Calum T Roberts1, Louise S Owen1, Brett J Manley1, Dag H Frøisland1, Susan M Donath1, Kim M Dalziel1, Margo A Pritchard1, David W Cartwright1, Clare L Collins1, Atul Malhotra1, Peter G Davis1. 1. From Neonatal Services and Newborn Research Centre, Royal Women's Hospital (C.T.R., L.S.O., B.J.M., D.H.F., P.G.D.), the Departments of Obstetrics and Gynaecology (C.T.R., L.S.O., B.J.M., P.G.D.) and Paediatrics (S.M.D.) and School of Population and Global Health (K.M.D.), University of Melbourne, Critical Care and Neurosciences (L.S.O., P.G.D.) and Clinical Epidemiology and Biostatistics Unit (S.M.D.), Murdoch Children's Research Institute, Neonatal Services, Mercy Hospital for Women (C.L.C.), and Monash Newborn, Monash Children's Hospital, and Department of Paediatrics, Monash University (A.M.), Melbourne, VIC, and the School of Nursing, Midwifery and Paramedicine, Australian Catholic University (M.A.P.), Mater Research Institute (M.A.P.) and the Department of Paediatrics (D.W.C.), University of Queensland, and Women's and Newborn Services, Royal Brisbane and Women's Hospital (D.W.C.), Brisbane, QLD - all in Australia; and the Department of Pediatrics, Innlandet Hospital Trust, Lillehammer, Norway (D.H.F.).
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 receivedsurfactant 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 .).
RCT Entities:
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 .).
Authors: Anna K Knight; Alicia K Smith; Karen N Conneely; Philippa Dalach; Yuk J Loke; Jeanie L Cheong; Peter G Davis; Jeffrey M Craig; Lex W Doyle; Christiane Theda Journal: J Pediatr Date: 2018-04-25 Impact factor: 4.406
Authors: Tim Leon Ullrich; Christoph Czernik; Christoph Bührer; Gerd Schmalisch; Hendrik Stefan Fischer Journal: World J Pediatr Date: 2018-03-09 Impact factor: 2.764
Authors: Padmanabhan Ramnarayan; Alvin Richards-Belle; Laura Drikite; Michelle Saull; Izabella Orzechowska; Robert Darnell; Zia Sadique; Julie Lester; Kevin P Morris; Lyvonne N Tume; Peter J Davis; Mark J Peters; Richard G Feltbower; Richard Grieve; Karen Thomas; Paul R Mouncey; David A Harrison; Kathryn M Rowan Journal: JAMA Date: 2022-07-12 Impact factor: 157.335