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NCT00599651 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)
A NA study, sponsored by University of Virginia.
- Terminated
- Registry status
- NA
- Development phase
- 380
- Enrollment target
NCT00599651 is a NA study that was terminated before completion, run by University of Virginia. The registered enrollment target is 380 participants.
The verdict
NCT00599651, a NA study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- NA
- Development phase
- 380 participants
- Enrollment target
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.
Interventions
- DEVICE Surfactant administered via Laryngeal Mask Airway (LMA)
- OTHER standard of care (nasal CPAP and supplemental oxygen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2005-06 |
| Est. Completion | 2009-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00599651
The ClinicalTrials.gov registry entry for NCT00599651 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Surfactant administered via Laryngeal Mask Airway (LMA) is the first listed.
NCT00599651 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00599651 about?
NCT00599651 is a clinical study titled "Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)". 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 ...
What is the current status of trial NCT00599651?
This trial is currently terminated. It is a NA study. The enrollment target is 380 participants. The study started on 2005-06. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00599651?
The interventions under investigation include: Surfactant administered via Laryngeal Mask Airway (LMA) (DEVICE), standard of care (nasal CPAP and supplemental oxygen) (OTHER).
Who is sponsoring clinical trial NCT00599651?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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