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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

Sustained lung inflation in the delivery room in preterm infants at high risk of respiratory distress syndrome (SLI STUDY): study protocol for a randomized controlled trial

Authors: Carlo Dani, Gianluca Lista, Simone Pratesi, Luca Boni, Massimo Agosti, Paolo Biban, Antonio Del Vecchio, Diego Gazzolo, Camilla Gizzi, Rosario Magaldi, Hubert Messner, Fabio Mosca, Fabrizio Sandri, Fabio Scopesi, Daniele Trevisanuto, Giovanni Vento

Published in: Trials | Issue 1/2013

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Abstract

Background

Some studies have suggested that the early sustained lung inflation (SLI) procedure is effective in decreasing the need for mechanical ventilation (MV) and improving respiratory outcome in preterm infants. We planned the present randomized controlled trial to confirm or refute these findings.

Methods/Design

In this study, 276 infants born at 25+0 to 28+6 weeks’ gestation at high risk of respiratory distress syndrome (RDS) will be randomized to receive the SLI maneuver (25 cmH2O for 15 seconds) followed by nasal continuous positive airway pressure (NCPAP) or NCPAP alone in the delivery room. SLI and NCPAP will be delivered using a neonatal mask and a T-piece ventilator.
The primary endpoint is the need for MV in the first 72 hours of life. The secondary endpoints include the need and duration of respiratory support (NCPAP, MV and surfactant), and the occurrence of bronchopulmonary dysplasia (BPD).

Trial registration

Trial registration number:NCT01440868
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Metadata
Title
Sustained lung inflation in the delivery room in preterm infants at high risk of respiratory distress syndrome (SLI STUDY): study protocol for a randomized controlled trial
Authors
Carlo Dani
Gianluca Lista
Simone Pratesi
Luca Boni
Massimo Agosti
Paolo Biban
Antonio Del Vecchio
Diego Gazzolo
Camilla Gizzi
Rosario Magaldi
Hubert Messner
Fabio Mosca
Fabrizio Sandri
Fabio Scopesi
Daniele Trevisanuto
Giovanni Vento
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-67

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