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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial

Authors: Elizabeth E Foglia, Louise S Owen, Marta Thio, Sarah J Ratcliffe, Gianluca Lista, Arjan te Pas, Helmut Hummler, Vinay Nadkarni, Anne Ades, Michael Posencheg, Martin Keszler, Peter Davis, Haresh Kirpalani

Published in: Trials | Issue 1/2015

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Abstract

Background

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question.

Methods/Design

This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age.

Trial Registration

www.​clinicaltrials.​gov, Trial identifier NCT02139800, Registered 13 May 2014
Appendix
Available only for authorised users
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Metadata
Title
Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial
Authors
Elizabeth E Foglia
Louise S Owen
Marta Thio
Sarah J Ratcliffe
Gianluca Lista
Arjan te Pas
Helmut Hummler
Vinay Nadkarni
Anne Ades
Michael Posencheg
Martin Keszler
Peter Davis
Haresh Kirpalani
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0601-9

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