Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants

Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants

Abstract Background Infants born extremely preterm are at high risk of dying or suffering from severe brain injuries. Treatment guided by monitoring of cerebral oxygenation may reduce the risk of death and neurologic complications. The SafeBoosC III trial evaluates the effects of treatment guided by...

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Bibliographic Details
Main Authors: Mathias Lühr Hansen, Adelina Pellicer, Christian Gluud, Eugene Dempsey, Jonathan Mintzer, Simon Hyttel-Sorensen, Anne Marie Heuchan, Cornelia Hagmann, Gabriel Dimitriou, Gerhard Pichler, Gunnar Naulaers, Guoqiang Cheng, Ana Vilan, Jakub Tkaczyk, Karen B. Kreutzer, Monica Fumagalli, Olivier Claris, Siv Fredly, Tomasz Szczapa, Theis Lange, Janus Christian Jakobsen, Gorm Greisen
Format: Article
Language:English
Published: BMC 2019-12-01
Series:Trials
Subjects:
Randomised clinical trial
Extremely preterm
Near-infrared spectroscopy
Cerebral oximetry
Statistical analysis plan
Online Access:https://doi.org/10.1186/s13063-019-3756-y

Internet

https://doi.org/10.1186/s13063-019-3756-y

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