Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay

NCT ID: NCT02912065

Last Updated: 2016-10-05

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

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-03-31

Brief Summary

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A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed.

Detailed Description

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Medical records of pediatric patients with enteral feeding intolerance on standard polymeric formulas that were switched to a peptide based formula will be retrospectively analyzed. Data will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of intolerance, and the use of medications to control gastrointestinal symptoms.

Conditions

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Developmental Disabilities Feeding Disorder

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 13 months to \< 18 years of age on admission to facility
* Required enteral nutrition to meet 90% or more of their energy needs prior to switch to a Peptide based formula
* Received enteral nutrition with an intact protein formula for a minimum of two weeks prior to a switch to a Peptide based formula
* Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a Peptide based formula
* Have documentation of an assessment of feeding tolerance following the switch to a Peptide based formula
* Formulas received must be indicated for use in children or adults (not infant formulas).

Exclusion Criteria

* Recent abdominal surgery, change in tube position/placement (within past 30 days)
* Cow's milk protein allergy
* Any current infections including upper respiratory, viral, gastroenteritis, wound infection.
Minimum Eligible Age

13 Months

Maximum Eligible Age

17 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, PA-C

Role: PRINCIPAL_INVESTIGATOR

Childrens Center for Gastroenterology

Locations

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Childrens Center for Gastroenterology

Hollywood, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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14.08.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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