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EDEN-Omega

Sub-Study Submission Instructions

Sub-study and Ancillary Study Proposals

Process and Format

Revised: 15 Sept 2008

For all proposals submitted to the Natural History and Pathogenesis Committees Definitions

  • “Sub-studies” are investigator-initiated studies that utilize previously collected data or samples from ARDSnet clinical trials. The studies may be related to the clinical issues addressed in the original trial, but the existing data and samples may also be used to address other questions.

  • “Ancillary studies” are investigator-initiated studies that involve an extension of the main goals of an ARDSnet trial, and usually require collection of additional data or samples. Additional funds, independent of the ARDSnet contracts, are generally required for ancillary studies.

EDEN - Omega

Study status: Open
Study dates: Nov 2006 —

Prospective, Randomized Trial of initial trophic enteral feeding followed by advancement to full-calorie enteral feeding vs. early advancement to full-calorie enteral feeding. This trial will be run simultaneously with a trial of omega-3 fatty acid, gamma-linolenic acid, and anti-oxidant supplementation vs. a comparator.

ClinicalTrials.Gov Registration Page

These trials will test the safety and efficacy of these treatments in the management of patients with ALI or ARDS.

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