| Autor: |
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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Předmět: |
|
| Zdroj: |
Trials, Vol 20, Iss 1, Pp 1-12 (2019) |
| Druh dokumentu: |
article |
| ISSN: |
1745-6215 |
| DOI: |
10.1186/s13063-019-3756-y |
| Popis: |
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 cerebral oxygenation monitoring versus treatment as usual. This article describes the detailed statistical analysis plan for the main publication, with the aim to prevent outcome reporting bias and data-driven analyses. Methods/design The SafeBoosC III trial is an investigator-initiated, randomised, multinational, pragmatic phase III trial with a parallel group structure, designed to investigate the benefits and harms of treatment based on cerebral near-infrared spectroscopy monitoring compared with treatment as usual. Randomisation will be 1:1 stratified for neonatal intensive care unit and gestational age (lower gestational age ( |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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