Enteral Formula Tolerance in Pediatric Patients

October 20, 2016 updated by: Nestlé
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Hollywood, Florida, United States, 33021
        • Children's Center for GI and Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily percentage of caloric nutritional goal met
Time Frame: 9 days
9 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Gerard Minor, MMS, PA-C, Children's Center for GI and Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (ESTIMATE)

May 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15.09.US.HCN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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