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Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway

NCT01173237 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-06-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • Yerkes P Silva, PhD · Federal University of Minas Gerais

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
8 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-03-31
Completion
2013-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01173237 on ClinicalTrials.gov