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NCT01156480 · ClinicalTrials.gov registry record · NA
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
A NA study, sponsored by Endeavor Health.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT01156480: Clinical Trial NA study, sponsored by Endeavor Health.
NCT01156480 is a NA study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01156480, a NA study, was terminated before completion, sponsored by Endeavor Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The investigators will follow C-reactive protein (CRP) levels as a marker of systemic inflammation for the primary outcome in this study.
Primary Outcome
C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.
Interventions
- DRUG placebo
- DRUG hydrocortisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-11 |
| Phase | NA |
Why NCT01156480 stopped before completion
NCT01156480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01156480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01156480 about?
NCT01156480 is a clinical study titled "Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants". Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded ...
What is the current status of trial NCT01156480?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2009-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01156480?
The interventions under investigation include: placebo (DRUG), hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT01156480?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01156480's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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