Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients

NCT ID: NCT00561210

Last Updated: 2013-11-19

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2010-03-31

Brief Summary

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Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .

Detailed Description

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Conditions

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Infections on Severe Burn Patients

Keywords

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infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Total enteral tube feeding

Group Type EXPERIMENTAL

Crucial

Intervention Type DIETARY_SUPPLEMENT

Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

II

Total enteral tube feeding

Group Type ACTIVE_COMPARATOR

Sondalis HP

Intervention Type DIETARY_SUPPLEMENT

Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

Interventions

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Crucial

Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

Intervention Type DIETARY_SUPPLEMENT

Sondalis HP

Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Thermic burn from 20% to 80%
* 15 \< age \< 70 years
* written informed consent

Exclusion Criteria

* diabetes mellitus
* corticoid or immuno-suppressive therapy
* HIV
* evolutive cancers
* pregnancy
* abdominal lesion
* hepatic or renal failure
Minimum Eligible Age

15 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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Cecile Chambrier

Role: STUDY_CHAIR

Hopital Edouard Herriot - Lyon

Locations

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CHU Pellegrin-Unites des brules

Bordeaux, , France

Site Status

Hôpital Saint Luc - Service des brûlés

Lyon, , France

Site Status

Hôpital Edouard Herriot

Lyon, , France

Site Status

Hopital Hotel Dieu-Service des brules

Nantes, , France

Site Status

Hopital Saint Antoine- Service des Brules

Paris, , France

Site Status

Countries

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France

Other Identifiers

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NCNF 0501

Identifier Type: -

Identifier Source: org_study_id