Tolerance of a Calorically Dense Enteral Nutrition Formula

Enteral Feeding Clinical Trial

Official title:

Tolerance of a Calorically Dense Enteral Nutrition Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806427
• Other study ID #: 15.08.US.HCN
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: June 29, 2017
• Start date: June 30, 2016
• Est. completion date: March 11, 2017

Study information

• Verified date: June 2017
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 11, 2017
• Est. primary completion date: March 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enteral Feeding

Intervention

Other:
• Enteral Formula

Locations

Country	Name	City	State
United States	OUHSC	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily percentage of caloric nutritional goal met		First 3 days in the ICU
Secondary	Daily percentage of protein goal met		First 5 days in the ICU
Secondary	Adverse events and serious adverse events		First 5 days in the ICU