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    A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol

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    Author
    Hodgson, KA; Owen, LS; Kamlin, CO; Roberts, CT; Donath, SM; Davis, PG; Manley, BJ
    Date
    2020-01-01
    Source Title
    BMJ Open
    Publisher
    BMJ PUBLISHING GROUP
    University of Melbourne Author/s
    Davis, Peter; Hodgson, Kate; Manley, Brett; Kamlin, Camille Omar; Roberts, Calum; Donath, Susan
    Affiliation
    Paediatrics (RCH)
    Obstetrics and Gynaecology
    Metadata
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    Document Type
    Journal Article
    Citations
    Hodgson, K. A., Owen, L. S., Kamlin, C. O., Roberts, C. T., Donath, S. M., Davis, P. G. & Manley, B. J. (2020). A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol. BMJ OPEN, 10 (10), https://doi.org/10.1136/bmjopen-2020-039230.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/252202
    DOI
    10.1136/bmjopen-2020-039230
    Abstract
    INTRODUCTION: Neonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates. METHODS AND ANALYSIS: The Stabilisation with nasal High flow during Intubation of NEonates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks' gestation; ≥28 weeks' gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute). ETHICS AND DISSEMINATION: The SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women's Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12618001498280.

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