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NCT00883948 · ClinicalTrials.gov registry record · Phase 3

Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study)

A Phase 3 study of Respiratory Distress Syndrome, Adult, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Completed
Registry status
Phase 3
Development phase
1,000
Enrollment target
20
Study locations

NCT00883948 is a Phase 3 study of Respiratory Distress Syndrome, Adult that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 1,000 participants, above the 184-participant average among 7 other Respiratory Distress Syndrome, Adult trials with a reported enrollment target (443% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT00883948, a Phase 3 study of Respiratory Distress Syndrome, Adult, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

COMPLETED
Registry status
Phase 3
Development phase
1,000 participants
Enrollment target
20
Study locations

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 remain 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.

Conditions Studied

Respiratory Distress Syndrome, Adult

Interventions

  • BEHAVIORAL Minimal (Trophic) Feeding
  • BEHAVIORAL Full Feeding

Study Locations (20)

Louisiana

  • Baton Rouge General Hospital-Blue Bonnet - Baton Rouge
  • Baton Rouge General Hospital-Midcity - Baton Rouge
  • Earl K. Long Medical Center - Baton Rouge
  • Our Lady of the Lake Regional Medical Center - Baton Rouge
  • Medical Center of Louisiana - New Orleans
  • Ochsner Clinic Foundation - New Orleans
  • Tulane University Health Sciences Center - New Orleans

Colorado

  • Centura St. Anthony Central Hospital - Denver
  • Denver Health Medical Center - Denver
  • Rose Medical Center - Denver
  • University of Colorado Health Sciences Center - Denver

Maryland

  • Johns Hopkins Bayview Medical Center - Baltimore
  • Johns Hopkins Hospital - Baltimore
  • Union Memorial Hospital - Baltimore
  • University of Maryland Shock Trauma Center - Baltimore

California

  • University of San Francisco-Fresno Medical Center - Fresno
  • University of California, Davis Medical Center - Sacramento
  • University of California, San Francisco (UCSF)-Moffitt Hospital - San Francisco

District of Columbia

  • Washington Hospital Center - Washington D.C.

Massachusetts

  • Baystate Medical Center - Springfield

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2007-12
Est. Completion 2011-05
Phase Phase 3

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

501 total trials

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What the Registry Record Tells You About NCT00883948

The ClinicalTrials.gov registry entry for NCT00883948 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 184-participant average among 7 other Respiratory Distress Syndrome, Adult trials with a reported enrollment target (443% higher). 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 1 condition, with Respiratory Distress Syndrome, Adult appearing as the primary indexed condition, and to 2 interventions - of which Minimal (Trophic) Feeding is the first listed.

NCT00883948 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Louisiana, Colorado, Maryland.

Frequently Asked Questions

What is clinical trial NCT00883948 about?

NCT00883948 is a clinical study titled "Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN 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 NCT00883948?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2007-12. Estimated completion is 2011-05.

What conditions does trial NCT00883948 study?

This clinical trial studies the following conditions: Respiratory Distress Syndrome, Adult.

What interventions are being tested in trial NCT00883948?

The interventions under investigation include: Minimal (Trophic) Feeding (BEHAVIORAL), Full Feeding (BEHAVIORAL).

Who is sponsoring clinical trial NCT00883948?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00883948 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.