NCT01116921

Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 36 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	Nasal continuous positive airway pressure (nCPAP)	nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
DEVICE	Laryngeal Mask Airway (LMA) to deliver surfactant	Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
DRUG	Surfactants, Pulmonary	Curosurf®, Chiesi USA, Inc., Cary, NC

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2010-05-05
• Last updated: 2017-02-27
• Results posted: 2017-02-27

Locations

7 sites across 1 country: United States