Abstract
The SHINE trial (a multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation): statistical analysis plan
Highlights
Background and rationale for trialEndotracheal intubation is an essential but potentially destabilising procedure for neonates
Protocol version This document is based on information contained in the study protocol of the SHINE Trial version 6
Research question In neonates undergoing emergent or elective endotracheal intubation, does the use of nasal high flow (nHF) during laryngoscopy increase the likelihood of successful intubation on the first attempt without physiological instability, compared with no nHF?
Summary
Trial title A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation: The SHINE Trial. Trial registration ANZCTR registration number ACTRN126128001498280 https://www.anzctr.org.au/Trial/Registration/ TrialReview.aspx?id=375880&isReview=true. 3. Protocol version This document is based on information contained in the study protocol of the SHINE Trial version 6 (dated 13 October 2020). 4. SAP revisions The manuscript was initially submitted to Trials on April 1, 2021, prior to completion of primary data collection. Version 2 (dated 18 June 2021) made
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