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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00561210
First Posted: November 20, 2007
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  Purpose
Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .

Condition Intervention Phase
Infections on Severe Burn Patients Dietary Supplement: Crucial Dietary Supplement: Sondalis HP Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Number of infections and number of multiple organ failure [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • digestive tolerance and healing [ Time Frame: 6 months ]

Enrollment: 57
Study Start Date: November 2003
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Total enteral tube feeding
Dietary Supplement: Crucial
Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
Active Comparator: II
Total enteral tube feeding
Dietary Supplement: Sondalis HP
Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561210


Locations
France
CHU Pellegrin-Unites des brules
Bordeaux, France, 33076
Hôpital Saint Luc - Service des brûlés
Lyon, France, 69009
Hôpital Edouard Herriot
Lyon, France, 69437
Hopital Hotel Dieu-Service des brules
Nantes, France, 44093
Hopital Saint Antoine- Service des Brules
Paris Cedex 12, France, 75571
Sponsors and Collaborators
Nestlé
Investigators
Study Chair: Cecile Chambrier Hopital Edouard Herriot - Lyon
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00561210     History of Changes
Other Study ID Numbers: NCNF 0501
First Submitted: November 16, 2007
First Posted: November 20, 2007
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Nestlé:
infections

Additional relevant MeSH terms:
Burns
Wounds and Injuries