Data from a randomized controlled trial: Comparison between high-flow nasal cannula (HFNC) therapy and noninvasive ventilation (NIV) in children with acute respiratory failure by bronchiolitis

Background: The objective of this study was to compare HFNC therapy to
noninvasive ventilation (NIV/BiPAP) in children with bronchiolitis who
developed respiratory failure. We hypothesized that HFNC therapy would not
be inferior to NIV. Methods: This was a noninferiority open-label
randomized single-center clinical trial conducted at a tertiary Brazilian
hospital. Children under 2 years of age with no chronic conditions
admitted for bronchiolitis that progressed to mild to moderate respiratory
distress (Wood-Downes-Férres score < 8) were randomized to either
the HFNC group or NIV (BiPAP) group through sealed envelopes. Vital signs,
FiO2, Wood-Downes-Férres score and HFNC/NIV parameters were recorded up to
96 h after therapy initiation. Children who developed respiratory failure
despite receiving initial therapy were intubated. Crossover was not
allowed. The primary outcome analyzed was invasive mechanical ventilation
requirement. The secondary outcomes were sedation usage, invasive
mechanical ventilation duration, the PICU LOS, the hospital LOS, and
mortality rate. Results: A total of 126 patients were allocated to the NIV
group (132 randomized and 6 excluded), and 126 were allocated to the HFNC
group (136 randomized and 10 excluded). The median age was 2.5 (1-6)
months in the NIV group and 3 (2-7) months in the HFNC group (p = 0,07).
RSV was the most common virus isolated in both groups (72% vs. 71.4%, NIV
and HFNC, respectively). Thirty-seven patients were intubated in the NIV
group and 29 were intubated in the HFNC group (29% vs. 23%, p = 0.25).
According to the Farrington-Manning test, with a noninferiority margin of
15%, the difference was 6.3% in favor of HFNC therapy (95% confidence
interval: -4.5 to 17.1%, p < 0.0001). There was no significant
difference in the PICU LOS or sedation duration. Sedation requirement,
hospital LOS and invasive mechanical ventilation duration were lower in
the HFNC group. Conclusion: HFNC therapy is noninferior to NIV in infants
admitted with mild to moderate respiratory distress caused by
bronchiolitis that progresses to respiratory failure. Trial registration
numbers: U1111-1262-1740; RBR-104z966s. Registered 03/01/2023
(retrospectively registered). ReBEC:
https://ensaiosclinicos.gov.br/rg/RBR-104z966s.