title: Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial.
abstract: OBJECTIVE
  To assess the effectiveness of supreme laryngeal mask airway (SLMA) over face mask ventilation for preventing need for endotracheal intubation at birth.
  
  
  METHODS
  We report a prospective, randomized, parallel 1:1, unblinded, controlled trial. After a short-term educational intervention on SLMA use, infants ≥34-week gestation and/or expected birth weight ≥1500 g requiring positive pressure ventilation (PPV) at birth were randomized to resuscitation by SLMA or face mask. The primary outcome was the success rate of the resuscitation devices (SLMA or face mask) defined as the achievement of an effective PPV preventing the need for endotracheal intubation.
  
  
  RESULTS
  We enrolled 142 patients (71 in SLMA and 71 in face mask group, respectively). Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation (91.5% vs 78.9%; P = .03). Apgar score at 5 minutes was significantly higher in SLMA than in face mask group (P = .02). Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group (P = .02). No complications related to the procedure occurred.
  
  
  CONCLUSIONS
  In newborns with gestational age ≥34 weeks and/or expected birth weight ≥1500 g needing PPV at birth, the SLMA is more effective than face mask to prevent endotracheal intubation. The SLMA is effective in clinical practice after a short-term educational intervention.
  
  
  BACKGROUND
  Registered with ClinicalTrials.gov: NCT01963936.
authors.affiliation: Department of Women and Children Health, University of Padua, Azienda Ospedaliera di Padova, Padova, Italy; Amici della Neonatologia Trentina, Trento, Italy. Electronic address: trevo@pediatria.unipd.it.
authors.forename: Daniele
authors.initials: D
authors.lastname: Trevisanuto
authors.affiliation: Independent Statistician, Padova, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cavallin
authors.affiliation: Department of Neonatal Intensive Care, National Hospital of Obstetrics and Gynecology, Ha Noi, Viet Nam.
authors.forename: Loi Ngoc
authors.initials: LN
authors.lastname: Nguyen
authors.affiliation: Department of Neonatal Intensive Care, National Hospital of Obstetrics and Gynecology, Ha Noi, Viet Nam.
authors.forename: Tien Viet
authors.initials: TV
authors.lastname: Nguyen
authors.affiliation: Department of Neonatal Intensive Care, National Hospital of Obstetrics and Gynecology, Ha Noi, Viet Nam.
authors.forename: Linh Dieu
authors.initials: LD
authors.lastname: Tran
authors.affiliation: Breath of Life Program - East Meets West Foundation, Oakland, CA.
authors.forename: Chien Dinh
authors.initials: CD
authors.lastname: Tran
authors.affiliation: Department of Women and Children Health, University of Padua, Azienda Ospedaliera di Padova, Padova, Italy.
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Doglioni
authors.affiliation: Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Micaglio
authors.affiliation: Amici della Neonatologia Trentina, Trento, Italy; Breath of Life Program - East Meets West Foundation, Oakland, CA.
authors.forename: Luciano
authors.initials: L
authors.lastname: Moccia
mesh_terms: D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007442:Intubation, Intratracheal / Q000295:instrumentation*; D017214:Laryngeal Masks; D008297:Male; D008397:Masks; D011175:Positive-Pressure Respiration / Q000295:instrumentation*; D011446:Prospective Studies; D012151:Resuscitation / Q000295:instrumentation / Q000379:methods*; D014744:Vietnam