Clinical Trial: Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial
Brief 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.
Detailed Summary:
Sponsor: Federal University of Minas Gerais
Current Primary Outcome: Fraction of inspired oxygen [ Time Frame: three hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Hormonal evaluation of pain [ Time Frame: three hours ]
- Proseal laryngeal mask surfactant treatment failure [ Time Frame: Six hours ]
- Rate of respiratory distress syndrome complications [ Time Frame: 28 days ]
Original Secondary Outcome: Same as current
Information By: Federal University of Minas Gerais
Dates:
Date Received: July 26, 2010
Date Started: July 2011
Date Completion: July 2013
Last Updated: June 27, 2011
Last Verified: July 2010
