Enteral Feeding Study of Formula Containing Fish Oil in Critical Care Setting
October 31, 2013 updated by: Nestlé
Use of a High-protein Enteral Formula Containing Prebiotics and Fish Oil in Critical Care
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.
Study Overview
Detailed Description
In terms of nutrition support in the acute care setting, it is generally accepted that
- earlier is better
- enteral is superior to parenteral
- the quality of nutrients appears more important than quantity
- 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
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Infection
|
|
Inflammatory markers
|
|
Gastrointestinal tolerance
|
|
Time to advance to full feed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Martindale, MD, PhD, Oregon Health and Science University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
January 12, 2007
First Submitted That Met QC Criteria
January 12, 2007
First Posted (Estimate)
January 15, 2007
Study Record Updates
Last Update Posted (Estimate)
November 1, 2013
Last Update Submitted That Met QC Criteria
October 31, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 06.06.US.HCN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.