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

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 tria...

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Detalles Bibliográficos
Autores principales: Kirpalani, Haresh, Keszler, Martin, Foglia, Elizabeth E., Davis, Peter, Ratcliffe, Sarah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2019
Materias:
Pediatrics
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6890806/
https://www.ncbi.nlm.nih.gov/pubmed/31828052
http://dx.doi.org/10.3389/fped.2019.00495
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author Kirpalani, Haresh
Keszler, Martin
Foglia, Elizabeth E.
Davis, Peter
Ratcliffe, Sarah
author_facet Kirpalani, Haresh
Keszler, Martin
Foglia, Elizabeth E.
Davis, Peter
Ratcliffe, Sarah
author_sort Kirpalani, Haresh
collection PubMed
description 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
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spelling pubmed-68908062019-12-11 Considering the Validity of the SAIL Trial—A Navel Gazers Guide to the SAIL Trial Kirpalani, Haresh Keszler, Martin Foglia, Elizabeth E. Davis, Peter Ratcliffe, Sarah Front Pediatr Pediatrics 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 Frontiers Media S.A. 2019-11-27 /pmc/articles/PMC6890806/ /pubmed/31828052 http://dx.doi.org/10.3389/fped.2019.00495 Text en Copyright © 2019 Kirpalani, Keszler, Foglia, Davis and Ratcliffe. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pediatrics
Kirpalani, Haresh
Keszler, Martin
Foglia, Elizabeth E.
Davis, Peter
Ratcliffe, Sarah
Considering the Validity of the SAIL Trial—A Navel Gazers Guide to the SAIL Trial
title Considering the Validity of the SAIL Trial—A Navel Gazers Guide to the SAIL Trial
title_full Considering the Validity of the SAIL Trial—A Navel Gazers Guide to the SAIL Trial
title_fullStr Considering the Validity of the SAIL Trial—A Navel Gazers Guide to the SAIL Trial
title_full_unstemmed Considering the Validity of the SAIL Trial—A Navel Gazers Guide to the SAIL Trial
title_short Considering the Validity of the SAIL Trial—A Navel Gazers Guide to the SAIL Trial
title_sort considering the validity of the sail trial—a navel gazers guide to the sail trial
topic Pediatrics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6890806/
https://www.ncbi.nlm.nih.gov/pubmed/31828052
http://dx.doi.org/10.3389/fped.2019.00495
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