Tolerance of a Calorically Dense Enteral Nutrition Formula

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02806427
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enteral Feeding	Other: Enteral Formula

Study Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Tolerance of a Calorically Dense Enteral Nutrition Formula
• Actual Study Start Date: Jun 30, 2016
• Actual Primary Completion Date: Mar 11, 2017
• Actual Study Completion Date: Mar 11, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Daily percentage of caloric nutritional goal met [First 3 days in the ICU]

Secondary Outcome Measures

1. Daily percentage of protein goal met [First 5 days in the ICU]

2. Adverse events and serious adverse events [First 5 days in the ICU]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OUHSC	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• Nestlé

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT02806427
• Other Study ID Numbers: 15.08.US.HCN
• First Posted: Jun 20, 2016
• Last Update Posted: Jul 2, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Jul 2, 2017