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

Primary Purpose

Infections on, Severe Burn Patients

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Crucial
Sondalis HP
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections on focused on measuring infections

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Pellegrin-Unites des brules
  • Hôpital Saint Luc - Service des brûlés
  • Hôpital Edouard Herriot
  • Hopital Hotel Dieu-Service des brules
  • Hopital Saint Antoine- Service des Brules

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I

II

Arm Description

Total enteral tube feeding

Total enteral tube feeding

Outcomes

Primary Outcome Measures

Number of infections and number of multiple organ failure

Secondary Outcome Measures

digestive tolerance and healing

Full Information

First Posted
November 16, 2007
Last Updated
November 18, 2013
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT00561210
Brief Title
Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
Official Title
Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections on, Severe Burn Patients
Keywords
infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Total enteral tube feeding
Arm Title
II
Arm Type
Active Comparator
Arm Description
Total enteral tube feeding
Intervention Type
Dietary Supplement
Intervention Name(s)
Crucial
Intervention Description
Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sondalis HP
Intervention Description
Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
Primary Outcome Measure Information:
Title
Number of infections and number of multiple organ failure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
digestive tolerance and healing
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecile Chambrier
Organizational Affiliation
Hopital Edouard Herriot - Lyon
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Pellegrin-Unites des brules
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Saint Luc - Service des brûlés
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hopital Hotel Dieu-Service des brules
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint Antoine- Service des Brules
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France

12. IPD Sharing Statement

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

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