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Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)

NCT00599651 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2010-05-07

No results posted yet for this study

Summary

In this protocol we will conduct a randomized controlled trial where babies with respiratory distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach "failure" criteria, which is the standard criterion for surfactant administration (i.e., FiO2= 65% while receiving nasal CPAP).

The objective of this RCT is to determine if surfactant can be successfully administered by LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer babies in the LMA group would reach failure criteria.

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

DEVICE

Surfactant administered via Laryngeal Mask Airway (LMA)

Standard volume of Infasurf surfactant (3 mL/kg) will be injected in 2-4 aliquots into the proximal end of the LMA.

OTHER

standard of care (nasal CPAP and supplemental oxygen)

Standard of care will be utilized which may mean surfactant is administered

Sponsors & Collaborators

  • LMA North America

    collaborator UNKNOWN

  • ONY

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • John Kattwinkel, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • United States

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 NCT00599651 on ClinicalTrials.gov