BronchiolitisREST EECNCT05909566
Respiratory Support and Treatment for Efficient and Cost-Effective Care
A study testing Clinical Decision Support (CDS) and HHFNC Weaning in people with Bronchiolitis, run by Christopher Horvat at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Clinical Decision Support (CDS) and HHFNC Weaning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <2 years of age Bronchiolitis WOB Score >2
Who cannot join
- Immunocompromised
- Immunosuppressed
- Chronic lung disease
- Congenital heart disease with baseline cardiorespiratory manifestations
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
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.
- Conditions
- Bronchiolitis
- Being tested
- Clinical Decision Support (CDS), HHFNC Weaning
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support (CDS)Other
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.
HHFNC WeaningDevice
Wean patient off oxygen and flow as oxygenation and work of breathing improves.
| Study group | Role | What they receive |
|---|---|---|
| HHFNC + Clinical decision Support | Experimental | Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC Receives: Other: Clinical Decision Support (CDS); Device: HHFNC Weaning |
| HHFNC Weaning | Active comparator | Team does not receive clinical decision support reminders to wean the HHFNC Receives: Other: Clinical Decision Support (CDS); Device: HHFNC Weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFNC duration
Amount of time patient is on HFNC
Measured: 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 outcomes (8)
Respiratory support free days
Days alive and free of intensive care unit-based respiratory
Measured: From date the start of respiratory support until the first documented respiratory support free day, up to 30 days
Hospital length of stay
Days admitted in hospital
Measured: 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
Days alive and free of ICU-based respiratory or cardiovascular organ support
Measured: 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 from HHFNC and oral intake
Measured: From date of ending HHFNC until first documented oral intake, assessed up to 30 days
Ostensible respiratory distress measured by a respiratory severity score
The product of mean airway pressure and the fraction of inspired oxygen
Measured: Through study completion, an average of 1 week
Cost of hospitalization
Totality of expenses incurred by a hospital in providing its services and care
Measured: 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
Patient Death
Measured: From date of admission until death from any cause, assessed up to 90 days
PICU length of stay
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.
Measured: From data of admission to PICU to discharge from the PICU or death from any cause, whichever came first, assessed up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Oct 2023
- Primary completion19 May 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will be providing clinical decision support tools for children receiving HHFNC for bronchiolitis, testing the impact of decision support compared to usual care in a pragmatic randomized trial. All subjects will receive standard of care. Decisions regarding management will be at the discretion of the treating provider and will not be restricted or altered in any way.
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Horvat
- Sponsor type
- University, hospital or other
- Collaborators
- The Greg Beckwith Foundation
- Responsible party
- Sponsor-investigator, Christopher Horvat, University of Pittsburgh
- Investigators
- Christopher Horvat, MD, Principal investigator, UPMC Children's Hospital of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909566
- Sponsor's protocol ID
- STUDY23010030
- Acronym
- REST EEC
- Status last verified
- Nov 2026
- First submitted
- 24 May 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Horvat CM, Suresh S, James N, Aneja RK, Au AK, Berry S, Blumer A, Bricker K, Clark RSB, Dolinich H, Hahner S, Jockel C, Kalivoda J, Loar I, Marasco D, Marcinick A, Marroquin O, O'brien J, Pelletier J, Ramgopal S, Venkataraman S, Angus DC, Butler G. A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan. Trials. 2024 Jul 16;25(1):484. doi: 10.1186/s13063-024-08327-y.
PubMed 39014495
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Support and Treatment for Efficient and Cost-Effective Care
- ClinicalTrials.gov ID
- NCT05909566
- Acronym / sponsor ID
- REST EEC / STUDY23010030
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Christopher HorvatUniversity, hospital or other
- Collaborators
- The Greg Beckwith Foundation
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will be providing clinical decision support tools for children receiving HHFNC for bronchiolitis, testing the impact of decision support compared to usual care in a pragmatic randomized trial. All subjects will receive standard of care. Decisions regarding management will be at the discretion of the treating provider and will not be restricted or altered in any way.
| Arm | Type | Receives |
|---|---|---|
| HHFNC + Clinical decision Support | Experimental | Other: Clinical Decision Support (CDS), Device: HHFNC WeaningStandardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC |
| HHFNC Weaning | Active comparator | Other: Clinical Decision Support (CDS), Device: HHFNC WeaningTeam does not receive clinical decision support reminders to wean the HHFNC |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- <2 years of age Bronchiolitis WOB Score >2
Key exclusion criteria (4 listed)
- Immunocompromised
- Immunosuppressed
- Chronic lung disease
- Congenital heart disease with baseline cardiorespiratory manifestations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support (CDS)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. | Other | HHFNC + Clinical decision Support, HHFNC Weaning |
| HHFNC WeaningWean patient off oxygen and flow as oxygenation and work of breathing improves. | Device | HHFNC + Clinical decision Support, HHFNC Weaning |
Primary outcome
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
8 secondary outcomes
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
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.
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
Time to oral intake
Time frame: From date of ending HHFNC until first documented oral intake, assessed up to 30 days
Ostensible respiratory distress measured by a respiratory severity score
Time frame: Through study completion, an average of 1 week
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.
Mortality
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 39014495Horvat CM, Suresh S, James N, Aneja RK, Au AK, Berry S, Blumer A, Bricker K, Clark RSB, Dolinich H, Hahner S, Jockel C, Kalivoda J, Loar I, Marasco D, Marcinick A, Marroquin O, O'brien J, Pelletier J, Ramgopal S, Venkataraman S, Angus DC, Butler G. A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan. Trials. 2024 Jul 16;25(1):484. doi: 10.1186/s13063-024-08327-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Horvat, MD principal investigator
UPMC Children's Hospital of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support (CDS) and HHFNC Weaning in people with Bronchiolitis, run by Christopher Horvat at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.