N/A
N=228
Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT05615870 ↗Enrolled (actual)
228
Serious AEs
12.7%
Results posted
Oct 2025
Primary outcome: Primary: Number of Caregiver-reported Symptom-free Days (SFDs) — 118.01; 112.60 Days — p=0.537
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Winix 5500-2 HEPA filtration units (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- IDeA States Pediatric Clinical Trials Network
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Caregiver-reported Symptom-free Days (SFDs) |
118.01; 112.60 | 0.537 |
| SECONDARY Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints |
0.28; 0.16; 0.68; 0.68; 1.11; 1.48 | 0.205 |
| SECONDARY Total Quality of Life (QOL) Score |
81.34; 82.13 | 0.598 |
| SECONDARY Average Particulate Matter (PM2.5) Levels |
10.70; 15.27; 11.08; 21.45; 10.66; 17.96 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age 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)
Data sourced from ClinicalTrials.gov (NCT05615870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.