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Open Access Study protocol

LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial

Daniele Trevisanuto, Francesco Cavallin, Veronica Mardegan, Nguyen Ngoc Loi, Nguyen Viet Tien, Tran Dieu Linh, Tran Dinh Chien, Nicoletta Doglioni, Lino Chiandetti and Luciano Moccia

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Trials 2014, 15:285  doi:10.1186/1745-6215-15-285

Published: 15 July 2014

Abstract (provisional)

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). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: 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.

Trial registration: ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013).

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.