Clinical trial NCT05615870: Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
Official title: Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Children<12 months of age hospitalized with bronchiolitis
Lead sponsor: IDeA States Pediatric Clinical Trials Network
Sponsor class: NETWORK
Collaborators: name: University of Vermont Medical Center
name: University of Montana
name: National Institutes of Health (NIH)
First posted: 2022-11-14
Enrollment: 228
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-center, parallel, double-blind, randomized controlled clinical trial
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of caregiver-reported symptom-free days (SFDs)
timeFrame: 24 Weeks
Secondary outcomes:
measure: Number of hospitalizations, emergency department or urgent care visits or other unscheduled medical visits for respiratory complaints
timeFrame: 24 weeks
measure: Total quality of life (QOL) score
timeFrame: 24 weeks
measure: Average Particulate Matter (PM2.5) levels
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Native Tribal Health Consortium
state: Alaska
city: Little Rock
country: United States
facility: Arkansas Children's Hospital - Little Rock (ACHRI)
state: Arkansas
city: Honolulu
country: United States
facility: Kapi'olani Medical Center for Women and Children
state: Hawaii
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University, Department of Pediatrics
state: Louisiana
city: Jackson
country: United States
facility: University of Miss. Medical Center
state: Mississippi
city: Missoula
country: United States
facility: University of Montana
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hospital
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Oklahoma City
country: United States
facility: Children's Hospital OU Medical Center
state: Oklahoma
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Prisma Health-Midlands
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Vermont Medical Center
name: Kelly Cowan, MD
role: STUDY_CHAIR
affiliation: University of Montana
name: Erin Semmens, PhD, MPH
role: STUDY_CHAIR
References: