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Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.

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).

Author information

1
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.
2
Pediatric Intensive Care Unit, Kremlin Bicêtre University Hospital, Paris, France.
3
Pediatric Intensive Care Unit, Women-Mothers and Children's University Hospital, Lyon, France.
4
Pediatric Intensive Care Unit, Women and Children's University Hospital, Nantes, France.
5
Pediatric Intensive Care Unit, Lenval University Hospital, Nice, France.
6
INSERM, CIC1407, 69500, Bron, France.
7
Department of Medical Information, Arnaud de Villeneuve University Hospital, Montpellier, France.
8
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.

Abstract

PURPOSE:

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.

CONCLUSION:

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).

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

PMID:
28124736
DOI:
10.1007/s00134-016-4617-8
[Indexed for MEDLINE]

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