Enteral Formula Tolerance of Standard Tube Feedings

Enteral Feeding Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312271
• Other study ID #: 14.01.US.HCN
• Status: Completed
• Phase: N/A
• First received: December 5, 2014
• Last updated: May 29, 2017
• Start date: December 2014
• Est. completion date: April 2017

Study information

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

Clinical Trial Summary

This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age

• Currently tolerating enteral feeding

• Has enteral access

• Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 21 days

• Having obtained his/her and/or his/her legal representative's informed consent.

Exclusion Criteria:

• Condition which contraindicates enteral feeding (i.e. intestinal obstruction)

• Lack of enteral access

• Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)

• Currently participating in another conflicting clinical study that would interfere with anticipated endpoints

• Judged to be at risk for poor compliance to the study protocol.

• Lack of informed consent.

Related Conditions & MeSH terms

• Enteral Feeding

Intervention

Other:
• enteral formula
standard tube feeding formulas

Locations

Country	Name	City	State
Canada	Bruyere Research Institute	Ottawa	Ontario
United States	University of Arkansas	Little Rock	Arkansas
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily percentage of caloric nutritional goal met		21 days
Secondary	Daily percentage of protein goal met		21 days
Secondary	GI tolerance		21 days
Secondary	Adverse events and serious adverse events		21 days