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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:
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
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

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
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 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
Study First Received: November 16, 2007
Last Updated: November 18, 2013

Keywords provided by Nestlé:
infections

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2017