Nasal high-flow therapy for primary respiratory support in preterm infants

Journal article


Roberts, Calum T., Owen, Louise S., Manley, Brett J., Frøisland, Dag H., Donath, Susan M., Dalziel, Kim M., Pritchard, Margo, Cartwright, David W., Collins, Clare L., Malhotra, Atul and Davis, Peter G.. (2016). Nasal high-flow therapy for primary respiratory support in preterm infants. New England Journal of Medicine. 375(12), pp. 1142 - 1151. https://doi.org/10.1056/NEJMoa1603694
AuthorsRoberts, Calum T., Owen, Louise S., Manley, Brett J., Frøisland, Dag H., Donath, Susan M., Dalziel, Kim M., Pritchard, Margo, Cartwright, David W., Collins, Clare L., Malhotra, Atul and Davis, Peter G.
Abstract

Background: Treatment with nasal high-flow therapy has efficacy similar to that of nasal continuous positive airway pressure (CPAP) when used as postextubation support in neonates. The efficacy of high-flow therapy as the primary means of respiratory support for preterm infants with respiratory distress has not been proved. Methods: In this international, multicenter, randomized, noninferiority trial, we assigned 564 preterm infants (gestational age, ≥28 weeks 0 days) with early respiratory distress who had not received surfactant replacement to treatment with either nasal high-flow therapy or nasal CPAP. The primary outcome was treatment failure within 72 hours after randomization. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome; the chosen margin of noninferiority was 10 percentage points. Infants in whom high-flow therapy failed could receive rescue CPAP; infants in whom CPAP failed were intubated and mechanically ventilated. Results: Trial recruitment stopped early at the recommendation of the independent data and safety monitoring committee because of a significant difference in the primary outcome between treatment groups. Treatment failure occurred in 71 of 278 infants (25.5%) in the high-flow group and in 38 of 286 infants (13.3%) in the CPAP group (risk difference, 12.3 percentage points; 95% confidence interval [CI], 5.8 to 18.7; P < 0.001). The rate of intubation within 72 hours did not differ significantly between the high-flow and CPAP groups (15.5% and 11.5%, respectively; risk difference, 3.9 percentage points; 95% CI, −1.7 to 9.6; P=0.17), nor did the rate of adverse events. Conclusions: When used as primary support for preterm infants with respiratory distress, high-flow therapy resulted in a significantly higher rate of treatment failure than did CPAP. (Funded by the National Health and Medical Research Council and others; Australian New Zealand Clinical Trials Registry number, ACTRN12613000303741.)

Year2016
JournalNew England Journal of Medicine
Journal citation375 (12), pp. 1142 - 1151
PublisherMassachusetts Medical Society
ISSN1533-4406
Digital Object Identifier (DOI)https://doi.org/10.1056/NEJMoa1603694
Scopus EID2-s2.0-84988847902
Page range1142 - 1151
Research GroupSchool of Nursing, Midwifery and Paramedicine
Publisher's version
File Access Level
Controlled
Place of publicationUnited States of America
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