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Clinical Trials/NCT02312271
NCT02312271
Completed
Not Applicable

Enteral Formula Tolerance of Standard Tube Feedings

Société des Produits Nestlé (SPN)3 sites in 2 countries102 target enrollmentDecember 2014
ConditionsEnteral Feeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Enteral Feeding
Sponsor
Société des Produits Nestlé (SPN)
Enrollment
102
Locations
3
Primary Endpoint
Daily percentage of caloric nutritional goal met
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
April 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Société des Produits Nestlé (SPN)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥18 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 21 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)
  • Currently participating in another conflicting clinical study that would interfere with anticipated endpoints
  • Judged to be at risk for poor compliance to the study protocol.
  • Lack of informed consent.

Outcomes

Primary Outcomes

Daily percentage of caloric nutritional goal met

Time Frame: 21 days

Secondary Outcomes

  • GI tolerance(21 days)
  • Adverse events and serious adverse events(21 days)
  • Daily percentage of protein goal met(21 days)

Study Sites (3)

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