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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00561210
First received: November 16, 2007
Last updated: November 18, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • digestive tolerance and healing [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561210

Locations
France
CHU Pellegrin-Unites des brules
Bordeaux, France, 33076
Hôpital Edouard Herriot
Lyon, France, 69437
Hôpital Saint Luc - Service des brûlés
Lyon, France, 69009
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

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00561210     History of Changes
Other Study ID Numbers: NCNF 0501
Study First Received: November 16, 2007
Last Updated: November 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nestlé:
infections

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 23, 2014