NCT02779335CompletedNot Applicable
Enteral Formula Tolerance in Pediatric Patients
Société des Produits Nestlé (SPN)2 sites in 1 country22 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Daily percentage of caloric nutritional goal met
Study Overview
Brief Summary
The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.
Detailed Description
In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1 - 13 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 9 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)
- •Judged to be at risk for poor compliance to the study protocol
- •Lack of informed consent
- •Currently participating in another conflicting clinical trial
Outcomes
Primary Outcomes
Daily percentage of caloric nutritional goal met
Time Frame: 9 days
Secondary Outcomes
- Daily assessment of gastrointestinal tolerance - stool consistency(9 days)
- Daily assessment of gastrointestinal tolerance - Abdominal pain(9 days)
- Daily assessment of gastrointestinal tolerance- Stool frequency(9 days)
- Frequency and nature of adverse events(9 days)
- Daily percentage of protein goal met(9 days)
- Daily assessment of gastrointestinal tolerance- Vomit(9 days)
- Daily assessment of gastrointestinal tolerance - Flatulence(9 days)
Investigators
Study Sites (2)
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