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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: Completed Phase 4 study, sponsored by University of Southern California.

NCT00486850 is a Phase 4 study that has completed, run by University of Southern California. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 110 participants
Start Date 2006-10
Est. Completion 2009-01
Phase Phase 4
University of Southern California

617 total trials

What the finished NCT00486850 record still lists

NCT00486850 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 1 intervention - of which Extubation to Nasal IPPV is the first listed.

NCT00486850 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00486850's enrollment target sits among peer trials

110 727th of 2000 higher than 1,264 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00486850, the US trial registry maintained by the National Library of Medicine. NCT00486850 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.