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Paediatrics
Protocol
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
  1. Brett J Manley1,2,
  2. Calum T Roberts1,2,
  3. Gaston R B Arnolda3,
  4. Ian M R Wright4,5,6,
  5. Louise S Owen1,2,7,
  6. Kim M Dalziel8,
  7. Jann P Foster9,10,11,
  8. Peter G Davis1,2,7,
  9. Adam G Buckmaster6,12
  1. 1 Neonatal Services and Newborn Research Centre, The Royal Women's Hospital, Parkville, Victoria, Australia
  2. 2 Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, Victoria, Australia
  3. 3 Department of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia
  4. 4 Illawarra Health and Medical Research Institute and Graduate Medicine, University of Wollongong, Wollongong, New South Wales, Australia
  5. 5 Department of Paediatrics, The Wollongong Hospital, Wollongong, New South Wales, Australia
  6. 6 Paediatrics and Child Health, University of Newcastle, Newcastle, New South Wales, Australia
  7. 7 Clinical Sciences Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia
  8. 8 Centre for Health Policy, Melbourne School of Global and Population Health, The University of Melbourne, Parkville, Victoria, Australia
  9. 9 School of Nursing and Midwifery, Western Sydney University, Sydney, New South Wales, Australia
  10. 10 Sydney Nursing School/Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
  11. 11 Ingham Institute, Liverpool, New South Wales, Australia
  12. 12 Central Coast Local Health District, Gosford, New South Wales, Australia
  1. Correspondence to Dr Brett J Manley; brett.manley{at}thewomens.org.au

Abstract

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.

  • neonatology
  • paediatrics
  • perinatology

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-016746

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    Footnotes

    • Contributors BJM conceived and designed the trial protocol, co-wrote the first draft and revised the manuscript for intellectual content. CTR co-wrote the first draft and revised the manuscript for intellectual content. GRBA, AGB, IMW, LSO, JPF and PGD conceived and designed the trial protocol and revised the manuscript for important intellectual content. GRBA designed the statistical analysis. KMD designed the cost-effectiveness analysis and revised the manuscript for important intellectual content. All the authors have read and approved the final manuscript, and all are accountable for its accuracy.

    • Funding The trial is funded by the National Health and Medical Research Council (NHMRC), Australia (Project grant 1098790). Brett Manley is the recipient of an NHMRC Early Career Fellowship (1088279).

    • Competing interests None declared.

    • Ethics approval Human Research and Ethics Committee, The Royal Children's Hospital, Melbourne, Australia.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Only the members of the Trial Steering Committee will have access to the final dataset.

    • Correction notice This paper has been amended since it was published Online First. Owing to a scripting error, some of the publisher names in the references were replaced with 'BMJ Publishing Group'. This only affected the full text version, not the PDF. We have since corrected these errors and the correct publishers have been inserted into the references.