Christophe Milési1, Anne-Florence Pierre2, Anna Deho3, Robin Pouyau4, Jean-Michel Liet5, Camille Guillot6, Anne-Sophie Guilbert7, Jérôme Rambaud8, Astrid Millet9, Mickael Afanetti10, Julie Guichoux11, Mathieu Genuini12, Thierry Mansir13, Jean Bergounioux14, Fabrice Michel15, Marie-Odile Marcoux16, Julien Baleine1, Sabine Durand1, Philippe Durand2, Stéphane Dauger3, Etienne Javouhey4, Stéphane Leteurtre6, Olivier Brissaud11, Sylvain Renolleau12, Aurélie Portefaix17, Aymeric Douillard18, Gilles Cambonie19. 1. Department of Neonatal Medicine and Pediatric Intensive Care, Arnaud de Villeneuve University Hospital, 371 Avenue Doyen G Giraud, 34295, Montpellier Cedex 5, France. 2. Pediatric Intensive Care Unit, Kremlin Bicêtre University Hospital, Paris, France. 3. Pediatric Intensive Care Unit, Robert Debré University Hospital, Paris, France. 4. Pediatric Intensive Care Unit, Women-Mother-Child University Hospital, Lyon, France. 5. Pediatric Intensive Care Unit, Women-Child University Hospital, Nantes, France. 6. Pediatric Intensive Care Unit, Jeanne de Flandre University Hospital, Lille, France. 7. Pediatric Intensive Care Unit, Hautepierre University Hospital, Strasbourg, France. 8. Pediatric Intensive Care Unit, Armand Trousseau University Hospital, Paris, France. 9. Pediatric Intensive Care Unit, La Tronche University Hospital, Grenoble, France. 10. Pediatric Intensive Care Unit, Lenval University Hospital, Nice, France. 11. Pediatric Intensive Care Unit, Children's University Hospital, Bordeaux, France. 12. Pediatric Intensive Care Unit, Necker-Sick Children University Hospital, Paris, France. 13. Pediatric Intensive Care Unit, General Hospital of Pau, Pau, France. 14. Pediatric Intensive Care Unit, Raymond Poincaré University Hospital, Garches, France. 15. Pediatric Intensive Care Unit, La Timone University Hospital, Marseille, France. 16. Pediatric Intensive Care Unit, Children's University Hospital, Toulouse, France. 17. INSERM, CIC1407, 69500, Bron, France. 18. Department of Medical Information, Arnaud de Villeneuve University Hospital, Montpellier, France. 19. Department of Neonatal Medicine and Pediatric Intensive Care, Arnaud de Villeneuve University Hospital, 371 Avenue Doyen G Giraud, 34295, Montpellier Cedex 5, France. g-cambonie@chu-montpellier.fr.
Abstract
PURPOSE:High-flow nasal cannula (HFNC) therapy is increasingly proposed as first-line respiratory support for infants with acute viral bronchiolitis (AVB). Most teams use 2 L/kg/min, but no study compared different flow rates in this setting. We hypothesized that 3 L/kg/min would be more efficient for the initial management of these patients. METHODS: A randomized controlled trial was performed in 16 pediatric intensive care units (PICUs) to compare these two flow rates in infants up to 6 months old with moderate to severe AVB and treated withHFNC. The primary endpoint was the percentage of failure within 48 h of randomization, using prespecified criteria of worsening respiratory distress and discomfort. RESULTS:From November 2016 to March 2017, 142 infants were allocated to the 2-L/kg/min (2L) flow rate and 144 to the 3-L/kg/min (3L) flow rate. Failure rate was comparable between groups: 38.7% (2L) vs. 38.9% (3L; p = 0.98). Worsening respiratory distress was the most common cause of failure in both groups: 49% (2L) vs. 39% (3L; p = 0.45). In the 3L group, discomfort was more frequent (43% vs. 16%, p = 0.002) and PICU stays were longer (6.4 vs. 5.3 days, p = 0.048). The intubation rates [2.8% (2L) vs. 6.9% (3L), p = 0.17] and durations of invasive [0.2 (2L) vs. 0.5 (3L) days, p = 0.10] and noninvasive [1.4 (2L) vs. 1.6 (3L) days, p = 0.97] ventilation were comparable. No patient had air leak syndrome or died. CONCLUSION: In young infants with AVB supported withHFNC, 3 L/kg/min did not reduce the risk of failure compared with 2 L/kg/min. This clinical trial was recorded on the National Library of Medicine registry (NCT02824744).
RCT Entities:
PURPOSE: High-flow nasal cannula (HFNC) therapy is increasingly proposed as first-line respiratory support for infants with acute viral bronchiolitis (AVB). Most teams use 2 L/kg/min, but no study compared different flow rates in this setting. We hypothesized that 3 L/kg/min would be more efficient for the initial management of these patients. METHODS: A randomized controlled trial was performed in 16 pediatric intensive care units (PICUs) to compare these two flow rates in infants up to 6 months old with moderate to severe AVB and treated with HFNC. The primary endpoint was the percentage of failure within 48 h of randomization, using prespecified criteria of worsening respiratory distress and discomfort. RESULTS: From November 2016 to March 2017, 142 infants were allocated to the 2-L/kg/min (2L) flow rate and 144 to the 3-L/kg/min (3L) flow rate. Failure rate was comparable between groups: 38.7% (2L) vs. 38.9% (3L; p = 0.98). Worsening respiratory distress was the most common cause of failure in both groups: 49% (2L) vs. 39% (3L; p = 0.45). In the 3L group, discomfort was more frequent (43% vs. 16%, p = 0.002) and PICU stays were longer (6.4 vs. 5.3 days, p = 0.048). The intubation rates [2.8% (2L) vs. 6.9% (3L), p = 0.17] and durations of invasive [0.2 (2L) vs. 0.5 (3L) days, p = 0.10] and noninvasive [1.4 (2L) vs. 1.6 (3L) days, p = 0.97] ventilation were comparable. No patient had air leak syndrome or died. CONCLUSION: In young infants with AVB supported with HFNC, 3 L/kg/min did not reduce the risk of failure compared with 2 L/kg/min. This clinical trial was recorded on the National Library of Medicine registry (NCT02824744).
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