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

Haresh Kirpalani; Martin Keszler; Elizabeth E. Foglia; Peter Davis; Sarah Ratcliffe

doi:10.3389/fped.2019.00495

Frontiers in Pediatrics (Nov 2019)

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

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

Affiliations

Haresh Kirpalani: Division of Neonatology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States
Martin Keszler: Department of Pediatrics, Warren Alpert Medical School, Women and Infants Hospital of Rhode Island, Brown University, Providence, RI, United States
Elizabeth E. Foglia: Division of Neonatology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States
Peter Davis: Newborn Research Centre, The Royal Women's Hospital, Melbourne, VIC, Australia
Sarah Ratcliffe: Division of Biostatistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA, United States

DOI: https://doi.org/10.3389/fped.2019.00495
Journal volume & issue: Vol. 7

Abstract

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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.Clinical Trial Registration:www.clinicaltrials.gov, Identifier: NCT02139800

Published in Frontiers in Pediatrics

ISSN: 2296-2360 (Online)
Publisher: Frontiers Media S.A.
Country of publisher: Switzerland
LCC subjects: Medicine: Pediatrics
Website: http://journal.frontiersin.org/journal/pediatrics

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Abstract

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