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
• 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

• Trauma
• Tube Feeding

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