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

Developmental Disabilities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912065
• Other study ID #: 14.08.US.HCN
• Status: Completed
• Phase: N/A
• First received: September 21, 2016
• Last updated: October 4, 2016
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Months to 17 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Developmental Disabilities
• Feeding Disorder

Locations

Country	Name	City	State
United States	Childrens Center for Gastroenterology	Hollywood	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feeding tolerance after switching to Peptide based formula	Categorized as no change, tolerance improved, tolerance worsened.	up to 30 days post formula switch	No
Secondary	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	No
Secondary	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	No