NCT02312271

Brief Summary

This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

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

December 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

December 5, 2014

Last Update Submit

May 29, 2017

Conditions

Enteral Feeding

Outcome Measures

Primary Outcomes (1)

  • Daily percentage of caloric nutritional goal met

    21 days

Secondary Outcomes (3)

  • Daily percentage of protein goal met

    21 days

  • GI tolerance

    21 days

  • Adverse events and serious adverse events

    21 days

Study Arms (1)

enterally fed adults

adult subjects with established enteral access receiving standard tube feeding formula

Other: enteral formula

Interventions

enteral formulaOTHER

standard tube feeding formulas

enterally fed adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with established enteral access receiving standard tube feeding formula

You may qualify if:

  • ≥18 years of age
  • Currently tolerating enteral feeding
  • Has enteral access
  • Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 21 days
  • Having obtained his/her and/or his/her legal representative's informed consent.

You may not qualify if:

  • Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
  • Lack of enteral access
  • Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
  • Currently participating in another conflicting clinical study that would interfere with anticipated endpoints
  • Judged to be at risk for poor compliance to the study protocol.
  • Lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Arkansas

Little Rock, Arkansas, United States

Location

Vanderbilt University

Nashville, Tennessee, United States

Location

Bruyere Research Institute

Ottawa, Ontario, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 9, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

US(2)CA(1)