• Kristen S Gibbons, Luregn J Schlapbach, Stephen B Horton, Debbie A Long, John Beca, Simon Erickson, Marino Festa, Yves d'Udekem, Nelson Alphonso, David Winlaw, Kerry Johnson, Carmel Delzoppo, Kim van Loon, Brenda Gannon, Jonas Fooken, Antje Blumenthal, Paul J Young, Warwick Butt, Andreas Schibler, and NITRIC Study Group, the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG), and the ANZICS Paediatric Study Group (PSG).
• Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.
• Crit Care Resusc. 2021 Mar 1; 23 (1): 475847-58.

AbstractBackground: The NITric oxide during cardiopulmonary bypass (CPB) to improve Recovery in Infants with Congenital heart defects (NITRIC) trial, a 1320-patient, multicentre, randomised controlled trial, is aiming to improve survival free of ventilation after CPB by using nitric oxide delivered into the oxygenator of the CPB. Objective: To provide a statistical analysis plan before completion of patient recruitment and data monitoring. Final analyses for this study will adhere to this statistical analysis plan, which details all key pre-planned analyses. Stata scripts for analyses have been prepared alongside this statistical analysis plan. Methods: The statistical analysis plan was designed collaboratively by the chief investigators and trial statistician and builds on the previously published study protocol. All authors remain blinded to treatment allocation. Detail is provided on statistical analyses including cohort description, analysis of primary and secondary outcomes and adverse events. Statistical methods to compare outcomes are planned in detail to ensure methods are verifiable and reproducible. Results: The statistical analysis plan developed provides the trial outline, list of mock tables, and analysis scripts. The plan describes statistical analyses on cohort and baseline description, primary and secondary outcome analyses, process of care measures, physiological descriptors, and safety and adverse event reporting. We define the pre-specified subgroup analyses and the respective statistical tests used to compare subgroups. Conclusion: The statistical analysis plan for the NITRIC trial establishes detailed pre-planned analyses alongside Stata scripts to analyse the largest trial in the field of neonatal and paediatric heart surgery. The plan ensures standards for trial analysis validity aiming to minimise bias of analyses. Trial registration: ACTRN12617000821392.© 2021 College of Intensive Care Medicine of Australia and New Zealand.

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