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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 is a Phase 3 study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 61 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005774
The ClinicalTrials.gov registry entry for NCT00005774 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Early surfactant is the first listed.
NCT00005774 reports 0 study locations.
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.
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