A Randomized Trial of Laryngeal Mask Airway in Neonatal Resu
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Face-mask ventilation is the most common resuscitation method for birth asphyxia. Ventilation with a cuffless laryngeal mask airway (LMA) has potential advantages over face-mask ventilation during neonatal resuscitation in low-income countries, but whether the use of an LMA reduces mortality and morbidity among neonates with asphyxia is unknown.

In this phase 3, open-label superiority trial, researchers randomly assigned neonates who required positive-pressure ventilation to be treated by a midwife with an LMA or with face-mask ventilation. All the neonates had an estimated gestational age of at least 34 weeks, an estimated birth weight of at least 2000 g, or both. The primary outcome was a composite of death within 7 days or admission to the neonatal intensive care unit (NICU) with moderate-to-severe hypoxic–ischemic encephalopathy at day 1 to 5 during hospitalization.

Complete follow-up data were available for 99.2% of the neonates. A primary outcome event occurred in neonates (27.4%) in the LMA group and (24.4%) in the face-mask group. Death within 7 days occurred in 21.7% of the neonates in the LMA group and 18.4% of those in the face-mask group, and admission to the NICU with moderate-to-severe hypoxic–ischemic encephalopathy at day 1 to 5 during hospitalization occurred in 11.2% and 10.1%, respectively. Findings were materially unchanged in a sensitivity analysis in which neonates with missing data were counted as having had a primary outcome event in the LMA group and as not having had such an event in the face-mask group. The frequency of predefined intervention-related adverse events was similar in the two groups.

In neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic–ischemic encephalopathy.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2005333?rss=searchAndBrowse
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