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protocol changes in the hospital
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 %. |
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| 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 %. |
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| 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 %. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial Flow Rate | Other | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | 4 hours of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure to HFNC Therapy |
| 24 hours from time of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Cheng, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Health - Children's Medical Center | Dallas | Texas | 75235 | United States |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| Length of oxygen support |
|
| 24 hours from time of study |
| Length of stay |
| 24 hours from time of study |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |