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

This study has been terminated.
(Unable to meet enrollment goal)
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00421941
First received: January 12, 2007
Last updated: October 31, 2013
Last verified: October 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00421941     History of Changes
Other Study ID Numbers: 06.06.US.HCN
Study First Received: January 12, 2007
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 09, 2014