BronchiolitisNCT04517344
High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study
A study testing Initial Flow Rate in people with Bronchiolitis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. Read more about this study
- Who is it for?
- Ages 7 days to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Initial Flow Rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients less than 12 months of age
- Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics
- Requires ICU level of care by clinicians' discretion
- Requiring HFNC support
Who cannot join
- Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation
- Congenital heart disease,
- Immunocompromised state
- Upper airway obstruction
- Chronic lung disease
- Bronchopulmonary dysplasia,
Show all 11Show fewer
- Home oxygen therapy requirement
- Acute trauma patients
- Baseline craniofacial malformations
- Admitted to the neonatal or cardiac ICUs
- Patients who are admitted to the floor
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health - Children's Medical Center
Dallas, Texas, 75235
About this study
Official title: High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study - A Single Center, Randomized Controlled, Feasibility Study
The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined clinician's assessment for the need for ICU level of care.
The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.
- Conditions
- Bronchiolitis
- Being tested
- Initial Flow Rate
- Keywords
- Bronchiolitis, HFNC, High Flow Nasal Cannula, Infants
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial Flow RateOther
Patients placed on High Flow Nasal Cannula by treating physician will be randomized to initial flow rates of 1 L/kg/min, 1.5 L/kg/min, or 2 L/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, HFNC 1 L/kg/min | Experimental | The infant that is randomized to the HFNC therapy arm 1 will be placed on high flow at 1 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If oxygen saturation (SpO2) is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %. Receives: Other: Initial Flow Rate |
| Arm 2, HFNC 1.5 L/kg/min | Experimental | The infant that is randomized to the HFNC therapy arm 2 will be placed on high flow at 1.5 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %. Receives: Other: Initial Flow Rate |
| Arm 3, HFNC 2 L/kg/min | Experimental | The infant that is randomized to the HFNC therapy arm 3 will be placed on high flow at 2 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %. Receives: Other: Initial Flow Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response to HFNC Therapy
Determined by Respiratory Distress Assessment Instrument (RDAI) score and Respiratory Assessment Change Score (RACS) and heart rate improvement by 10%.
The RDAI score assigns a score base on respiratory rate (RR), extent of wheezing, and retractions. It ranges from 0-17, higher score indicates severe bronchiolitis.
To determine RACS:
- A decrease in RR by 10% is +1 change unit. Increase of 10% was defined as -1 change unit.
- Subsequent RDAI score is subtracted from the previous RDAI score to obtain the change. (ie. if initial score is 7 and the reassessment score is 3, the patient has a score of +4) Positive score is indicative of improvement, and negative score demonstrates deterioration.
The overall RACS is calculated as the sum of change scores. Improvement is defined as RACS ≥ 4 positive units. No improvement was defined as RACS < 4 positive units.
Measured: 4 hours of therapy
Secondary outcomes (3)
Treatment failure to HFNC Therapy
- Need for an increase in initial flow setting as determined by treating physician during the first 24 hours of hospitalization
- Escalation to other forms of non-invasive ventilatory support (i.e. NCPAP or BIPAP)
- Need for invasive ventilation
Measured: 24 hours from time of study
Length of oxygen support
- Number of hours on HFNC
- Number of hours on simple nasal cannula
Measured: 24 hours from time of study
Length of stay
- Length of stay in the pediatric ICU
- Length of stay in the hospital
Measured: 24 hours from time of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Dec 2020
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: protocol changes in the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Cheng, University of Texas Southwestern Medical Center
- Investigators
- Amy Cheng, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517344
- Sponsor's protocol ID
- STU-2020-0816
- Status last verified
- May 2025
- First submitted
- 15 Aug 2020
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study - A Single Center, Randomized Controlled, Feasibility Study
- ClinicalTrials.gov ID
- NCT04517344
- Acronym / sponsor ID
- STU-2020-0816
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, HFNC, High Flow Nasal Cannula, Infants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: protocol changes in the hospital
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 18 Aug 2020 (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.
The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined clinician's assessment for the need for ICU level of care.
The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1, HFNC 1 L/kg/min | Experimental | Other: Initial Flow RateThe infant that is randomized to the HFNC therapy arm 1 will be placed on high flow at 1 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If oxygen saturation (SpO2) is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %. |
| Arm 2, HFNC 1.5 L/kg/min | Experimental | Other: Initial Flow RateThe infant that is randomized to the HFNC therapy arm 2 will be placed on high flow at 1.5 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %. |
| Arm 3, HFNC 2 L/kg/min | Experimental | Other: Initial Flow RateThe infant that is randomized to the HFNC therapy arm 3 will be placed on high flow at 2 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %. |
Who may qualify
- Ages
- 7 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients less than 12 months of age
- Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics
- Requires ICU level of care by clinicians' discretion
- Requiring HFNC support
Key exclusion criteria (11 listed)
- Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation
- Congenital heart disease,
- Immunocompromised state
- Upper airway obstruction
- Chronic lung disease
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 |
|---|---|---|
| Initial Flow RatePatients placed on High Flow Nasal Cannula by treating physician will be randomized to initial flow rates of 1 L/kg/min, 1.5 L/kg/min, or 2 L/kg/min | Other | Arm 1, HFNC 1 L/kg/min, Arm 2, HFNC 1.5 L/kg/min, Arm 3, HFNC 2 L/kg/min |
Primary outcome
Treatment response to HFNC Therapy
Time frame: 4 hours of therapy
Determined by Respiratory Distress Assessment Instrument (RDAI) score and Respiratory Assessment Change Score (RACS) and heart rate improvement by 10%. The RDAI score assigns a score base on respiratory rate (RR), extent of wheezing, and retractions. It ranges from 0-17, higher score indicates severe bronchiolitis. To determine RACS: * A decrease in RR by 10% is +1 change unit. Increase of 10% was defined as -1 change unit. * Subsequent RDAI score is subtracted from the previous RDAI score to obtain the change. (ie. if initial score is 7 and the reassessment score is 3, the patient has a score of +4) Positive score is indicative of improvement, and negative score demonstrates deterioration. The overall RACS is calculated as the sum of change scores. Improvement is defined as RACS ≥ 4 positive units. No improvement was defined as RACS < 4 positive units.
3 secondary outcomes
Treatment failure to HFNC Therapy
Time frame: 24 hours from time of study
Length of oxygen support
Time frame: 24 hours from time of study
Length of stay
Time frame: 24 hours from time of study
Results and safety
The study was stopped early (reason given: protocol changes in the hospital). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- 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.
Amy Cheng, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial Flow Rate in people with Bronchiolitis, run by University of Texas Southwestern Medical Center 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 May 2025. 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?
The study was stopped early (reason given: protocol changes in the hospital). Results are not available in the source record.
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?
Treatment response to HFNC Therapy (time frame: 4 hours of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.