Franklin
Trial question
What is the role of high-flow oxygen therapy among infants with bronchiolitis who were treated outside an ICU?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 1472
1472 patients (547 female, 925 male)
Inclusion criteria: infants younger than 12 months of age who had bronchiolitis and a need for supplemental oxygen therapy
Key exclusion criteria: critically illness with an immediate need for respiratory support; cyanotic heart disease, basal skull fracture, upper airway obstruction, or craniofacial malformation; and receipt of oxygen therapy at home
Interventions
N=739 high-flow (heated and humidified oxygen delivered at a rate of 2 L/kg of body weight per minute by Optiflow Junior cannula and Airvo 2 high-flow system)
N=733 standard therapy (supplemental oxygen through a nasal cannula, up to a maximum of 2 L/min)
Primary outcome
Escalation of care due to treatment failure
12
23
23.0 %
17.3 %
11.5 %
5.8 %
0.0 %
High-flow
Standard
therapy
Significant
decrease ▼
NNT = 9
Significant decrease in escalation of care due to treatment failure (12% vs. 23%; ARD -11, 95% CI -15 to -7)
Secondary outcomes
No significant difference in duration of hospital stay (3.12 days vs. 2.94 days; AD 0.18 days, 95% CI -0.09 to 0.44)
No significant difference in duration of ICU stay (2.63 days vs. 2.72 days; AD -0.09 days, 95% CI -0.74 to 0.55)
No significant difference in duration of oxygen therapy (1.81 days vs. 1.87 days; AD -0.06 days, 95% CI -0.28 to 0.16)
Safety outcomes
No significant difference in adverse events.
Significant difference in the respiratory rate at the time of escalation of care (62.6 breaths/min vs. 54.6 breaths/min).
Conclusion
In infants younger than 12 months of age who had bronchiolitis and a need for supplemental oxygen therapy, high-flow was superior to standard therapy with respect to escalation of care due to treatment failure.
Reference
Donna Franklin, Franz E Babl, Luregn J Schlapbach et al. A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis. N Engl J Med. 2018 Mar 22;378(12):1121-1131.
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