Enteral Formula Tolerance in Pediatric Patients

Not Applicable

Completed

• Conditions: Enteral Nutrition
• Interventions: Other: Enteral Formula

• Registration Number: NCT02779335
• Lead Sponsor: Société des Produits Nestlé (SPN)

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 Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-18
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enteral formula tube feeding	Enteral Formula	Enteral fed children, ages 1-13, with establish enteral feeding access

Primary Outcome Measures

Name	Time	Method
Daily percentage of caloric nutritional goal met	9 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Center for GI and Nutrition; 🇺🇸 Hollywood, Florida, United States