Investigators from multiple institutions in France conducted a randomized controlled trial to determine if high-flow nasal cannula (HFNC) is a noninferior treatment compared to nasal continuous positive airway pressure (nCPAP) in treating infants with acute viral bronchiolitis (AVB). Infants 1–6 months old with AVB who were admitted to 1 of 5 pediatric intensive care units in France were eligible for the study if they had a modified Wood clinical asthma score (mWCAS) of >3, indicative of moderate to severe respiratory distress. Study participants were randomized to treatment with nCPAP, with a continuous pressure of +7 cm water, or HFNC, with flow of 2 L/kg/min. In both groups, oxygen was provided to maintain oxygen saturation at 94% to 97%. The primary outcome was failure within 24 hours of beginning the assigned treatment, defined as an increase from baseline respiratory rate of >10 breaths/min, a 1-point increase from baseline mWCAS, a 1-point increase in the Échelle de Douleur d’Inconfort du Nouveau-Né (EDIN) score, a validated scale to assess prolonged pain in infants, or >2 severe apnea episodes per hour. Failure rates among infants in the 2 treatment groups were compared. The definition of noninferiority for the purpose of this trial was an HFNC failure rate within 15% of the nCPAP failure rate. A “superiority analysis” was also performed to directly compare treatment failure rates.
Data were analyzed in 142 infants, with 71 randomized to each treatment group. Baseline characteristics were similar among infants in the 2 groups. Treatment failure occurred in 31.0% (22 of 71) of those in the nCPAP group, usually due to increasing EDIN scores, and 50.7% (36 of 71) of those randomized to HFNC, most often because of worsening respiratory distress. The 19% difference in failure rate did not meet the predetermined criterion for noninferiority. In the superiority analysis, infants treated with nCPAP were significantly less likely to have treatment failure than those randomized to HFNC (P = .001).
The researchers conclude that HFNC was not as effective as nCPAP in treating young infants with severe to moderate AVB.
Dr. Dubik has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
Preemptive nCPAP is the standard for noninvasive respiratory support for infants with moderate to severe bronchiolitis.1 However, there is much institutional variability,2 and HFNC has the advantages of improved comfort and ease of use and is being used more often as a means of respiratory support.3 If HFNC therapy could be shown to be equivalent—that is, noninferior to nCPAP—then it would be an appropriate, if not promising,...