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

NCT02912065 | Completed

• 1 other identifier: 14.08.US.HCN
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Disabilities; Feeding Disorder

Outcome Measures

Primary Outcomes (1)

• Feeding tolerance after switching to Peptide based formula

  Categorized as no change, tolerance improved, tolerance worsened.

  up to 30 days post formula switch

Secondary Outcomes (2)

• Intake of target feeding volume

  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.

  up to 30 days post formula switch

Eligibility Criteria

• Age: 13 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Childrens Center for Gastroenterology

Hollywood, Florida, 33021, United States

Location

MeSH Terms

Conditions

Developmental Disabilities; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Minor, PA-C

  Childrens Center for Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 5, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)