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

Completed · Not applicable

Conditions studied: Bronchiolitis

In brief

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.

Key facts

Study ID

NCT05615870

Run by

IDeA States Pediatric Clinical Trials Network

People needed

230

Starts

2022-11-07

Expected to finish

2024-07-19

Last updated by the study team

2025-10-02

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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