Enteral Feeding Study of Formula Containing Fish Oil in C... | NCT00421941

Studies
Enteral Feeding Study of Formula Containing Fish Oil in Critical Care Setting

NCT00421941

Sponsor

Société des Produits Nestlé (SPN)

Status

Terminated

Last Update Posted

Nov 1, 2013Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Trauma
Tube Feeding

Interventions

Tube feeding

Countries

United States

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

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to meet enrollment goal

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jan 12, 2007

First Submission Date that Met QC Criteria

Jan 12, 2007

First Posted Date

Jan 15, 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

Oct 31, 2013

Last Update Posted Date

Nov 1, 2013Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the clinical applicability of an enteral tube feeding formula containing fish oil and prebiotics in a critical care population.

Detailed Description

In terms of nutrition support in the acute care setting, it is generally accepted that

earlier is better
enteral is superior to parenteral
the quality of nutrients appears more important than quantity
select populations will show additional benefit from specific nutrient supplementation.

The current study is designed to evaluate the tolerance of an enteral formula in trauma and surgery patients, as demonstrated by achieving and maintaining enteral feeding goal, gastrointestinal tolerance and inflammatory markers.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Tube feeding	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day

Secondary Outcomes

Measure	Description	Time Frame
Gastrointestinal tolerance
Time to advance to full feed
Inflammatory markers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 - 70 years old
New ICU admit
Enteral tube feeding anticipated for at least 7 days
Informed consent

Exclusion Criteria:

Enteral tube feeding immediately prior to admit
Parenteral feeding
Medical condition that preclude receiving tube feeding or formula
Determined by PI to be inappropriate
Participating in another clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Martindale, MD, PhD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided