Bronchiolitis
Conditions
Keywords
Bronchiolitis, HFNC, High Flow Nasal Cannula, Infants
Brief 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. 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.
Interventions
OTHERInitial Flow Rate
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
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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, * Home oxygen therapy requirement * Acute trauma patients * Baseline craniofacial malformations * Admitted to the neonatal or cardiac ICUs * Patients who are admitted to the floor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response to HFNC Therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure to HFNC Therapy | 24 hours from time of study | * 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 |
| Length of oxygen support | 24 hours from time of study | * Number of hours on HFNC * Number of hours on simple nasal cannula |
| Length of stay | 24 hours from time of study | * Length of stay in the pediatric ICU * Length of stay in the hospital |
Countries
United States
Outcome results
None listed