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CDS + HHFNC Weaning for Bronchiolitis (REST EEC Trial)
N/A
Recruiting
Led By Christopher Horvat, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
<2 years of age Bronchiolitis WOB Score >2
Be younger than 18 years old
Must not have
Chronic lung disease
Congenital heart disease with baseline cardiorespiratory manifestations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days from admission to discharge from hospital or date of death, up to 90 days. of note, an earlier outcome was listed for 90-day cost of care and the redundancy with this outcome was recognized, so the 90-day cost of care outcome was removed.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to improve recovery from common pediatric respiratory illnesses, reduce costs, and show UPMC Children's Hospital's capabilities in pediatric healthcare. It will examine using CDS to improve adherence to standardized guidelines and outcomes.
Who is the study for?
This trial is for children under 2 years old with bronchiolitis and a work of breathing (WOB) score greater than 2. It's not suitable for kids with congenital heart disease affecting their breathing, those who have weakened immune systems, or chronic lung conditions.
What is being tested?
The study tests if using Clinical Decision Support (CDS) can help doctors better follow guidelines when starting and adjusting heated high flow nasal cannula (HHFNC) therapy in young patients with bronchiolitis to improve recovery outcomes.
What are the potential side effects?
While the trial focuses on treatment management rather than medication side effects, HHFNC may cause nasal discomfort or irritation, dryness of the airways, or possible difficulty in weaning off due to dependency.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is under 2 years old with a severe breathing difficulty score over 2.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a long-term lung condition.
Select...
I was born with a heart condition that affects my breathing and heart function.
Select...
My immune system is weak.
Select...
My immune system is weakened.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days from admission to discharge from hospital or date of death, up to 90 days. of note, an earlier outcome was listed for 90-day cost of care and the redundancy with this outcome was recognized, so the 90-day cost of care outcome was removed.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days from admission to discharge from hospital or date of death, up to 90 days. of note, an earlier outcome was listed for 90-day cost of care and the redundancy with this outcome was recognized, so the 90-day cost of care outcome was removed.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
HFNC duration
Secondary study objectives
Cost of hospitalization
Hospital length of stay
Mortality
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HHFNC + Clinical decision SupportExperimental Treatment2 Interventions
Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC
Group II: HHFNC WeaningActive Control2 Interventions
Team does not receive clinical decision support reminders to wean the HHFNC
Find a Location
Who is running the clinical trial?
Beckwith FoundationUNKNOWN
1 Previous Clinical Trials
8 Total Patients Enrolled
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,425 Total Patients Enrolled
Christopher HorvatLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a long-term lung condition.I was born with a heart condition that affects my breathing and heart function.My immune system is weak.My immune system is weakened.My child is under 2 years old with a severe breathing difficulty score over 2.
Research Study Groups:
This trial has the following groups:- Group 1: HHFNC + Clinical decision Support
- Group 2: HHFNC Weaning
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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