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

NCT05615870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-10-02

Study results available
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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.

Conditions

  • Bronchiolitis

Interventions

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.

Sponsors & Collaborators

  • University of Vermont Medical Center

    collaborator OTHER

  • University of Montana

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • IDeA States Pediatric Clinical Trials Network

    lead NETWORK

Principal Investigators

  • Kelly Cowan, MD · University of Vermont Medical Center

  • Erin Semmens, PhD, MPH · University of Montana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2024-07-05
Completion
2024-07-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05615870 on ClinicalTrials.gov