Tolerance of a Calorically Dense Enteral Nutrition Formula

NCT02806427 | Completed

• 1 other identifier: 15.08.US.HCN
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Enteral Feeding

Outcome Measures

Primary Outcomes (1)

• Daily percentage of caloric nutritional goal met

  First 3 days in the ICU

Secondary Outcomes (2)

• Daily percentage of protein goal met

  First 5 days in the ICU

• Adverse events and serious adverse events

  First 5 days in the ICU

Study Arms (1)

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

Interventions

Enteral Formula OTHER

enterally fed adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

OUHSC

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

• Karen Allen, MD

  Oklahoma University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: June 30, 2016
• Primary Completion: March 11, 2017
• Study Completion: March 11, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)