NCT02779335
Completed
Not Applicable
Enteral Formula Tolerance in Pediatric Patients
Société des Produits Nestlé (SPN)1 site in 1 country22 target enrollmentMay 2016
ConditionsEnteral Nutrition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Enteral Nutrition
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Daily percentage of caloric nutritional goal met
- Status
- Completed
- Last Updated
- 9 years ago
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.
Investigators
Eligibility Criteria
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)
Study Sites (1)
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