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

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT02912065

Collaborator

(none)

Enrollment

Location

1.9

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Developmental Disabilities Feeding Disorder

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

13 participants

Time Perspective:

Retrospective

Official Title:

Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay: A Retrospective Assessment

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Outcome Measures

Primary Outcome Measures

Feeding tolerance after switching to Peptide based formula [up to 30 days post formula switch]
Categorized as no change, tolerance improved, tolerance worsened.

Secondary Outcome Measures

Intake of target feeding volume [up to 30 days post formula switch]
Documentation of feeding volume after switch as "less than," "about the same as," or "more than" feeding volume achieved before switch.
Feeding intolerance parameter(s) identified before switch to Peptide based formula and feeding tolerance parameter(s) improved by switch. [up to 30 days post formula switch]
Intolerance Parameter's: Gagging/retching, vomiting, high residuals, abdominal distention/ gas, stool consistency issues (too hard, too loose).

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Months to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens Center for Gastroenterology	Hollywood	Florida	United States	33021

Sponsors and Collaborators

Nestlé

Investigators

Principal Investigator: Gerard Minor, PA-C, Childrens Center for Gastroenterology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT02912065

Other Study ID Numbers:

14.08.US.HCN

First Posted:

Sep 23, 2016

Last Update Posted:

Oct 5, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Developmental Disabilities

Feeding and Eating Disorders

Study Results

No Results Posted as of Oct 5, 2016