Enteral Nutrition
Conditions
Keywords
tube-fed, Formula Tolerance, Pediatric Patients
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.
Interventions
OTHEREnteral Formula
pediatric subjects will be fed a standard pediatric enteral formula tube feeding
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 13 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily percentage of caloric nutritional goal met | 9 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily assessment of gastrointestinal tolerance - Flatulence | 9 days | Daily assessment of presence of flatulence |
| Daily assessment of gastrointestinal tolerance - Abdominal pain | 9 days | Daily assessment of abdominal pain |
| Frequency and nature of adverse events | 9 days | — |
| Daily assessment of gastrointestinal tolerance- Vomit | 9 days | Daily assessment of frequency of vomit |
| Daily assessment of gastrointestinal tolerance- Stool frequency | 9 days | Daily assessment of number of stool |
| Daily percentage of protein goal met | 9 days | — |
| Daily assessment of gastrointestinal tolerance - stool consistency | 9 days | Daily assessment of stool consistency (liquid, formed, soft) |
Countries
United States
Outcome results
None listed