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

Sponsor

IDeA States Pediatric Clinical Trials Network (Other)

Overall Status

Recruiting

CT.gov ID

NCT05615870

Collaborator

University of Vermont Medical Center (Other), University of Montana (Other), National Institutes of Health (NIH) (NIH)

218

Enrollment

Locations

Arms

23.8

Anticipated Duration (Months)

12.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis	Other: Winix 5500-2 HEPA filtration units	N/A

Detailed Description

This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred eighteen 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

218 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a multi-center, parallel, double-blind, randomized controlled clinical trialThis is a multi-center, parallel, double-blind, randomized controlled clinical trial

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Families will be masked as to whether their Winix units are equipped with or without HEPA/carbon filters. Study coordinators, investigators, and other team members who interact with participants' parent(s)/guardian(s) to obtain surveys, troubleshoot equipment setup and operation, or have other interactions will remain masked through the duration of the study for individual participants. This includes masking as to which intervention the participants receive and household air quality measurements, including the baseline measurements (separate personnel will need to be on the receiving end for air quality measurement data). This will require more than one study coordinator or additional staff/technician on the study team.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 7, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Group (Active Filter) The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.	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.
Sham Comparator: Control Group (No Filter) The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.	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.

Arm

Intervention/Treatment

Active Comparator: Intervention Group (Active Filter)

The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.

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.

Sham Comparator: Control Group (No Filter)

The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.

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.

Outcome Measures

Primary Outcome Measures

Number of caregiver-reported symptom-free days (SFDs) [24 Weeks]
An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing

Secondary Outcome Measures

Number of hospitalizations, emergency department or urgent care visits or other unscheduled medical visits for respiratory complaints [24 weeks]
Total quality of life (QOL) score [24 weeks]
QOL score is measured by the PedsQLTM Pediatric Quality of Life Inventory Infants Scales questionnaire
Average Particulate Matter (PM2.5) levels [24 weeks]
PM2.5 levels are measured by in-home monitors and scaled to unit of micrograms per cubic meter per week

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Week to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Native Tribal Health Consortium	Anchorage	Alaska	United States	99508
2	Arkansas Children's Hospital - Little Rock (ACHRI)	Little Rock	Arkansas	United States	72202
3	Kapi'olani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
4	Kansas University Medical Center	Kansas City	Kansas	United States	66160
5	University of Louisville	Louisville	Kentucky	United States	40292
6	Tulane University, Department of Pediatrics	New Orleans	Louisiana	United States	70112
7	University of Miss. Medical Center	Jackson	Mississippi	United States	39216
8	University of Montana	Missoula	Montana	United States	59812
9	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
10	Dartmouth Hospital	Lebanon	New Hampshire	United States	03756
11	University of New Mexico Health Sciences Center	Albuquerque	New Mexico	United States	87131
12	Children's Hospital OU Medical Center	Oklahoma City	Oklahoma	United States	73104
13	Rhode Island Hospital	Providence	Rhode Island	United States	02903
14	Prisma Health-Midlands	Columbia	South Carolina	United States	29203
15	Avera Research Institute	Sioux Falls	South Dakota	United States	57108
16	University of Vermont Medical Center	Burlington	Vermont	United States	05401
17	West Virginia University	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

IDeA States Pediatric Clinical Trials Network
University of Vermont Medical Center
University of Montana
National Institutes of Health (NIH)

Investigators

Study Chair: Kelly Cowan, M.D., University of Vermont Medical Center
Study Chair: Erin Semmens, PhD, MPH, University of Montana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IDeA States Pediatric Clinical Trials Network

ClinicalTrials.gov Identifier:

NCT05615870

Other Study ID Numbers:

274137
U24OD024957

First Posted:

Nov 14, 2022

Last Update Posted:

Jan 6, 2023

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IDeA States Pediatric Clinical Trials Network

Children<12 months of age hospitalized with bronchiolitis

Additional relevant MeSH terms:

Bronchiolitis

Study Results

No Results Posted as of Jan 6, 2023