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

NCT05615870 | Completed Results DMC

• 2 other identifiers: 274137U24OD024957
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Bronchiolitis

Keywords

Children<12 months of age hospitalized with bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints

  24 weeks

• Total Quality of Life (QOL) Score

  24 weeks

• Average Particulate Matter (PM2.5) Levels

  24 weeks

Study Arms (2)

Intervention Group (Active Filter)

ACTIVE COMPARATOR

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

Control Group (No Filter)

SHAM COMPARATOR

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

Interventions

Winix 5500-2 HEPA filtration units OTHER

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); Intervention Group (Active Filter)

Eligibility Criteria

• Age: 1 Week - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IDeA States Pediatric Clinical Trials Network: lead
• University of Vermont Medical Center: collaborator
• University of Montana: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (17)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99508, United States

Location

Arkansas Children's Hospital - Little Rock (ACHRI)

Little Rock, Arkansas, 72202, United States

Location

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Tulane University, Department of Pediatrics

New Orleans, Louisiana, 70112, United States

Location

University of Miss. Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Montana

Missoula, Montana, 59812, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth Hospital

Lebanon, New Hampshire, 03756, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Children's Hospital OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Prisma Health-Midlands

Columbia, South Carolina, 29203, United States

Location

Avera Research Institute

Sioux Falls, South Dakota, 57108, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 38504367 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Results Point of Contact

• Title: Jing Jin
• Organization: University of Arkansas for Medical Sciences

JJin@UAMS.edu

501-214-2236

Study Officials

• Kelly Cowan, MD

  University of Vermont Medical Center

  STUDY CHAIR

• Erin Semmens, PhD, MPH

  University of Montana

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Families will be masked as to whether their Winix units are equipped with or without HEPA/carbon filters. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a multi-center, parallel, double-blind, randomized controlled clinical trial

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: November 14, 2022
• Study Start: November 7, 2022
• Primary Completion: July 5, 2024
• Study Completion: July 19, 2024
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• 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.
• Access Criteria: TBA

Locations

US (17)