• 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, and Giovanni Vento.
• Department of Surgical and Medical Critical Care, Section of Neonatology, Careggi University Hospital, Viale Morgagni 85, Florence 50141, Italy. cdani@unifi.it
• Trials. 2013 Mar 8; 14: 67.

BackgroundSome 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/DesignIn 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 RegistrationTrial Registration NumberNCT01440868.

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