Enteral Formula Tolerance in Pediatric Patients

NCT ID: NCT02779335

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Enteral Nutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Enteral formula tube feeding

Enteral fed children, ages 1-13, with establish enteral feeding access

Group Type OTHER

Enteral Formula

Intervention Type OTHER

pediatric subjects will be fed a standard pediatric enteral formula tube feeding

Interventions

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Enteral Formula

pediatric subjects will be fed a standard pediatric enteral formula tube feeding

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerard Minor, MMS, PA-C

Role: PRINCIPAL_INVESTIGATOR

Children's Center for GI and Nutrition

Locations

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Children's Center for GI and Nutrition

Hollywood, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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15.09.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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