Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters (BREATHE)
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| ClinicalTrials.gov Identifier: NCT05615870 |
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Recruitment Status :
Active, not recruiting
First Posted : November 14, 2022
Last Update Posted : February 20, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchiolitis | Other: Winix 5500-2 HEPA filtration units | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 228 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a multi-center, parallel, double-blind, randomized controlled clinical trial |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | 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. |
| Primary Purpose: | Prevention |
| Official Title: | Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters |
| Actual Study Start Date : | November 7, 2022 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | June 2024 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
- Number of caregiver-reported symptom-free days (SFDs) [ Time Frame: 24 Weeks ]An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing
- Number of hospitalizations, emergency department or urgent care visits or other unscheduled medical visits for respiratory complaints [ Time Frame: 24 weeks ]
- Total quality of life (QOL) score [ Time Frame: 24 weeks ]QOL score is measured by the PedsQLTM Pediatric Quality of Life Inventory Infants Scales questionnaire
- Average Particulate Matter (PM2.5) levels [ Time Frame: 24 weeks ]PM2.5 levels are measured by in-home monitors and scaled to unit of micrograms per cubic meter per week
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Week to 12 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05615870
Show 17 study locations
| Study Chair: | Kelly Cowan, M.D. | University of Vermont Medical Center | |
| Study Chair: | Erin Semmens, PhD, MPH | University of Montana |
| Responsible Party: | IDeA States Pediatric Clinical Trials Network |
| ClinicalTrials.gov Identifier: | NCT05615870 |
| Other Study ID Numbers: |
274137 U24OD024957 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 14, 2022 Key Record Dates |
| Last Update Posted: | February 20, 2024 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 |
| Supporting Materials: |
Statistical Analysis Plan (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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Children<12 months of age hospitalized with bronchiolitis |
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Bronchiolitis Bronchitis Respiratory Tract Infections Infections |
Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |