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NCT01242462 · ClinicalTrials.gov registry record · Phase 1

Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial

A Phase 1 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT01242462 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 12 participants.

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The verdict

NCT01242462, a Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm infants. Despite improved survival of extremely premature infants with RDS, complications related to mechanical ventilation still occur. This trial will attempt to maintain adequate gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak inspiratory pressure in infants with respiratory distress requiring mechanical ventilation. A cross over design will be used to test the hypothesis whether mid-frequency ventilation in preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory pressure requirement when compared to conventional mechanical ventilation.

Interventions

  • PROCEDURE Conventional Pressure Controlled SIMV
  • OTHER Mid-frequency Ventilation

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2011-10
Est. Completion 2013-05
Phase Phase 1

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT01242462

The ClinicalTrials.gov registry entry for NCT01242462 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Conventional Pressure Controlled SIMV is the first listed.

NCT01242462 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01242462 about?

NCT01242462 is a clinical study titled "Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial". Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm infants. Despite improved survival of extremely premature infants with RDS, complications related to mechanical ventilation still occur. This trial will attempt to maintain adequate gas exchange at a rapid rate, s...

What is the current status of trial NCT01242462?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2011-10. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01242462?

The interventions under investigation include: Conventional Pressure Controlled SIMV (PROCEDURE), Mid-frequency Ventilation (OTHER).

Who is sponsoring clinical trial NCT01242462?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.