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

Bronchiolitis Clinical Trial

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

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bronchiolitis

• NCT number: NCT05615870
• Study type: Interventional
• Source: IDeA States Pediatric Clinical Trials Network
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2022
• Completion date: June 2024