Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
NCT ID: NCT05615870
Last Updated: 2025-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2022-11-07
2024-07-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study coordinators, investigators, and other team members who interact with participants' parent(s)/guardian(s) to obtain surveys, troubleshoot equipment setup and operation, or have other interactions will remain masked through the duration of the study for individual participants. This includes masking as to which intervention the participants receive and household air quality measurements, including the baseline measurements (separate personnel will need to be on the receiving end for air quality measurement data). This will require more than one study coordinator or additional staff/technician on the study team.
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
1 Week
12 Months
ALL
Yes
Sponsors
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University of Vermont Medical Center
OTHER
University of Montana
OTHER
National Institutes of Health (NIH)
NIH
IDeA States Pediatric Clinical Trials Network
NETWORK
Responsible Party
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Principal Investigators
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Kelly Cowan, MD
Role: STUDY_CHAIR
University of Vermont Medical Center
Erin Semmens, PhD, MPH
Role: STUDY_CHAIR
University of Montana
Locations
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Alaska Native Tribal Health Consortium
Anchorage, Alaska, United States
Arkansas Children's Hospital - Little Rock (ACHRI)
Little Rock, Arkansas, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States
Kansas University Medical Center
Kansas City, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University, Department of Pediatrics
New Orleans, Louisiana, United States
University of Miss. Medical Center
Jackson, Mississippi, United States
University of Montana
Missoula, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hospital
Lebanon, New Hampshire, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Children's Hospital OU Medical Center
Oklahoma City, Oklahoma, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Prisma Health-Midlands
Columbia, South Carolina, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
University of Vermont Medical Center
Burlington, Vermont, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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274137
Identifier Type: -
Identifier Source: org_study_id
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