NCT00421941

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

January 12, 2007

Last Update Submit

October 31, 2013

Conditions

TraumaTube Feeding

Keywords

enteral feedingcritical carefish oilsurgical

Outcome Measures

Primary Outcomes (1)

  • Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day

Secondary Outcomes (4)

  • Gastrointestinal tolerance

  • Time to advance to full feed

  • Inflammatory markers

  • Infection

Interventions

Tube feedingPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Robert Martindale, MD, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 15, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

US(1)