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

Bronchiolitis Clinical Trial

— BREATHE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05615870
• Other study ID #: 274137
• Secondary ID: U24OD024957
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: IDeA States Pediatric Clinical Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 228
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Week to 12 Months

Eligibility

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)

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Alaska Native Tribal Health Consortium	Anchorage	Alaska
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Prisma Health-Midlands	Columbia	South Carolina
United States	Kapi'olani Medical Center for Women and Children	Honolulu	Hawaii
United States	University of Miss. Medical Center	Jackson	Mississippi
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Dartmouth Hospital	Lebanon	New Hampshire
United States	Arkansas Children's Hospital - Little Rock (ACHRI)	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	University of Montana	Missoula	Montana
United States	West Virginia University	Morgantown	West Virginia
United States	Tulane University, Department of Pediatrics	New Orleans	Louisiana
United States	Children's Hospital OU Medical Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Avera Research Institute	Sioux Falls	South Dakota

Sponsors (4)

Lead Sponsor	Collaborator
IDeA States Pediatric Clinical Trials Network	National Institutes of Health (NIH), University of Montana, University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of hospitalizations, emergency department or urgent care visits or other unscheduled medical visits for respiratory complaints		24 weeks
Secondary	Total quality of life (QOL) score	QOL score is measured by the PedsQLTM Pediatric Quality of Life Inventory Infants Scales questionnaire	24 weeks
Secondary	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