NCT01173237

Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 30 Minutes – 8 Hours
• Healthy volunteers: Not accepted

Summary

With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
PROCEDURE	Use tracheal intubation for surfactant therapy	Surfactant endotracheal administration after tracheal intubation
PROCEDURE	Use of Proseal laryngeal mask airway for surfactant therapy	Surfactant use by proseal laryngeal mask airway

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-03-01
• Completion: 2013-07-01
• First posted: 2010-08-02
• Last updated: 2011-06-28

Locations

2 sites across 1 country: Brazil