Brett J Manley1, Gaston R B Arnolda1, Ian M R Wright1, Louise S Owen1, Jann P Foster1, Li Huang1, Calum T Roberts1, Tracey L Clark1, Wei-Qi Fan1, Alice Y W Fang1, Isaac R Marshall1, Rosalynn J Pszczola1, Peter G Davis1, Adam G Buckmaster1. 1. From the Newborn Research Centre and Neonatal Services, Royal Women's Hospital (B.J.M., L.S.O., P.G.D.), the Departments of Obstetrics and Gynaecology (B.J.M., L.S.O., P.G.D.) and Paediatrics (W.Q.F.), University of Melbourne, and Clinical Sciences, Murdoch Children's Research Institute (B.J.M., L.S.O., P.G.D.), Parkville, VIC, the University of New South Wales (G.R.B.A.) and the Sydney Medical School-Sydney Nursing School, University of Sydney (J.P.F.), Sydney, the Australian Institute of Health Innovation, Macquarie University, Sydney (G.R.B.A.), Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW (I.M.R.W.), Western Sydney University, Penrith, NSW (J.P.F.), Ingham Institute, Liverpool, NSW (J.P.F.), the Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Carlton, VIC (L.H.), Monash Newborn, Monash Children's Hospital, and the Department of Paediatrics, Monash University, Clayton, VIC (C.T.R.), Monash Newborn, Monash Health, Dandenong, VIC (T.L.C.), the Department of Paediatrics, Northern Hospital, Epping, VIC (W.Q.F.), Box Hill Hospital, Eastern Health, Box Hill, VIC (A.Y.W.F.), Women's and Children's Services, Barwon Health, Geelong, VIC (I.R.M.), the Department of Neonatology, Western Health, St. Albans, VIC (R.J.P.), the Department of Paediatrics, Central Coast Local Health District, Gosford, NSW (A.G.B.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (A.G.B.) - all in Australia.
Abstract
BACKGROUND: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. (Funded by the Australian National Health and Medical Research Council and Monash University; HUNTER Australian and New Zealand Clinical Trials Registry number, ACTRN12614001203640.).
RCT Entities:
BACKGROUND: 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. (Funded by the Australian National Health and Medical Research Council and Monash University; HUNTER Australian and New Zealand Clinical Trials Registry number, ACTRN12614001203640.).
Authors: Mia Maamari; Gustavo Nino; James Bost; Yao Cheng; Anthony Sochet; Matthew Sharron Journal: J Intensive Care Med Date: 2021-01-08 Impact factor: 3.510
Authors: Kate A Hodgson; Louise S Owen; Camille Omar Kamlin; Calum T Roberts; Susan M Donath; Peter G Davis; Brett James Manley Journal: BMJ Open Date: 2020-10-05 Impact factor: 2.692