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NCT00004500 · ClinicalTrials.gov registry record · Phase 3
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
A Phase 3 study, sponsored by Windtree Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
NCT00004500: Clinical Trial Phase 3 study, sponsored by Windtree Therapeutics.
NCT00004500 is a Phase 3 study that was terminated before completion, run by Windtree Therapeutics. The registered enrollment target is 69 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004500, a Phase 3 study, was terminated before completion, sponsored by Windtree Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
Study Summary
OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
Primary Outcome
A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.
Interventions
- OTHER Standard Care
- DRUG Lucinactant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2000-03 |
| Est. Completion | 2004-11 |
| Phase | Phase 3 |
Why NCT00004500 stopped before completion
NCT00004500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT00004500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004500 about?
NCT00004500 is a clinical study titled "Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome". OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
What is the current status of trial NCT00004500?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2000-03. Estimated completion is 2004-11.
What interventions are being tested in trial NCT00004500?
The interventions under investigation include: Standard Care (OTHER), Lucinactant (DRUG).
Who is sponsoring clinical trial NCT00004500?
This trial is sponsored by Windtree Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004500's enrollment target sits among peer trials
69 1793rd of 2000 higher than 205 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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