Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay: A Retrospective Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Feeding tolerance after switching to Peptide based formula
Study Overview
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.
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
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 13 Months to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Feeding tolerance after switching to Peptide based formula
Time Frame: up to 30 days post formula switch
Categorized as no change, tolerance improved, tolerance worsened.
Secondary Outcomes
- 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)