A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation

Abstract

BACKGROUND: 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. METHODS: In this phase 3, open‐label, superiority trial in Uganda, we 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. RESULTS: Complete follow‐up data were available for 99.2% of the neonates. A primary outcome event occurred in 154 of 563 neonates (27.4%) in the LMA group and 144 of 591 (24.4%) in the face‐mask group (adjusted relative risk, 1.16; 95% confidence interval [CI], 0.90 to 1.51; P = 0.26). 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 (adjusted relative risk, 1.21; 95% CI, 0.90 to 1.63), 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 (adjusted relative risk, 1.27; 95% CI, 0.84 to 1.93). 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. CONCLUSIONS: 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. (Funded by the Research Council of Norway and the Center for Intervention Science in Maternal and Child Health; NeoSupra ClinicalTrials.gov number, NCT03133572.).