Tolerance of a Calorically Dense Enteral Nutrition Formula

June 29, 2017 updated by: Nestlé
This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OUHSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with established enteral access receiving standard tube feeding formula in the ICU

Description

Inclusion Criteria:

  • Adult aged > 18 years
  • Admitted to Medical ICU with expected admission of ≥ 3 days
  • Established enteral access
  • Having obtained his/her or legal representative's informed consent.

Exclusion Criteria:

  • Pregnant or lactating
  • Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
  • Lack of enteral access
  • Parenteral nutrition
  • Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.)
  • Subject who in the Investigator's assessment cannot be expected to comply with study protocol
  • Currently participating in another conflicting clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
enterally fed adults
Adults subjects with a condition for which a calorically dense enteral formula is appropriate, with established enteral access, anticipated to require enteral tube feeding for at least 3 days.
Other: Enteral Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily percentage of caloric nutritional goal met
Time Frame: First 3 days in the ICU
First 3 days in the ICU

Secondary Outcome Measures

Outcome Measure
Time Frame
Daily percentage of protein goal met
Time Frame: First 5 days in the ICU
First 5 days in the ICU
Adverse events and serious adverse events
Time Frame: First 5 days in the ICU
First 5 days in the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Karen Allen, MD, Oklahoma University Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

March 11, 2017

Study Completion (Actual)

March 11, 2017

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 15.08.US.HCN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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