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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: Completed Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT01242462 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Difference in peak inspiratory pressure (PIP) and peak end expiratory pressure (PEEP) (average delta pressure) during two time periods--time period on conventional synchronized intermittent ventilation (SIMV) and time period on mid-frequency ventilation, randomly assigned.
Interventions
- PROCEDURE Conventional Pressure Controlled SIMV
- OTHER Mid-frequency Ventilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01242462 record still lists
NCT01242462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Conventional Pressure Controlled SIMV is the first listed.
NCT01242462 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01242462's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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