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
1 Department of Surgical and Medical Critical Care, Section of Neonatology, Careggi University Hospital, Viale Morgagni 85, Florence, 50141, Italy
2 Division of Neonatology, ‘VBuzzi’ Children’s Hospital, Via Castelvetro. 32, Milan, 20154, Italy
3 Clinical Trials Coordinating Center, IstitutoToscanoTumori, Florence; Department of Human Pathology and Oncology, University of Florence, Viale Morgagni 85, Florence, 50141, Italy
4 Maternal and Child Health Department, Del Ponte Hospital, A.O. Di Circolo Fondazione Macchi, Via Del Ponte, 19, Varese, 21100, Italy
5 Department of Pediatrics, Pediatric and Neonatal intensive Care Unit, Azienda Ospedaliera Universitaria Integrata, Oiazzale Stefani, 1, Verona, 37126, Italy
6 Division of Neonatology, Neonatal Intensive Care Unit, Di Venere Hospital, Bari, Via Ospedale di Venere 150, Bari, 70012, Italy
7 Department of Maternal Fetal and Neonatal Medicine, C. Arrigo Children’s Hospital, Via Santa Caterina da Siena, 30, Alessandria, 15121, Italy
8 Division of Neonatology, S. Giovanni Calibita Hospital Fatebenefratelli, Piazza Fatebenefratelli 1, 00186, Rome, Italy
9 Division of Neonatology, Neonatal Intensive Care Unit, Ospedali Riuniti, Via degli Aviatori, 1, Foggia, 71122, Italy
10 Neonatal Intensive Care Unit, Ospedale Regionale, Via L. Böhler, 5, Bolzano, 39100, Italy
11 Department of Mother and Infant Science, Neonatal Intensive Care Unit, Fondazione IRCCS ‘Ca’ Granda’Ospedale Maggiore Policlinico, Via Commenda, 12, Milan, 20122, Italy
12 Maternal and Pediatrics Department, Maggiore Hospital, Largo Nigrisoli, 2, Bologna, 40100, Italy
13 Department of Neonatology Obstetrics and Neuroscience, G. Gaslini Children’s University Hospital, Via Gerolamo Gaslini, 5, Genoa, 16148, Italy
14 Department of Pediatrics, Azienda Ospedaliera of Padua, Viale Giustiniani, 2, Padua, 35100, Italy
15 Division of Neonatology, Catholic University of Rome, Largo Agostino Gemelli 8, Rome, 00168, Italy
16 Division of Neonatology, Careggi University Hospital, University of Florence School of Medicine, Viale Morgagni, 85, Florence, 50141, Italy
Trials 2013, 14:67 doi:10.1186/1745-6215-14-67
Published: 8 March 2013Abstract
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
