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

This study is currently recruiting participants.

Verified by Nestle Clinical Nutrition, November 2007

Sponsored by:	Nestle Clinical Nutrition
Information provided by:	Nestle Clinical Nutrition
ClinicalTrials.gov Identifier:	NCT00561210

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
Severe Burn Patients	Dietary Supplement: Crucial Dietary Supplement: Sondalis HP	Phase IV

MedlinePlus related topics: Burns Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients

Further study details as provided by Nestle Clinical Nutrition:

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 ]

Estimated Enrollment:	80
Study Start Date:	November 2003
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
I: Experimental Total enteral tube feeding	Dietary Supplement: Crucial Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
II: Active Comparator 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
corticoïd 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

Contacts

Contact: Cecile CHAMBRIER, MD

33 (0)4 72 11 76 13

cecile.chambrier@chu-lyon.fr

Locations

France
Hôpital Edouard Herriot	Recruiting
Lyon, France, 69437
Contact: Marc Bertin-Maghit, MD 33 (0)4 72 11 75 92 marc.bertin-maghit@chu-lyon.fr
Principal Investigator: Marc Bertin-Maghit, MD
Hôpital Saint Luc - Service des brûlés	Terminated
Lyon, France, 69009
Hopital Saint Antoine- Service des Brules	Recruiting
Paris Cedex 12, France, 75571
Contact: Julien Pham 01.49.28.26.09
Principal Investigator: Julien Pham
CHU Pellegrin-Unites des brules	Recruiting
Bordeaux, France, 33076
Contact: Gerard Perro 05.56.79.55.31
Principal Investigator: Gerard Perro
Sub-Investigator: Alain Robert
Hopital Hotel Dieu-Service des brules	Recruiting
Nantes, France, 44093
Contact: Ronan Le Floch 02.40.08.73.04
Principal Investigator: Ronan Le Floch
Sub-Investigator: Jean Francois Arnould

Sponsors and Collaborators

Nestle Clinical Nutrition

Investigators

Study Chair:

Cecile Chambrier

Hopital Edouard Herriot Lyon

More Information

Study ID Numbers:	NCNF 0501
Study First Received:	November 16, 2007
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00561210
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Burns

ClinicalTrials.gov processed this record on January 15, 2009