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

This study has been terminated.
(Unable to meet enrollment goal)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421941
First Posted: January 15, 2007
Last Update Posted: November 1, 2013
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.
Information provided by (Responsible Party):
Nestlé
  Purpose
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 Intervention
Trauma Tube Feeding Procedure: Tube feeding

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nestlé:

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

Secondary Outcome Measures:
  • Gastrointestinal tolerance
  • Time to advance to full feed
  • Inflammatory markers
  • Infection

Estimated Enrollment: 50
Study Start Date: January 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00421941


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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00421941     History of Changes
Other Study ID Numbers: 06.06.US.HCN
First Submitted: January 12, 2007
First Posted: January 15, 2007
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by Nestlé:
enteral feeding
critical care
fish oil
surgical