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NCT00005777 · ClinicalTrials.gov registry record · Phase 3
Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Terminated
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
NCT00005777: Clinical Trial Phase 3 study, sponsored by NICHD Neonatal Research Network.
NCT00005777 is a Phase 3 study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005777, a Phase 3 study, was terminated before completion, sponsored by NICHD Neonatal Research Network.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
Study Summary
This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ventilation (PCO(2) target \<48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The infants' neurodevelopment was evaluated at 18-22 months corrected age.
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- PROCEDURE Minimal mechanical ventilation management
- PROCEDURE Routine mechanical ventilation management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 1998-02 |
| Est. Completion | 2002-09 |
| Phase | Phase 3 |
Why NCT00005777 stopped before completion
NCT00005777 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00005777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005777 about?
NCT00005777 is a clinical study titled "Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)". This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ve...
What is the current status of trial NCT00005777?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 1998-02. Estimated completion is 2002-09.
What interventions are being tested in trial NCT00005777?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Minimal mechanical ventilation management (PROCEDURE), Routine mechanical ventilation management (PROCEDURE).
Who is sponsoring clinical trial NCT00005777?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005777's enrollment target sits among peer trials
220 1318th of 2000 higher than 672 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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