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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 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.

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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

FieldValue
Enrollment Target 272 participants
Start Date 2007-12
Est. Completion 2009-04
Phase Phase 3

What the Registry Record Tells You About NCT00609180

The ClinicalTrials.gov registry entry for NCT00609180 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00609180 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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