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NCT00609180 · ClinicalTrials.gov registry record · Phase 3
Early Versus Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN-Omega Study)
A Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- Phase 3
- Development phase
- 272
- Enrollment target
NCT00609180: Clinical Trial Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00609180 is a Phase 3 study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 272 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00609180, a Phase 3 study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 272 participants
- Enrollment target
Study Summary
Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS often includes the use of a breathing machine, or ventilator, until the person is able to breathe without assistance. Initiating proper nutrition through a feeding tube early in a person's hospital stay may help to improve recovery, but the optimal timing, composition, and amount of feeding treatments are unknown. This study will evaluate whether early or delayed full-calorie feeding through a feeding tube is more effective in reducing recovery time and increasing survival rates in people with ALI/ARDS. The study will also determine whether supplementing the feedings with omega-3 fatty acids and antioxidants benefits people with ALI/ARDS.
Interventions
- DIETARY_SUPPLEMENT Placebo
- BEHAVIORAL Minimal (Trophic) Feeding
- BEHAVIORAL Full Feeding
- DIETARY_SUPPLEMENT Omega-3 Fatty Acids and Antioxidant Supplements
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
Why NCT00609180 stopped before completion
NCT00609180 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00609180 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00609180 about?
NCT00609180 is a clinical study titled "Early Versus Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN-Omega Study)". Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS often includes the use ...
What is the current status of trial NCT00609180?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 272 participants. The study started on 2007-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00609180?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Minimal (Trophic) Feeding (BEHAVIORAL), Full Feeding (BEHAVIORAL), Omega-3 Fatty Acids and Antioxidant Supplements (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00609180?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00609180's enrollment target sits among peer trials
272 1214th of 2000 higher than 785 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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