Enteral Formula Tolerance in Pediatric Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enteral Formula Tolerance in Pediatric Patients

Conditions
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Enteral Nutrition

Intervention / Treatment
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* Other: Enteral Formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Enteral formula tube feeding<br>Enteral fed children, ages 1-13, with establish enteral feeding access | Other: Enteral Formula<br>* pediatric subjects will be fed a standard pediatric enteral formula tube feeding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily percentage of caloric nutritional goal met |  | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily percentage of protein goal met |  | 9 days | 
| Daily assessment of gastrointestinal tolerance - stool consistency | Daily assessment of stool consistency (liquid, formed, soft) | 9 days | 
| Daily assessment of gastrointestinal tolerance- Stool frequency | Daily assessment of number of stool | 9 days | 
| Daily assessment of gastrointestinal tolerance- Vomit | Daily assessment of frequency of vomit | 9 days | 
| Daily assessment of gastrointestinal tolerance - Flatulence | Daily assessment of presence of flatulence | 9 days | 
| Daily assessment of gastrointestinal tolerance - Abdominal pain | Daily assessment of abdominal pain | 9 days | 
| Frequency and nature of adverse events |  | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tube-fed, Formula Tolerance, Pediatric Patients