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

Phase 4

Completed

• Conditions: Infections on; Severe Burn Patients
• Interventions: Dietary Supplement: Crucial; Dietary Supplement: Sondalis HP

• Registration Number: NCT00561210
• Lead Sponsor: Société des Produits Nestlé (SPN)

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Crucial	Total enteral tube feeding
II	Sondalis HP	Total enteral tube feeding

Primary Outcome Measures

Name	Time	Method
Number of infections and number of multiple organ failure	6 months

Secondary Outcome Measures

Name	Time	Method
digestive tolerance and healing	6 months

Trial Locations

Locations (5)

CHU Pellegrin-Unites des brules; 🇫🇷 Bordeaux, France

Hopital Hotel Dieu-Service des brules; 🇫🇷 Nantes, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital Saint Luc - Service des brûlés; 🇫🇷 Lyon, France

Hopital Saint Antoine- Service des Brules; 🇫🇷 Paris Cedex 12, France