METHODS
This is an ancillary study to the multicenter randomized controlled trial TRAMONTANE 2, which compared two settings, (3 versus 2 L/kg/min), in young infants with severe AVB (defined by a modified Wood’s clinical asthma score (mWCAS) >3) supported with HFNC [24]. The study protocol was approved by the South Mediterranean IV Ethics Committee (2016-A00900-51), and recorded on the National Library of Medicine registry (NCT02824744). Written authorization was obtained from the two parents.
The study, performed in 16 French university hospital centers between November 2016 and March 2017, enrolled 142 infants in the 2 L-group, 144 infants in 3 L-group, and found the same failure rate of 39% in each group, allowing to include the 286 TRAMONTANE 2 patients in the current analysis.