Abstract
BackgroundThe 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/designThis 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 registrationClinicalTrials.gov identifier: NCT01963936 (October 11, 2013).
Highlights
The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation
Aim The primary aim of this study will be to assess the effectiveness of laryngeal mask airway (LMA) over face mask (FM) ventilation in preventing the need for endotracheal intubation at birth
Inclusion criteria Inborn infants satisfying the following inclusion criteria will be eligible to participate in the study: 1. gestational age ≥34 weeks 2. expected birth weight >1,500 g [9,10] 3. need for positive pressure ventilation (PPV) at birth; the need for PPV will be determined by the presence of apnoea or gasping, or heart rate
Summary
The ability to maintain a patent airway and provide effective positive pressure ventilation (PPV) is the main objective of neonatal resuscitation [1,2] This is currently achieved with the use of a face mask (FM) or an endotracheal tube (ETT). Both these devices have major limitations from a strictly anatomical point of view and require adequate operator skills. A 2005 Cochrane review concluded that there was no evidence to evaluate the safety or efficacy for the use of LMA versus FM ventilation in the resuscitation of newborn infants [11] It suggested that a well-designed randomized controlled trial (RCT) comparing these two airway adjuncts was warranted [11]. It has not yet been shown in a well-conducted RCT whether or not LMA is more effective than FM in resuscitation of newborn infants
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
