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.
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
  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).
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  NCT01440868.
authors.affiliation: Department of Surgical and Medical Critical Care, Section of Neonatology, Careggi University Hospital, Viale Morgagni 85, Florence 50141, Italy. cdani@unifi.it
authors.forename: Carlo
authors.initials: C
authors.lastname: Dani
authors.forename: Gianluca
authors.initials: G
authors.lastname: Lista
authors.forename: Simone
authors.initials: S
authors.lastname: Pratesi
authors.forename: Luca
authors.initials: L
authors.lastname: Boni
authors.forename: Massimo
authors.initials: M
authors.lastname: Agosti
authors.forename: Paolo
authors.initials: P
authors.lastname: Biban
authors.forename: Antonio
authors.initials: A
authors.lastname: Del Vecchio
authors.forename: Diego
authors.initials: D
authors.lastname: Gazzolo
authors.forename: Camilla
authors.initials: C
authors.lastname: Gizzi
authors.forename: Rosario
authors.initials: R
authors.lastname: Magaldi
authors.forename: Hubert
authors.initials: H
authors.lastname: Messner
authors.forename: Fabio
authors.initials: F
authors.lastname: Mosca
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Sandri
authors.forename: Fabio
authors.initials: F
authors.lastname: Scopesi
authors.forename: Daniele
authors.initials: D
authors.lastname: Trevisanuto
authors.forename: Giovanni
authors.initials: G
authors.lastname: Vento
mesh_terms: D001997:Bronchopulmonary Dysplasia / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D002985:Clinical Protocols; D045422:Continuous Positive Airway Pressure; D003696:Delivery Rooms; D005652:Functional Residual Capacity; D005865:Gestational Age; D006801:Humans; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D007558:Italy; D008168:Lung / Q000503:physiopathology*; D011175:Positive-Pressure Respiration / Q000009:adverse effects / Q000379:methods*; D011663:Pulmonary Surfactants / Q000627:therapeutic use; D012107:Research Design; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D011663:Pulmonary Surfactants