AUTHOR=Kirpalani Haresh , Keszler Martin , Foglia Elizabeth E. , Davis Peter , Ratcliffe Sarah 

TITLE=Considering the Validity of the SAIL Trial—A Navel Gazers Guide to the SAIL Trial

JOURNAL=Frontiers in Pediatrics

VOLUME=7

YEAR=2019

URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2019.00495

DOI=10.3389/fped.2019.00495

ISSN=2296-2360

ABSTRACT=<p>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.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">www.clinicaltrials.gov</ext-link>, Identifier: NCT02139800</p>