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NCT00433212 · ClinicalTrials.gov registry record · Phase 3
Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)
A Phase 3 study, sponsored by McMaster University.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,011
- Enrollment target
NCT00433212: Completed Phase 3 study, sponsored by McMaster University.
NCT00433212 is a Phase 3 study that has completed, run by McMaster University. The registered enrollment target is 1,011 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00433212, a Phase 3 study, has completed, sponsored by McMaster University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,011 participants
- Enrollment target
Study Summary
The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine. Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?
Interventions
- DEVICE nCPAP
- DEVICE NIPPV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,011 participants |
| Start Date | 2007-04 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT00433212 record still lists
NCT00433212 is an interventional study that assigns participants to a tested intervention. Its 1,011 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 2 interventions - of which nCPAP is the first listed.
NCT00433212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00433212 about?
NCT00433212 is a clinical study titled "Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)". The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year ...
What is the current status of trial NCT00433212?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,011 participants. The study started on 2007-04. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00433212?
The interventions under investigation include: nCPAP (DEVICE), NIPPV (DEVICE).
Who is sponsoring clinical trial NCT00433212?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00433212's enrollment target sits among peer trials
1,011 295th of 2000 higher than 1,706 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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