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)
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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.
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.
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.
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).
KeywordsBronchiolitis Continuous positive airway pressure High flow nasal cannula Infant Noninvasive ventilation Oxygen inhalation therapy Randomized controlled trial Respiratory syncytial virus infections Respiratory therapy
Members of the Respiratory GFRUP Study Group substantially contributed to study conception, data interpretation, manuscript revision, and final approval. It includes, in addition to the authors of the manuscript, the following members: Guillaume Emeriaud, MD, PhD (Division of Pediatric Critical Care, Department of Pediatrics, Sainte-Justine University Hospital, University of Montréal, Montréal, QC, Canada); Philippe Jouvet, MD, PhD (Division of Pediatric Critical Care, Department of Pediatrics, Sainte-Justine University Hospital, University of Montréal, QC, Canada); Julie Guichoux, MD (Pediatric Intensive Care Unit, Pellegrin University Hospital, Bordeaux, France); Fabrice Michel, MD, PhD (Department of Pediatric Anesthesia, La Timone University Hospital, Marseille, France); Marti Pons Odena, MD, PhD (Pediatric Intensive Care Unit, Hospital Universitario Sant Joan de Deu University Hospital, Barcelona, Spain); Florent Baudin, MD (Pediatric Intensive Care Unit, Women-Mothers & Children’s University Hospital, Lyon, France); Chloe Genier, GN (Pediatric Intensive Care Unit, Women & Children’s University Hospital, Nantes, France); Ingrid Nissen, MD (Pediatric Intensive Care Unit, St Olavs University Hospital, Trondheim, Norway); Olivier Brissaud, MD (Pediatric Intensive Care Unit, Pellegrin University Hospital, Bordeaux, France); Stéphane Dauger MD, PhD (Pediatric Intensive Care Unit, Robert-Debré University Hospital, Paris, France).
Compliance with ethical standards
All phases of this study were supported by Montpellier University Hospital (Grant: research contract 2012–2015). This study has also been supported by Fisher and Paykel Healthcare with the provision of 30 HFNC circuits. Fisher and Paykel was not involved in the study design and had no role in data management, data analysis and data interpretation, nor in the writing of the report and the decision to submit it for publication.
Conflicts of interest
On behalf of all authors, the corresponding author states that there is no conflict of interest.
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