Tolerance of a Calorically Dense Enteral Nutrition Formula

NCT ID: NCT02806427

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-11

Brief Summary

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This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.

Detailed Description

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Conditions

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Enteral Feeding

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Enteral Formula

Intervention Type OTHER

Interventions

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Enteral Formula

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma University Health Sciences Center

Locations

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OUHSC

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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15.08.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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