Respiratory Distress Syndrome, Newborn Clinical Trial
Official title:
Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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