6/28/23, 10:42 PM Franklin Pathway Feedback Search Clinical Topics Home Studies Franklin Franklin Disease Bronchiolitis 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 N = 1472 63.0% male 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 https://web.pathway.md/studies/recSyMH4vLuaZun1Y 1/2 6/28/23, 10:42 PM Franklin Pathway Escalation of care due to treatment failure 23.0 % 23 17.3 % 12 11.5 % Significant decrease 5.8 % NNT = 9 0.0 % High-flow Standard therapy 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. Open reference URL https://web.pathway.md/studies/recSyMH4vLuaZun1Y 2/2