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NCT01467076 · ClinicalTrials.gov registry record · Phase 2
Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
A Phase 2 study, sponsored by NICHD Neonatal Research Network.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01467076: Clinical Trial Phase 2 study, sponsored by NICHD Neonatal Research Network.
NCT01467076 is a Phase 2 study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01467076, a Phase 2 study, was terminated before completion, sponsored by NICHD Neonatal Research Network.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate the feasibility and safety of prolonged IPGE1 administration and determination of optimal dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale randomized controlled trial will be planned.
Primary Outcome
The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (\>20%) protocol violations.
Interventions
- DRUG Aerosolized Normal Saline
- DRUG Inhaled PGE1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
Why NCT01467076 stopped before completion
NCT01467076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Aerosolized Normal Saline is the first listed.
NCT01467076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01467076 about?
NCT01467076 is a clinical study titled "Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)". This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate the feasibility and safe...
What is the current status of trial NCT01467076?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2011-11. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01467076?
The interventions under investigation include: Aerosolized Normal Saline (DRUG), Inhaled PGE1 (DRUG).
Who is sponsoring clinical trial NCT01467076?
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 NCT01467076's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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