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

NCT ID: NCT00421941

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Trauma Tube Feeding

Keywords

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enteral feeding critical care fish oil surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tube feeding

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Martindale, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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06.06.US.HCN

Identifier Type: -

Identifier Source: org_study_id