Considering the Validity of the SAIL Trial-A Navel Gazers Guide to the SAIL Trial

Considering the Validity of the SAIL Trial-A Navel Gazers Guide to the SAIL Trial
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DOI:
10.3389/fped.2019.00495
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发表时间:
2019-11-27
影响因子:
2.6
通讯作者:
Ratcliffe, Sarah
Ratcliffe, Sarah
中科院分区:
医学3区
文献类型:
--
作者:
Kirpalani, Haresh;Keszler, Martin;Ratcliffe, Sarah

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本文探讨婴幼儿肺持续充气(SAIL)随机对照临床试验的有效性。SAIL试验招募了原计划600名婴儿中的460名,但试验因受到伤害而提前停止。我们在此询问,在进行的审判中是否存在任何对有效性的威胁。然后,我们探索试验的哪些设计元素本可以改进。最后,我们考虑对这一领域未来的试验有什么影响。
This article explores the validity of the Sustained Aeration Inflation for Infant Lungs (SAIL) randomized controlled clinical trial. The SAIL trial enrolled 460 infants out of a planned 600, but the trial was stopped early for harm. We ask here, whether there were any threats to validity in the trial as conducted. We then explore what design elements of the trial could have been improved upon. Finally, we consider what the implications are for future trials in this arena.