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Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study)
NCT00883948 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2007-12 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00883948
The ClinicalTrials.gov registry entry for NCT00883948 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 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 381 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00883948 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Louisiana, Colorado, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00883948?
The interventions under investigation include: Minimal (Trophic) Feeding (BEHAVIORAL), Full Feeding (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00883948?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 381 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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