeA States Pediatric Clinical Trials Network
• Collaborators: National Institutes of Health (NIH); University of Vermont Medical Center; University of Montana
• Investigators: Study Chair: Erin Semmens, PhD, MPH, University of Montana; Study Chair: Kelly Cowan, MD, University of Vermont Medical Center

Publications and helpful links

General Publications

• Cowan K, Semmens EO, Lee JY, Walker ES, Smith PG, Fu L, Singleton R, Cox SM, Faiella J, Chassereau L, Lawrence L, Ying J, Baldner J, Garza M, Annett R, Chervinskiy SK, Snowden J. 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. Trials. 2024 Mar 20;25(1):197. doi: 10.1186/s13063-024-08012-0.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): July 5, 2024
• Study Completion (Actual): July 19, 2024

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Children<12 months of age hospitalized with bronchiolitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 274137; U24OD024957 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team will place participant's de-identified data and other limited information, such as race and ethnic group, into one or more centralized database(s). The study team will share this data in compliance with the ISPCTN and NIH data sharing policies

IPD Sharing Time Frame

NIH Public Access Policy ensures public access to the published results of NIH-funded research. Scientists are required to submit final peer-reviewed journal manuscripts from NIH funds to the digital archive PubMed Central upon publication acceptance.

ECHO ISPCTN Publications and Presentations Policy, ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. The ECHO ISPCTN Steering Committee has approved and ratified the Publications and Presentations Policy, which includes representatives from all site awardees, as well as representatives from NIH and the DCOC NIH Data Sharing Policy, the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission Rule. Trial results will be submitted to ClinicalTrials.gov. Additional plans are to publish results in peer reviewed journals. Researchers may request trial data by contacting Jeannette Lee, PhD, at the DCOC.

• IPD Sharing Access Criteria: TBA
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No