title: High 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).
abstract: OBJECTIVE
  Nasal 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.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  From 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.
  
  
  CONCLUSIONS
  In 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).
authors.affiliation: 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.
authors.forename: Christophe
authors.initials: C
authors.lastname: Milési
authors.affiliation: Pediatric Intensive Care Unit, Kremlin Bicêtre University Hospital, Paris, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Essouri
authors.affiliation: Pediatric Intensive Care Unit, Women-Mothers and Children's University Hospital, Lyon, France.
authors.forename: Robin
authors.initials: R
authors.lastname: Pouyau
authors.affiliation: Pediatric Intensive Care Unit, Women and Children's University Hospital, Nantes, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Liet
authors.affiliation: Pediatric Intensive Care Unit, Lenval University Hospital, Nice, France.
authors.forename: Mickael
authors.initials: M
authors.lastname: Afanetti
authors.affiliation: Pediatric Intensive Care Unit, Women-Mothers and Children's University Hospital, Lyon, France.|INSERM, CIC1407, 69500, Bron, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Portefaix
authors.affiliation: 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.
authors.forename: Julien
authors.initials: J
authors.lastname: Baleine
authors.affiliation: 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.
authors.forename: Sabine
authors.initials: S
authors.lastname: Durand
authors.affiliation: 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.
authors.forename: Clémentine
authors.initials: C
authors.lastname: Combes
authors.affiliation: Department of Medical Information, Arnaud de Villeneuve University Hospital, Montpellier, France.
authors.forename: Aymeric
authors.initials: A
authors.lastname: Douillard
authors.affiliation: 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. g-cambonie@chu-montpellier.fr.
authors.forename: Gilles
authors.initials: G
authors.lastname: Cambonie
mesh_terms: D000208:Acute Disease; D001990:Bronchiolitis, Viral / Q000628:therapy*; D000072601:Cannula; D045422:Continuous Positive Airway Pressure / Q000009:adverse effects / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects / Q000379:methods* / Q000706:statistics & numerical data; D012127:Respiratory Distress Syndrome, Newborn / Q000628:therapy*; D017211:Treatment Failure
keywords: Bronchiolitis; Continuous positive airway pressure; High flow nasal cannula; Infant; Noninvasive ventilation; Oxygen inhalation therapy; Randomized controlled trial; Respiratory syncytial virus infections; Respiratory therapy