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NCT00005773 · ClinicalTrials.gov registry record · Phase 3
Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Terminated
- Registry status
- Phase 3
- Development phase
- 302
- Enrollment target
NCT00005773 is a Phase 3 study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 302 participants.
The verdict
NCT00005773, a Phase 3 study, was terminated before completion, sponsored by NICHD Neonatal Research Network.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 302 participants
- Enrollment target
Study Summary
This prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) -- temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants who were born at \>34 weeks' gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) \>15 and \<25 on any 2 measurements in a 12-hour interval. Infants were randomized to receive either early iNO or to simulated initiation of iNO (control). Infants who had an increase in OI to 25 or more were given iNO as standard therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.
Interventions
- DRUG Inhaled Nitric Oxide
- DRUG Standard iNO therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 1998-08 |
| Est. Completion | 2003-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005773
The ClinicalTrials.gov registry entry for NCT00005773 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 302 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 Inhaled Nitric Oxide is the first listed.
NCT00005773 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005773 about?
NCT00005773 is a clinical study titled "Early Inhaled Nitric Oxide for Respiratory Failure in Newborns". This prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) -- temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants who were born at \>34 weeks...
What is the current status of trial NCT00005773?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 1998-08. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00005773?
The interventions under investigation include: Inhaled Nitric Oxide (DRUG), Standard iNO therapy (DRUG).
Who is sponsoring clinical trial NCT00005773?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
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