NCT02312271
Completed
Not Applicable
Enteral Formula Tolerance of Standard Tube Feedings
Société des Produits Nestlé (SPN)3 sites in 2 countries102 target enrollmentDecember 2014
ConditionsEnteral Feeding
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Enteral Feeding
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 102
- Locations
- 3
- Primary Endpoint
- Daily percentage of caloric nutritional goal met
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Daily percentage of caloric nutritional goal met
Time Frame: 21 days
Secondary Outcomes
- GI tolerance(21 days)
- Adverse events and serious adverse events(21 days)
- Daily percentage of protein goal met(21 days)
Study Sites (3)
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