Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
November 18, 2013 updated by: Société des Produits Nestlé (SPN)
Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 4
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
-
-
-
Bordeaux, France, 33076
- CHU Pellegrin-Unites des brules
-
Lyon, France, 69437
- Hôpital Edouard Herriot
-
Lyon, France, 69009
- Hôpital Saint Luc - Service des brûlés
-
Nantes, France, 44093
- Hopital Hotel Dieu-Service des brules
-
Paris Cedex 12, France, 75571
- Hopital Saint Antoine- Service des Brules
-
-
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
15 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: I
Total enteral tube feeding
|
Treatment between minimum 14 days and maximum 6 months.
Apports depend on method of CURRERI.
|
|
Active Comparator: II
Total enteral tube feeding
|
Treatment between minimum 14 days and maximum 6 months.
Apports depend on method of CURRERI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of infections and number of multiple organ failure
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
digestive tolerance and healing
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Cecile Chambrier, Hopital Edouard Herriot - Lyon
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
November 1, 2003
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
November 16, 2007
First Submitted That Met QC Criteria
November 19, 2007
First Posted (Estimate)
November 20, 2007
Study Record Updates
Last Update Posted (Estimate)
November 19, 2013
Last Update Submitted That Met QC Criteria
November 18, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCNF 0501
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.