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NCT00421941 Clinical Trial

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

Trauma Clinical Trial

Official title:
Use of a High-protein Enteral Formula Containing Prebiotics and Fish Oil in Critical Care

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00421941
Other study ID # 06.06.US.HCN
Secondary ID
Status Terminated
Phase N/A
First received January 12, 2007
Last updated October 31, 2013
Start date January 2007
Est. completion date August 2008

Study information
Verified date October 2013
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 50
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Tube feeding

Locations
Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day
Secondary Gastrointestinal tolerance
Secondary Time to advance to full feed
Secondary Inflammatory markers
Secondary Infection
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