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NCT00486850 · ClinicalTrials.gov registry record · Phase 4
Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress
A Phase 4 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
NCT00486850 is a Phase 4 study that has completed, run by University of Southern California. The registered enrollment target is 110 participants.
The verdict
NCT00486850, a Phase 4 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
Study Summary
Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory Distress Treatment Period (Planned): 7 days Objectives: To compare the impact of early extubation \[within 120 minutes of birth to Nasal Intermittent Positive Pressure Ventilation (NIPPV group) vs. Synchronized Intermittent Mandatory Ventilation (SIMV group) on the incidence of mechanical ventilation via endotracheal tube at 7 days of age in 26 to 29 + 6 weeks gestation premature infants with respiratory distress treated with intratracheal Curosurf (poractant alpha) within 60 minutes of birth. Secondary objectives include evaluation of overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age (PMA) and/or at discharge, complications, safety, and adverse events. Number of Subjects: 110
Interventions
- OTHER Extubation to Nasal IPPV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00486850
The ClinicalTrials.gov registry entry for NCT00486850 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Extubation to Nasal IPPV is the first listed.
NCT00486850 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00486850 about?
NCT00486850 is a clinical study titled "Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress". Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory Distress Treatment Period (Pla...
What is the current status of trial NCT00486850?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2006-10. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00486850?
The interventions under investigation include: Extubation to Nasal IPPV (OTHER).
Who is sponsoring clinical trial NCT00486850?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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