Enteral Feeding Study of Formula Containing Fish Oil in Critical Care Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421941
Recruitment Status : Terminated (Unable to meet enrollment goal)
First Posted : January 15, 2007
Last Update Posted : November 1, 2013
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the clinical applicability of an enteral tube feeding formula containing fish oil and prebiotics in a critical care population.

Condition or disease Intervention/treatment Phase
Trauma Tube Feeding Procedure: Tube feeding Not Applicable

Detailed Description:

In terms of nutrition support in the acute care setting, it is generally accepted that

  1. earlier is better
  2. enteral is superior to parenteral
  3. the quality of nutrients appears more important than quantity
  4. select populations will show additional benefit from specific nutrient supplementation.

The current study is designed to evaluate the tolerance of an enteral formula in trauma and surgery patients, as demonstrated by achieving and maintaining enteral feeding goal, gastrointestinal tolerance and inflammatory markers.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Use of a High-protein Enteral Formula Containing Prebiotics and Fish Oil in Critical Care
Study Start Date : January 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care
Drug Information available for: Fish oil

Primary Outcome Measures :
  1. Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day

Secondary Outcome Measures :
  1. Gastrointestinal tolerance
  2. Time to advance to full feed
  3. Inflammatory markers
  4. Infection

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 - 70 years old
  • New ICU admit
  • Enteral tube feeding anticipated for at least 7 days
  • Informed consent

Exclusion Criteria:

  • Enteral tube feeding immediately prior to admit
  • Parenteral feeding
  • Medical condition that preclude receiving tube feeding or formula
  • Determined by PI to be inappropriate
  • Participating in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421941

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Principal Investigator: Robert Martindale, MD, PhD Oregon Health and Science University

Responsible Party: Nestlé Identifier: NCT00421941     History of Changes
Other Study ID Numbers: 06.06.US.HCN
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by Nestlé:
enteral feeding
critical care
fish oil