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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bronchiolitis

Intervention / Treatment
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* Other: Winix 5500-2 HEPA filtration units


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multi-center, parallel, double-blind, randomized controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group (Active Filter)<br>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<br>* 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.<br>|
| Sham Comparator: Control Group (No Filter)<br>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<br>* 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.<br>|

What is the study measuring?
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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 |  | 24 weeks | 
| Total quality of life (QOL) score | QOL score is measured by the PedsQLTM Pediatric Quality of Life Inventory Infants Scales questionnaire | 24 weeks | 
| Average Particulate Matter (PM2.5) levels | PM2.5 levels are measured by in-home monitors and scaled to unit of micrograms per cubic meter per week | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children<12 months of age hospitalized with bronchiolitis