A multicentre, randomised controlled, non-inferiority trial, comparing nasal high flow with nasal continuous positive airway pressure as primary support for newborn infants with early respiratory distress born in Australian non-tertiary special care nurseries (the HUNTER trial): study protocol.

Autor:	Manley BJ; Neonatal Services and Newborn Research Centre, The Royal Women's Hospital, Parkville, Victoria, Australia.; Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, Victoria, Australia., Roberts CT; Neonatal Services and Newborn Research Centre, The Royal Women's Hospital, Parkville, Victoria, Australia.; Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, Victoria, Australia., Arnolda GRB; Department of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia., Wright IMR; Illawarra Health and Medical Research Institute and Graduate Medicine, University of Wollongong, Wollongong, New South Wales, Australia.; Department of Paediatrics, The Wollongong Hospital, Wollongong, New South Wales, Australia.; Paediatrics and Child Health, University of Newcastle, Newcastle, New South Wales, Australia., Owen LS; Neonatal Services and Newborn Research Centre, The Royal Women's Hospital, Parkville, Victoria, Australia.; Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, Victoria, Australia.; Clinical Sciences Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia., Dalziel KM; Centre for Health Policy, Melbourne School of Global and Population Health, The University of Melbourne, Parkville, Victoria, Australia., Foster JP; School of Nursing and Midwifery, Western Sydney University, Sydney, New South Wales, Australia.; Sydney Nursing School/Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.; Ingham Institute, Liverpool, New South Wales, Australia., Davis PG; Neonatal Services and Newborn Research Centre, The Royal Women's Hospital, Parkville, Victoria, Australia.; Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, Victoria, Australia.; Clinical Sciences Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia., Buckmaster AG; Paediatrics and Child Health, University of Newcastle, Newcastle, New South Wales, Australia.; Central Coast Local Health District, Gosford, New South Wales, Australia.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2017 Jun 23; Vol. 7 (6), pp. e016746. Date of Electronic Publication: 2017 Jun 23.
DOI:	10.1136/bmjopen-2017-016746
Abstrakt:	Introduction: Nasal high-flow (nHF) therapy is a popular mode of respiratory support for newborn infants. Evidence for nHF use is predominantly from neonatal intensive care units (NICUs). There are no randomised trials of nHF use in non-tertiary special care nurseries (SCNs). We hypothesise that nHF is non-inferior to nasal continuous positive airway pressure (CPAP) as primary support for newborn infants with respiratory distress, in the population cared for in non-tertiary SCNs. Methods and Analysis: The HUNTER trial is an unblinded Australian multicentre, randomised, non-inferiority trial. Infants are eligible if born at a gestational age ≥31 weeks with birth weight ≥1200 g and admitted to a participating non-tertiary SCN, are <24 hours old at randomisation and require non-invasive respiratory support or supplemental oxygen for >1 hour. Infants are randomised to treatment with either nHF or CPAP. The primary outcome is treatment failure within 72 hours of randomisation, as determined by objective oxygenation, apnoea or blood gas criteria or by a clinical decision that urgent intubation and mechanical ventilation, or transfer to a tertiary NICU, is required. Secondary outcomes include incidence of pneumothorax requiring drainage, duration of respiratory support, supplemental oxygen and hospitalisation, costs associated with hospital care, cost-effectiveness, parental stress and satisfaction and nursing workload. Ethics and Dissemination: Multisite ethical approval for the study has been granted by The Royal Children's Hospital, Melbourne, Australia (Trial Reference No. 34222), and by each participating site. The trial is currently recruiting in eight centres in Victoria and New South Wales, Australia, with one previous site no longer recruiting. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences. Trial Registration Number: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001203640; pre-results. Competing Interests: Competing interests: None declared. (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
Databáze:	MEDLINE
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