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

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Childrens Center for Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The population studied retrospectively will be pediatric patients with developmental delays dependent on enteral nutrition for 90% or more of their nutritional needs and meeting the inclusion/ exclusion criteria.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding tolerance after switching to Peptide based formula	Categorized as no change, tolerance improved, tolerance worsened.	up to 30 days post formula switch

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Gerard Minor, PA-C, Childrens Center for Gastroenterology

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Feeding and Eating Disorders; Developmental Disabilities
• Other Study ID Numbers: 14.08.US.HCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be presented in manuscript