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HEPA Filter

HEPA Filters for Bronchiolitis (BREATHE Trial)

N/A
Waitlist Available
Research Sponsored by IDeA States Pediatric Clinical Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
First-time hospitalization for bronchiolitis
Age <12 months at hospital admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

BREATHE Trial Summary

This trial will compare HEPA and carbon filters to improve indoor air quality in hospitalized children <12 months with bronchiolitis.

Who is the study for?
This trial is for babies under 12 months old hospitalized with their first case of bronchiolitis. They must live in a home with electricity, internet or cellular service, and speak English or Spanish. Babies can't join if they have chronic respiratory conditions, are on certain medications, plan to move soon, live with smokers/vapers, or if another child in the home is already enrolled.Check my eligibility
What is being tested?
The study tests whether using HEPA filtration units at home for 24 weeks can improve air quality and help children recover from bronchiolitis. Half of the participants will get real HEPA filters while the other half will get placebo filters without active filtering capabilities.See study design
What are the potential side effects?
Since this trial involves using air filtration units rather than medication, there are no direct side effects expected from the intervention itself.

BREATHE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
This is my first hospital visit for bronchiolitis.
Select...
I was under 1 year old when admitted to the hospital.

BREATHE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of caregiver-reported symptom-free days (SFDs)
Secondary outcome measures
Average Particulate Matter (PM2.5) levels
Number of hospitalizations, emergency department or urgent care visits or other unscheduled medical visits for respiratory complaints
Total quality of life (QOL) score

BREATHE Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention Group (Active Filter)Active Control1 Intervention
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.
Group II: Control Group (No Filter)Placebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

IDeA States Pediatric Clinical Trials NetworkLead Sponsor
4 Previous Clinical Trials
943 Total Patients Enrolled
1 Trials studying Bronchiolitis
University of Vermont Medical CenterOTHER
41 Previous Clinical Trials
25,597 Total Patients Enrolled
University of MontanaOTHER
23 Previous Clinical Trials
3,326 Total Patients Enrolled

Media Library

Bronchiolitis Clinical Trial 2023: Winix 5500-2 HEPA filtration units Highlights & Side Effects. Trial Name: NCT05615870 — N/A
Bronchiolitis Patient Testimony for trial: Trial Name: NCT05615870 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment encompass geriatric participants?

"According to the trial's eligibility guidelines, the minimum age for inclusion is 1 Week and the maximum age limit is 12 Months."

Answered by AI

Are any North American healthcare centers partaking in this clinical assessment?

"This study is recruiting from 17 locations, including Kapi'olani Medical Center for Women and Children in Honolulu, University of Miss. Medical Centre in Jackson, Rhode island Hospital in Providence, and 14 additional sites."

Answered by AI

Is there currently an opportunity to join this medical experiment?

"The clinical trial is open for enrolment, as evidenced by its listing on clinicaltrials.gov; the study was initially posted on November 1st 2022 and edited most recently at the end of that month."

Answered by AI

Is participation in this research endeavor still open?

"Eligible participants in this study must have bronchiolitis and be within the specified age range of one week to 12 months. A total of 218 individuals are needed for recruitment."

Answered by AI

What is the aggregate figure of enrollees in this medical experiment?

"This clinical trial necessitates 218 patients who comply with the criteria of inclusion. Patients can take part at a number of locations such as Kapi'olani Medical Center for Women and Children in Honolulu, Hawaii or University of Miss. Medical Centre in Jackson, Mississippi."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What site did they apply to?
Tulane University, Department of Pediatrics
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Antibiotic that you inhale could not do it.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters
2022. "Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05615870.
All > Bronchiolitis > Honolulu
~13 spots leftby Jun 2024
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