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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014