Respiratory Support and Treatment for Efficient and Cost-Effective Care (REST EEC)
July 17, 2026 updated by: Christopher Horvat
This project aims to answer the essential questions about the management of acute, pediatric respiratory illness, accelerate recovery from these all-too-common diseases, curb unnecessary costs of care, and demonstrate UPMC Children's Hospital of Pittsburgh's capabilities as the premier, world-class leader in the arena of pediatric learning healthcare systems.
REST EEC will focus on the question of whether clinical decision support (CDS) facilitates the standardization of the initiation and weaning of heated high flow nasal cannula (HHFNC) for bronchiolitis.REST EEC will focus on whether the application of CDS improves adherence to a standardized guideline and leads to improved patient-centered outcomes.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
362
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15224
- UPMC Children's Hospital of Pittsburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- <2 years of age Bronchiolitis WOB Score >2
Exclusion Criteria:
- Immunocompromised
- Immunosuppressed
- Chronic lung disease
- Congenital heart disease with baseline cardiorespiratory manifestations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HHFNC + Clinical decision Support
Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC
|
Education to front line clinicians and staff on standardized implementation and weaning of HHFNC and standardized assessments of patient work of breathing.
HHFNC implementation and weaning strategies will be based on age-specific practices recommended by the American Academy of Pediatrics.
Education will be undertaken by dedicated clinical educators.
Wean patient off oxygen and flow as oxygenation and work of breathing improves.
|
|
Active Comparator: HHFNC Weaning
Team does not receive clinical decision support reminders to wean the HHFNC
|
Education to front line clinicians and staff on standardized implementation and weaning of HHFNC and standardized assessments of patient work of breathing.
HHFNC implementation and weaning strategies will be based on age-specific practices recommended by the American Academy of Pediatrics.
Education will be undertaken by dedicated clinical educators.
Wean patient off oxygen and flow as oxygenation and work of breathing improves.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HFNC duration
Time Frame: Timeframe consists of a start time of either randomization or the last documentation of positive pressure ventilation (whichever is later) and the last documentation of HFNC in the electronic flowsheet, up to 30 days
|
Amount of time patient is on HFNC
|
Timeframe consists of a start time of either randomization or the last documentation of positive pressure ventilation (whichever is later) and the last documentation of HFNC in the electronic flowsheet, up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ostensible respiratory distress measured by a respiratory severity score
Time Frame: Through study completion, an average of 1 week
|
The product of mean airway pressure and the fraction of inspired oxygen
|
Through study completion, an average of 1 week
|
|
Respiratory support free days
Time Frame: From date the start of respiratory support until the first documented respiratory support free day, up to 30 days
|
Days alive and free of intensive care unit-based respiratory
|
From date the start of respiratory support until the first documented respiratory support free day, up to 30 days
|
|
Hospital length of stay
Time Frame: From date of admission until discharge or date of death from any cause, whichever came first, assessed up to 90 days.
|
Days admitted in hospital
|
From date of admission until discharge or date of death from any cause, whichever came first, assessed up to 90 days.
|
|
Organ support free days
Time Frame: From date of admission until the first day of ICU-based respiratory or cardiovascular organ support or discharge or date of death from any case, whichever came first, assessed up to 30 days
|
Days alive and free of ICU-based respiratory or cardiovascular organ support
|
From date of admission until the first day of ICU-based respiratory or cardiovascular organ support or discharge or date of death from any case, whichever came first, assessed up to 30 days
|
|
Time to oral intake
Time Frame: From date of ending HHFNC until first documented oral intake, assessed up to 30 days
|
Time from HHFNC and oral intake
|
From date of ending HHFNC until first documented oral intake, assessed up to 30 days
|
|
Cost of hospitalization
Time Frame: 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.
|
Totality of expenses incurred by a hospital in providing its services and care
|
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.
|
|
Mortality
Time Frame: From date of admission until death from any cause, assessed up to 90 days
|
Patient Death
|
From date of admission until death from any cause, assessed up to 90 days
|
|
PICU length of stay
Time Frame: From data of admission to PICU to discharge from the PICU or death from any cause, whichever came first, assessed up to 90 days.
|
Days admitted in the PICU.
This is added to reconcile the plan to evaluate this outcome and its noted absence from this website, as pointed out by a reviewer while working to publish the trial design.
|
From data of admission to PICU to discharge from the PICU or death from any cause, whichever came first, assessed up to 90 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Horvat, MD, UPMC Children's Hospital of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2023
Primary Completion (Actual)
May 19, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
May 24, 2023
First Submitted That Met QC Criteria
June 11, 2023
First Posted (Actual)
June 18, 2023
Study Record Updates
Last Update Posted (Actual)
July 21, 2026
Last Update Submitted That Met QC Criteria
July 17, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23010030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.