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Clinical Trials/NCT02779335
NCT02779335
Completed
Not Applicable

Enteral Formula Tolerance in Pediatric Patients

Société des Produits Nestlé (SPN)1 site in 1 country22 target enrollmentMay 2016

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Société des Produits Nestlé (SPN)
Responsible Party
Sponsor

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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