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Intensive care medicine · Feb 2017
Randomized Controlled Trial Multicenter StudyHigh flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study).
- Christophe Milési, Sandrine Essouri, Robin Pouyau, Jean-Michel Liet, Mickael Afanetti, Aurélie Portefaix, Julien Baleine, Sabine Durand, Clémentine Combes, Aymeric Douillard, Gilles Cambonie, and Groupe Francophone de Réanimation et d’Urgences Pédiatriques (GFRUP).
- Pediatric Intensive Care Unit, Département de Pédiatrie Néonatale et Réanimations, CHU de Montpellier, Arnaud de Villeneuve University Hospital, 371 Avenue du Doyen G. Giraud, 34295, Montpellier Cedex 5, France.
- Intensive Care Med. 2017 Feb 1; 43 (2): 209-216.
PurposeNasal continuous positive airway pressure (nCPAP) is currently the gold standard for respiratory support for moderate to severe acute viral bronchiolitis (AVB). Although oxygen delivery via high flow nasal cannula (HFNC) is increasingly used, evidence of its efficacy and safety is lacking in infants.MethodsA randomized controlled trial was performed in five pediatric intensive care units (PICUs) to compare 7 cmH2O nCPAP with 2 L/kg/min oxygen therapy administered with HFNC in infants up to 6 months old with moderate to severe AVB. The primary endpoint was the percentage of failure within 24 h of randomization using prespecified criteria. To satisfy noninferiority, the failure rate of HFNC had to lie within 15% of the failure rate of nCPAP. Secondary outcomes included success rate after crossover, intubation rate, length of stay, and serious adverse events.ResultsFrom November 2014 to March 2015, 142 infants were included and equally distributed into groups. The risk difference of -19% (95% CI -35 to -3%) did not allow the conclusion of HFNC noninferiority (p = 0.707). Superiority analysis suggested a relative risk of success 1.63 (95% CI 1.02-2.63) higher with nCPAP. The success rate with the alternative respiratory support, intubation rate, durations of noninvasive and invasive ventilation, skin lesions, and length of PICU stay were comparable between groups. No patient had air leak syndrome or died.ConclusionIn young infants with moderate to severe AVB, initial management with HFNC did not have a failure rate similar to that of nCPAP. This clinical trial was recorded in the National Library of Medicine registry (NCT 02457013).
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