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NCT01954056 · ClinicalTrials.gov registry record · Phase 3
Hydrocortisone for Term Hypotension
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT01954056: Completed Phase 3 study, sponsored by NICHD Neonatal Research Network.
NCT01954056 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954056, a Phase 3 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Primary Outcome
This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
Interventions
- DRUG Placebo
- DRUG Hydrocortisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-06-19 |
| Est. Completion | 2018-03-20 |
| Phase | Phase 3 |
What the finished NCT01954056 record still lists
NCT01954056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01954056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01954056 about?
NCT01954056 is a clinical study titled "Hydrocortisone for Term Hypotension". This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope ...
What is the current status of trial NCT01954056?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2014-06-19. Estimated completion is 2018-03-20.
What interventions are being tested in trial NCT01954056?
The interventions under investigation include: Placebo (DRUG), Hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT01954056?
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 NCT01954056's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 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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