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

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ClinicalTrials.gov Identifier: NCT00561210
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .

Condition or disease Intervention/treatment Phase
Infections on Severe Burn Patients Dietary Supplement: Crucial Dietary Supplement: Sondalis HP Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
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
Study Start Date : November 2003
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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.




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

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


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
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

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

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

Keywords provided by Nestlé:
infections

Additional relevant MeSH terms:
Burns
Wounds and Injuries