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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 is a Phase 3 study that has completed, run by McMaster University. The registered enrollment target is 1,011 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00433212
The ClinicalTrials.gov registry entry for NCT00433212 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,011 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McMaster University, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which nCPAP is the first listed.
NCT00433212 reports 0 study locations.
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.
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