- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02779335
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
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
-
-
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
|
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
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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