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

IDeA States Pediatric Clinical Trials Network

Status: Completed

Conditions: Bronchiolitis

Treatments: Other: Winix 5500-2 HEPA filtration units

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT05615870

U24OD024957 (U.S. NIH Grant/Contract)

274137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 1 week to 12 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 2 patient groups

Intervention Group (Active Filter)

Active Comparator group

Description:

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.

Treatment:

Other: Winix 5500-2 HEPA filtration units

Control Group (No Filter)

Sham Comparator group

Description:

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.

Treatment:

Other: Winix 5500-2 HEPA filtration units