Nasal high-flow therapy for newborn infants in special care nurseries

Brett J. Manley, Gaston R.B. Arnolda, Ian M.R. Wright, Louise S. Owen, Jann P. Foster, Li Huang, Calum T. Roberts, Tracey L. Clark, Wei Qi Fan, Alice Y.W. Fang, Isaac R. Marshall, Rosalynn J. Pszczola, Peter G. Davis, Adam G. Buckmaster, HUNTER Trial Investigators

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Nasal high-flow therapy is an alternative to nasal continuous positive airway pressure (CPAP) as a means of respiratory support for newborn infants. The efficacy of high-flow therapy in nontertiary special care nurseries is unknown. METHODS We performed a multicenter, randomized, noninferiority trial involving newborn infants (<24 hours of age; gestational age, ≥31 weeks) in special care nurseries in Australia. Newborn infants with respiratory distress and a birth weight of at least 1200 g were assigned to treatment with either high-flow therapy or CPAP. The primary outcome was treatment failure within 72 hours after randomization. Infants in whom high-flow therapy failed could receive CPAP. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome, with a noninferiority margin of 10 percentage points. RESULTS A total of 754 infants (mean gestational age, 36.9 weeks, and mean birth weight, 2909 g) were included in the primary intention-to-treat analysis. Treatment failure occurred in 78 of 381 infants (20.5%) in the high-flow group and in 38 of 373 infants (10.2%) in the CPAP group (risk difference, 10.3 percentage points; 95% confidence interval [CI], 5.2 to 15.4). In a secondary per-protocol analysis, treatment failure occurred in 49 of 339 infants (14.5%) in the high-flow group and in 27 of 338 infants (8.0%) in the CPAP group (risk difference, 6.5 percentage points; 95% CI, 1.7 to 11.2). The incidences of mechanical ventilation, transfer to a tertiary neonatal intensive care unit, and adverse events did not differ significantly between the groups. CONCLUSIONS Nasal high-flow therapy was not shown to be noninferior to CPAP and resulted in a significantly higher incidence of treatment failure than CPAP when used in nontertiary special care nurseries as early respiratory support for newborn infants with respiratory distress.

Original languageEnglish
Pages (from-to)2031-2040
Number of pages10
JournalNew England Journal of Medicine
Volume380
Issue number21
DOIs
Publication statusPublished - 23 May 2019

Cite this

Manley, B. J., Arnolda, G. R. B., Wright, I. M. R., Owen, L. S., Foster, J. P., Huang, L., ... HUNTER Trial Investigators (2019). Nasal high-flow therapy for newborn infants in special care nurseries. New England Journal of Medicine, 380(21), 2031-2040. https://doi.org/10.1056/NEJMoa1812077
Manley, Brett J. ; Arnolda, Gaston R.B. ; Wright, Ian M.R. ; Owen, Louise S. ; Foster, Jann P. ; Huang, Li ; Roberts, Calum T. ; Clark, Tracey L. ; Fan, Wei Qi ; Fang, Alice Y.W. ; Marshall, Isaac R. ; Pszczola, Rosalynn J. ; Davis, Peter G. ; Buckmaster, Adam G. ; HUNTER Trial Investigators. / Nasal high-flow therapy for newborn infants in special care nurseries. In: New England Journal of Medicine. 2019 ; Vol. 380, No. 21. pp. 2031-2040.
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title = "Nasal high-flow therapy for newborn infants in special care nurseries",
abstract = "Nasal high-flow therapy is an alternative to nasal continuous positive airway pressure (CPAP) as a means of respiratory support for newborn infants. The efficacy of high-flow therapy in nontertiary special care nurseries is unknown. METHODS We performed a multicenter, randomized, noninferiority trial involving newborn infants (<24 hours of age; gestational age, ≥31 weeks) in special care nurseries in Australia. Newborn infants with respiratory distress and a birth weight of at least 1200 g were assigned to treatment with either high-flow therapy or CPAP. The primary outcome was treatment failure within 72 hours after randomization. Infants in whom high-flow therapy failed could receive CPAP. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome, with a noninferiority margin of 10 percentage points. RESULTS A total of 754 infants (mean gestational age, 36.9 weeks, and mean birth weight, 2909 g) were included in the primary intention-to-treat analysis. Treatment failure occurred in 78 of 381 infants (20.5{\%}) in the high-flow group and in 38 of 373 infants (10.2{\%}) in the CPAP group (risk difference, 10.3 percentage points; 95{\%} confidence interval [CI], 5.2 to 15.4). In a secondary per-protocol analysis, treatment failure occurred in 49 of 339 infants (14.5{\%}) in the high-flow group and in 27 of 338 infants (8.0{\%}) in the CPAP group (risk difference, 6.5 percentage points; 95{\%} CI, 1.7 to 11.2). The incidences of mechanical ventilation, transfer to a tertiary neonatal intensive care unit, and adverse events did not differ significantly between the groups. CONCLUSIONS Nasal high-flow therapy was not shown to be noninferior to CPAP and resulted in a significantly higher incidence of treatment failure than CPAP when used in nontertiary special care nurseries as early respiratory support for newborn infants with respiratory distress.",
author = "Manley, {Brett J.} and Arnolda, {Gaston R.B.} and Wright, {Ian M.R.} and Owen, {Louise S.} and Foster, {Jann P.} and Li Huang and Roberts, {Calum T.} and Clark, {Tracey L.} and Fan, {Wei Qi} and Fang, {Alice Y.W.} and Marshall, {Isaac R.} and Pszczola, {Rosalynn J.} and Davis, {Peter G.} and Buckmaster, {Adam G.} and {HUNTER Trial Investigators}",
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Manley, BJ, Arnolda, GRB, Wright, IMR, Owen, LS, Foster, JP, Huang, L, Roberts, CT, Clark, TL, Fan, WQ, Fang, AYW, Marshall, IR, Pszczola, RJ, Davis, PG, Buckmaster, AG & HUNTER Trial Investigators 2019, 'Nasal high-flow therapy for newborn infants in special care nurseries' New England Journal of Medicine, vol. 380, no. 21, pp. 2031-2040. https://doi.org/10.1056/NEJMoa1812077

Nasal high-flow therapy for newborn infants in special care nurseries. / Manley, Brett J.; Arnolda, Gaston R.B.; Wright, Ian M.R.; Owen, Louise S.; Foster, Jann P.; Huang, Li; Roberts, Calum T.; Clark, Tracey L.; Fan, Wei Qi; Fang, Alice Y.W.; Marshall, Isaac R.; Pszczola, Rosalynn J.; Davis, Peter G.; Buckmaster, Adam G.; HUNTER Trial Investigators.

In: New England Journal of Medicine, Vol. 380, No. 21, 23.05.2019, p. 2031-2040.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Nasal high-flow therapy for newborn infants in special care nurseries

AU - Manley, Brett J.

AU - Arnolda, Gaston R.B.

AU - Wright, Ian M.R.

AU - Owen, Louise S.

AU - Foster, Jann P.

AU - Huang, Li

AU - Roberts, Calum T.

AU - Clark, Tracey L.

AU - Fan, Wei Qi

AU - Fang, Alice Y.W.

AU - Marshall, Isaac R.

AU - Pszczola, Rosalynn J.

AU - Davis, Peter G.

AU - Buckmaster, Adam G.

AU - HUNTER Trial Investigators

PY - 2019/5/23

Y1 - 2019/5/23

N2 - Nasal high-flow therapy is an alternative to nasal continuous positive airway pressure (CPAP) as a means of respiratory support for newborn infants. The efficacy of high-flow therapy in nontertiary special care nurseries is unknown. METHODS We performed a multicenter, randomized, noninferiority trial involving newborn infants (<24 hours of age; gestational age, ≥31 weeks) in special care nurseries in Australia. Newborn infants with respiratory distress and a birth weight of at least 1200 g were assigned to treatment with either high-flow therapy or CPAP. The primary outcome was treatment failure within 72 hours after randomization. Infants in whom high-flow therapy failed could receive CPAP. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome, with a noninferiority margin of 10 percentage points. RESULTS A total of 754 infants (mean gestational age, 36.9 weeks, and mean birth weight, 2909 g) were included in the primary intention-to-treat analysis. Treatment failure occurred in 78 of 381 infants (20.5%) in the high-flow group and in 38 of 373 infants (10.2%) in the CPAP group (risk difference, 10.3 percentage points; 95% confidence interval [CI], 5.2 to 15.4). In a secondary per-protocol analysis, treatment failure occurred in 49 of 339 infants (14.5%) in the high-flow group and in 27 of 338 infants (8.0%) in the CPAP group (risk difference, 6.5 percentage points; 95% CI, 1.7 to 11.2). The incidences of mechanical ventilation, transfer to a tertiary neonatal intensive care unit, and adverse events did not differ significantly between the groups. CONCLUSIONS Nasal high-flow therapy was not shown to be noninferior to CPAP and resulted in a significantly higher incidence of treatment failure than CPAP when used in nontertiary special care nurseries as early respiratory support for newborn infants with respiratory distress.

AB - Nasal high-flow therapy is an alternative to nasal continuous positive airway pressure (CPAP) as a means of respiratory support for newborn infants. The efficacy of high-flow therapy in nontertiary special care nurseries is unknown. METHODS We performed a multicenter, randomized, noninferiority trial involving newborn infants (<24 hours of age; gestational age, ≥31 weeks) in special care nurseries in Australia. Newborn infants with respiratory distress and a birth weight of at least 1200 g were assigned to treatment with either high-flow therapy or CPAP. The primary outcome was treatment failure within 72 hours after randomization. Infants in whom high-flow therapy failed could receive CPAP. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome, with a noninferiority margin of 10 percentage points. RESULTS A total of 754 infants (mean gestational age, 36.9 weeks, and mean birth weight, 2909 g) were included in the primary intention-to-treat analysis. Treatment failure occurred in 78 of 381 infants (20.5%) in the high-flow group and in 38 of 373 infants (10.2%) in the CPAP group (risk difference, 10.3 percentage points; 95% confidence interval [CI], 5.2 to 15.4). In a secondary per-protocol analysis, treatment failure occurred in 49 of 339 infants (14.5%) in the high-flow group and in 27 of 338 infants (8.0%) in the CPAP group (risk difference, 6.5 percentage points; 95% CI, 1.7 to 11.2). The incidences of mechanical ventilation, transfer to a tertiary neonatal intensive care unit, and adverse events did not differ significantly between the groups. CONCLUSIONS Nasal high-flow therapy was not shown to be noninferior to CPAP and resulted in a significantly higher incidence of treatment failure than CPAP when used in nontertiary special care nurseries as early respiratory support for newborn infants with respiratory distress.

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U2 - 10.1056/NEJMoa1812077

DO - 10.1056/NEJMoa1812077

M3 - Article

VL - 380

SP - 2031

EP - 2040

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 21

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Manley BJ, Arnolda GRB, Wright IMR, Owen LS, Foster JP, Huang L et al. Nasal high-flow therapy for newborn infants in special care nurseries. New England Journal of Medicine. 2019 May 23;380(21):2031-2040. https://doi.org/10.1056/NEJMoa1812077