Pediatric AsthmaNCT06379607
High Flow Nasal Cannula Rates in Pediatric Asthma
A study testing "High Flow" High Flow Nasal Cannula and "Low Flow" High Flow Nasal Cannula in people with Pediatric Asthma, run by University of Rochester at 2 sites in United States.
Trial summary
This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Asthma
- What is being tested?
- "High Flow" High Flow Nasal Cannula and "Low Flow" High Flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2025to 30 Sep 2026
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 2-17 years old with prior clinical diagnosis of asthma
- Admitted to PICU on standard asthma therapy defined as continuous albuterol and systemic corticosteroids
- Admitted to PICU on either COT or HFNC
- Admitted to PICU from either Golisano Children's Hospital ED or as a transport from an outside hospital ED within 6 hours of initial presentation
- PRAM score greater than or equal to 4 after completion of initial ED therapy
Who cannot join
- Admitted to the PICU on NIV or invasive mechanical ventilation
- Admitted to the PICU from general floors or > 6 hours from initial presentation
- Presence of a tracheostomy or baseline NIV requirement
- Pregnancy
- Immunocompromised State
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Rochester Golisano Children's Hospital
Rochester, New York, 14642
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: High Flow Nasal Cannula Rates in Pediatric Asthma Exacerbations: A Feasibility Study
This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations.
Read the detailed description
The purpose of this feasibility trial is to examine the safety and efficacy of high flow nasal cannula in moderate to severe pediatric asthma exacerbations. Eligible patients will be admitted to the Pediatric Intensive Care Unit (PICU) after initial presentation to the emergency department (ED) or as a transfer from an outside hospital ED. Patients will be admitted to the PICU on standard asthma therapy (continuous albuterol and systemic corticosteroids) based on the discretion of the treating ED physician. Upon PICU admission, eligible patients will be consented, enrolled, and randomized into the study. All patients will be continued on standard asthma therapy of continuous albuterol at 20mg/hr and systemic intravenous corticosteroids. Patient will be randomized into one of three groups: (1) conventional oxygen therapy at 2L/min via standard facemark (control group), (2) high flow nasal cannula at 4L/min, and (3) high flow nasal cannula at 2L/kg/min (max 60L/min). Pediatric Respiratory Assessment Measure (PRAM) scores and vital signs will be taken at baseline and hourly for two hours. After the two-hour long study is completed, patients will be placed on a respiratory support modality as per the treating physician's discretion. Patients will be followed longitudinally after study completion.
- Conditions
- Pediatric Asthma
- Being tested
- "High Flow" High Flow Nasal Cannula, "Low Flow" High Flow Nasal Cannula
- Keywords
- Asthma, High Flow Nasal Cannula, Conventional Oxygen Therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"High Flow" High Flow Nasal CannulaDevice
High Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use higher flow rates.
"Low Flow" High Flow Nasal CannulaDevice
High Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use lower flow rates.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Oxygen Therapy (COT) | No intervention | Conventional Oxygen Therapy (COT) is the standard way to deliver oxygen to hypoxemic pediatric patients during an acute asthma exacerbation. Continuous albuterol will be administered via an aerogen set-up (aerogen mask, aerogen ultra, and a vibrating mesh nebulizer). Oxygen tubing will be connected to the wall and run at 2L/min as per the aerogen manufacturer's instructions. |
| "Low Flow" High Flow Nasal Cannula at 4L/min | Experimental | A Fisher Paykl humidifier will be used for high flow humidification along with a flow meter and oxygen blender. A vibrating mesh nebulizer will be connected between the flow meter and the humidifier as per routine practice. Oxygen flow will be set to 4L/min and patient will be fitted with appropriately sized nasal prongs. Receives: Device: "Low Flow" High Flow Nasal Cannula |
| "High Flow" High Flow Nasal Cannula at 2L/kg/min (max 60L/min) | Experimental | A Fisher Paykl humidifier will be used for high flow humidification along with a flow meter and oxygen blender. A vibrating mesh nebulizer will be connected between the flow meter and the humidifier as per routine practice. Oxygen flow will be set to 2L/kg/min (max 60L/min) and patient will be fitted with appropriately sized nasal prongs. Receives: Device: "High Flow" High Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants enrolled
Percent of participants randomized divided by the percent of participants approached.
Measured: 12 months
Secondary outcomes (10)
Mean Change in Pediatric Respiratory Assessment Measure (PRAM) Score
The Pediatric Respiratory Assessment Measure (PRAM) Score is a validated tool to measure asthma severity in pediatric patients. It is a scale that ranges from 0-12 with scores 4-7 indicating moderate asthma exacerbation and scores of 8-12 indicating severe exacerbation. The score has also been shown to be responsive to asthma therapies, with a decrease in score being indicative of improvement. PRAM scores will be measured at the start of the trial, at hour 1 and at the completion of the trial at hour 2. Mean changes in PRAM score will be compared across all three groups.
Measured: Baseline to 2 hours
Mean Change in Respiratory Rate
The mean change in respiratory rate during the two our study period across all 3 study groups will be compared.
Measured: Baseline to 2 hours
Mean Total Duration of Continuous Albuterol
Children will be followed longitudinally until hospital discharge and record the total duration of hours patients spent on continuous albuterol.
Measured: Approximately 3 days
Percentage of Children with Escalation of Respiratory Support
The percentage of children requiring an increase in respiratory support (defined as escalation of support to HFNC of any flow rate, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BPAP), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)) either during the 2-hour trial period, immediately upon completion, or within the first 24 hours of study enrollment time will be recorded.
Measured: 1 day
Mean Total Duration of Respiratory Support
Children will be followed longitudinally until hospital discharge and the total duration of hours patients spent on any respiratory support modality including COT, HFNC, noninvasive ventilation (NIV), invasive ventilation (IMV), or extracorporeal membrane oxygenation (ECMO) will be recorded.
Measured: Until hospital discharge, approximately 5 days
Percentage of Participants placed on Adjunct Asthma Therapies
Investigators will describe how many children in each group were placed on adjunct asthma therapies including magnesium, heliox, leukotriene receptor antagonists, intravenous beta agonist therapies, and methylxantines either before, during, or after study period.
Measured: Until hospital discharge, approximately 5 days
Percentage of Participants who needed Sedation
Investigators will record how many children in each group required sedation and/or anxiolytics while on their respiratory support modality either during the trial or afterwards.
Measured: Until hospital discharge, approximately 5 days
Percentage of Participants on Antibiotics
Investigators will record how many children completed full 5-7 day courses of antibiotics for bacterial pneumonia concurrent with their asthma exacerbation.
Measured: Until hospital discharge, approximately 5 days
Mean PICU Length of Stay (LOS)
Investigators will follow children longitudinally to record the amount of time children were admitted to the PICU for.
Measured: Until hospital discharge, approximately 3 days
Mean Hospital Length of Stay (LOS)
Investigators will follow children longitudinally to record the amount of time children were admitted to the hospital for.
Measured: Until hospital discharge, approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start15 Jan 2025
- Primary completion15 Jan 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: No longer performing study due to lack of funding and protected research time by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele E. Smith, University of Rochester
- Investigators
- MicheleE E Smith, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379607
- Sponsor's protocol ID
- STUDY00009285
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2024
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Rates in Pediatric Asthma Exacerbations: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06379607
- Acronym / sponsor ID
- STUDY00009285
- Conditions
- Pediatric Asthma
- Keywords
- Asthma, High Flow Nasal Cannula, Conventional Oxygen Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer performing study due to lack of funding and protected research time by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Apr 2024 (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 is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations.
Detailed description
The purpose of this feasibility trial is to examine the safety and efficacy of high flow nasal cannula in moderate to severe pediatric asthma exacerbations. Eligible patients will be admitted to the Pediatric Intensive Care Unit (PICU) after initial presentation to the emergency department (ED) or as a transfer from an outside hospital ED. Patients will be admitted to the PICU on standard asthma therapy (continuous albuterol and systemic corticosteroids) based on the discretion of the treating ED physician. Upon PICU admission, eligible patients will be consented, enrolled, and randomized into the study. All patients will be continued on standard asthma therapy of continuous albuterol at 20mg/hr and systemic intravenous corticosteroids. Patient will be randomized into one of three groups: (1) conventional oxygen therapy at 2L/min via standard facemark (control group), (2) high flow nasal cannula at 4L/min, and (3) high flow nasal cannula at 2L/kg/min (max 60L/min). Pediatric Respiratory Assessment Measure (PRAM) scores and vital signs will be taken at baseline and hourly for two hours. After the two-hour long study is completed, patients will be placed on a respiratory support modality as per the treating physician's discretion. Patients will be followed longitudinally after study completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Oxygen Therapy (COT) | No intervention | –Conventional Oxygen Therapy (COT) is the standard way to deliver oxygen to hypoxemic pediatric patients during an acute asthma exacerbation. Continuous albuterol will be administered via an aerogen set-up (aerogen mask, aerogen ultra, and a vibrating mesh nebulizer). Oxygen tubing will be connected to the wall and run at 2L/min as per the aerogen manufacturer's instructions. |
| "Low Flow" High Flow Nasal Cannula at 4L/min | Experimental | Device: "Low Flow" High Flow Nasal CannulaA Fisher Paykl humidifier will be used for high flow humidification along with a flow meter and oxygen blender. A vibrating mesh nebulizer will be connected between the flow meter and the humidifier as per routine practice. Oxygen flow will be set to 4L/min and patient will be fitted with appropriately sized nasal prongs. |
| "High Flow" High Flow Nasal Cannula at 2L/kg/min (max 60L/min) | Experimental | Device: "High Flow" High Flow Nasal CannulaA Fisher Paykl humidifier will be used for high flow humidification along with a flow meter and oxygen blender. A vibrating mesh nebulizer will be connected between the flow meter and the humidifier as per routine practice. Oxygen flow will be set to 2L/kg/min (max 60L/min) and patient will be fitted with appropriately sized nasal prongs. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 2-17 years old with prior clinical diagnosis of asthma
- Admitted to PICU on standard asthma therapy defined as continuous albuterol and systemic corticosteroids
- Admitted to PICU on either COT or HFNC
- Admitted to PICU from either Golisano Children's Hospital ED or as a transport from an outside hospital ED within 6 hours of initial presentation
- PRAM score greater than or equal to 4 after completion of initial ED therapy
Key exclusion criteria (5 listed)
- Admitted to the PICU on NIV or invasive mechanical ventilation
- Admitted to the PICU from general floors or > 6 hours from initial presentation
- Presence of a tracheostomy or baseline NIV requirement
- Pregnancy
- Immunocompromised State
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 |
|---|---|---|
| "High Flow" High Flow Nasal CannulaHigh Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use higher flow rates. | Device | "High Flow" High Flow Nasal Cannula at 2L/kg/min (max 60L/min) |
| "Low Flow" High Flow Nasal CannulaHigh Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use lower flow rates. | Device | "Low Flow" High Flow Nasal Cannula at 4L/min |
Primary outcome
Percent of participants enrolled
Time frame: 12 months
Percent of participants randomized divided by the percent of participants approached.
10 secondary outcomes
Mean Change in Pediatric Respiratory Assessment Measure (PRAM) Score
Time frame: Baseline to 2 hours
Mean Change in Respiratory Rate
Time frame: Baseline to 2 hours
Mean Total Duration of Continuous Albuterol
Time frame: Approximately 3 days
Percentage of Children with Escalation of Respiratory Support
Time frame: 1 day
Mean Total Duration of Respiratory Support
Time frame: Until hospital discharge, approximately 5 days
Percentage of Participants placed on Adjunct Asthma Therapies
Time frame: Until hospital discharge, approximately 5 days
Percentage of Participants who needed Sedation
Time frame: Until hospital discharge, approximately 5 days
Percentage of Participants on Antibiotics
Time frame: Until hospital discharge, approximately 5 days
Mean PICU Length of Stay (LOS)
Time frame: Until hospital discharge, approximately 3 days
Mean Hospital Length of Stay (LOS)
Time frame: Until hospital discharge, approximately 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Pediatric Asthma
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
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.
MicheleE E Smith, MD principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "High Flow" High Flow Nasal Cannula and "Low Flow" High Flow Nasal Cannula in people with Pediatric Asthma, run by University of Rochester at 2 sites 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 withdrawn before enrolling participants, so there are no results.
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?
Percent of participants enrolled (time frame: 12 months). 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 27 Mar 2026.