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LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial
Daniele Trevisanuto1, Francesco Cavallin, Veronica Mardegan
1Department of Women and Children Health, University of Padua, Via Giustiniani, 3, Azienda Ospedaliera di Padova, Padova 35128, Italy. trevo@pediatria.unipd.it.
Trials
|July 17, 2014
Summary
Laryngeal mask airways may be more effective than face masks for neonatal resuscitation, reducing the need for endotracheal intubation in newborns. This study compares these methods in a clinical setting with midwives, nurses, and pediatricians.
Area of Science:
- Neonatal resuscitation
- Pediatric critical care
- Airway management
Background:
- Effective assisted ventilation is crucial for newborn resuscitation.
- Laryngeal mask airways (LMAs) are an alternative to face masks or endotracheal intubation for neonatal ventilation.
- Previous studies suggest LMAs reduce endotracheal intubation rates, but had methodological concerns and anesthesiologist-led interventions.
Purpose of the Study:
- To assess the effectiveness of laryngeal mask airways compared to face masks in preventing endotracheal intubation during neonatal resuscitation.
- To evaluate LMA effectiveness in a setting managed by midwives, nurses, and pediatricians.
Main Methods:
- An open, prospective, randomized, single-center clinical trial.
- 142 newborns weighing >1,500 g or born ≥34 weeks gestation requiring positive pressure ventilation were randomized.
- Intervention group received ventilation with a Laryngeal Mask Airway (LMA Supreme™), control group with a face mask.
Main Results:
- The primary outcome is the proportion of newborns requiring endotracheal intubation.
- Secondary outcomes include Apgar score at 5 minutes, time to first breath, cry onset, resuscitation duration, and death or hypoxic-ischemic encephalopathy within 7 days.
Conclusions:
- This study aims to provide evidence on the efficacy of LMAs versus face masks in neonatal resuscitation performed by non-anesthesiologists.
- Findings will inform best practices for airway management in delivery rooms.
