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

Infections on Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561210
• Other study ID #: NCNF 0501
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2007
• Last updated: November 18, 2013
• Start date: November 2003
• Est. completion date: March 2010

Study information

• Verified date: November 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Infections on
• Severe Burn Patients

Intervention

Dietary Supplement:
• Crucial
Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
• Sondalis HP
Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.

Locations

Country	Name	City	State
France	CHU Pellegrin-Unites des brules	Bordeaux
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Saint Luc - Service des brûlés	Lyon
France	Hopital Hotel Dieu-Service des brules	Nantes
France	Hopital Saint Antoine- Service des Brules	Paris Cedex 12

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infections and number of multiple organ failure		6 months	Yes
Secondary	digestive tolerance and healing		6 months	Yes