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NCT00005774 · ClinicalTrials.gov registry record · Phase 3
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Terminated
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT00005774: Clinical Trial Phase 3 study, sponsored by NICHD Neonatal Research Network.
NCT00005774 is a Phase 3 study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005774, a Phase 3 study, was terminated before completion, sponsored by NICHD Neonatal Research Network.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study Summary
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
Interventions
- DRUG Early surfactant
- DRUG Standard practice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2000-05 |
| Est. Completion | 2002-07 |
| Phase | Phase 3 |
Why NCT00005774 stopped before completion
NCT00005774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Early surfactant is the first listed.
NCT00005774 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005774 about?
NCT00005774 is a clinical study titled "Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants". Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-c...
What is the current status of trial NCT00005774?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2000-05. Estimated completion is 2002-07.
What interventions are being tested in trial NCT00005774?
The interventions under investigation include: Early surfactant (DRUG), Standard practice (DRUG).
Who is sponsoring clinical trial NCT00005774?
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 NCT00005774's enrollment target sits among peer trials
61 1803rd of 2000 higher than 197 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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