Effect of Early Enteral Tube Feeding Nutrition With an Im... | NCT00561210

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

NCT00561210

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 19, 2013Estimated

Enrollment

57Actual

Phase

Phase 4

Conditions

Infections on
Severe Burn Patients

Interventions

Crucial
Sondalis HP

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

Nov 19, 2007

First Posted Date

Nov 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2013

Last Update Posted Date

Nov 19, 2013Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental	Total enteral tube feeding	Dietary Supplement: Crucial
II	Active Comparator	Total enteral tube feeding	Dietary Supplement: Sondalis HP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Crucial	Dietary Supplement	Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.	I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of infections and number of multiple organ failure		6 months

Secondary Outcomes

Measure	Description	Time Frame
digestive tolerance and healing		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cecile Chambrier	Hopital Edouard Herriot - Lyon	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Pellegrin-Unites des brules		Bordeaux		33076	France
Hôpital Saint Luc - Service des brûlés

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided