Enteral Formula Tolerance of Standard Tube Feedings
Completed
- Conditions
- Enteral Feeding
- Interventions
- Other: enteral formula
- Registration Number
- NCT02312271
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description enterally fed adults enteral formula adult subjects with established enteral access receiving standard tube feeding formula
- Primary Outcome Measures
Name Time Method Daily percentage of caloric nutritional goal met 21 days
- Secondary Outcome Measures
Name Time Method GI tolerance 21 days Adverse events and serious adverse events 21 days Daily percentage of protein goal met 21 days
Trial Locations
- Locations (3)
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Bruyere Research Institute
🇨🇦Ottawa, Ontario, Canada
University of Arkansas
🇺🇸Little Rock, Arkansas, United States