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Recruiting
NCT05615870
Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
Conditions: Bronchiolitis
Sex: All
Ages: 1 Week – 12 Months
Healthy volunteers: 1
Phase: NA
Enrollment: 218
Sponsor: IDeA States Pediatric Clinical Trials Network
Location: United States
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 <12 months at hospital admissionFirst-time hospitalization for bronchiolitisOne 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 activitiesElectricity 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 guardianExclusion 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 homeHousehold member who smokes (any type), vapes, or uses e-cigarettesIntention to move in the next 6 monthsEnrolled or plans to enroll in an interventional clinical trial for treatment of acute bronchiolitis or sequelae of bronchiolitis, unless permission given by the PIAnother child in the household is enrolled in this study (one child per household can enroll)
Source: ClinicalTrials.gov (NCT05615870). StuddyBuddy aggregates publicly available trial information.