drugset / Trial / NCT01116921

Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

NCT01116921 ↗

Completed 103 enrolled University of Minnesota
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.

Timeline

Start
2011-02
Primary completion
2015-04
Completion
2015-04

Outcome

Met primary endpoint

paper Surfactant administration through an LMA (n = 50) significantly decreased the rate of intubation and mechanical ventilation compared with controls (n = 53) PMID 29174079 ↗

paper 38% vs 64%, respectively, OR 0.30 (95% CI 0.13, 0.70), P = .006 PMID 29174079 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Poractant alfa Other / unclassified 2.5 unknown Other