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Open Access Highly Accessed Study protocol

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

Daniele Trevisanuto12*, Francesco Cavallin3, Veronica Mardegan1, Nguyen Ngoc Loi4, Nguyen Viet Tien4, Tran Dieu Linh4, Tran Dinh Chien5, Nicoletta Doglioni1, Lino Chiandetti1 and Luciano Moccia25

Author Affiliations

1 Department of Women and Children Health, University of Padua, Via Giustiniani, 3, Azienda Ospedaliera di Padova, Padova 35128, Italy

2 Amici della Neonatologia Trentina, Trento, Italy

3 Independent statistician, Padova, Italy

4 Department of Neonatal Intensive Care, National Hospital of Obstetrics and Gynecology, Ha Noi, Vietnam

5 Breath of Life Program - East Meets West Foundation, Oakland, CA, USA

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

Published: 15 July 2014

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/design

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).

Keywords:
Laryngeal mask; Resuscitation; Positive pressure ventilation; Newborn infant