title: LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ≥34 weeks' gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists.Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation.
  
  
  METHODS
  This will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ≥34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA SupremeTM, LMA Company, UK - intervention group) or with a face mask (control group).
  
  
  METHODS
  Proportion of newborns needing endotracheal intubation.
  
  
  RESULTS
  Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013).
authors.affiliation: Department of Women and Children Health, University of Padua, Via Giustiniani, 3, Azienda Ospedaliera di Padova, Padova 35128, Italy. trevo@pediatria.unipd.it.
authors.forename: Daniele
authors.initials: D
authors.lastname: Trevisanuto
authors.forename: Francesco
authors.initials: F
authors.lastname: Cavallin
authors.forename: Veronica
authors.initials: V
authors.lastname: Mardegan
authors.forename: Nguyen Ngoc
authors.initials: NN
authors.lastname: Loi
authors.forename: Nguyen Viet
authors.initials: NV
authors.lastname: Tien
authors.forename: Tran Dieu
authors.initials: TD
authors.lastname: Linh
authors.forename: Tran Dinh
authors.initials: TD
authors.lastname: Chien
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Doglioni
authors.forename: Lino
authors.initials: L
authors.lastname: Chiandetti
authors.forename: Luciano
authors.initials: L
authors.lastname: Moccia
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D007231:Infant, Newborn; D017214:Laryngeal Masks; D017063:Outcome Assessment, Health Care; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D012151:Resuscitation