Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02912065
Enrollment
13
Registered
2016-09-23
Start date
2015-01-31
Completion date
2015-03-31
Last updated
2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Disabilities, Feeding Disorder

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.

Interventions

None listed

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Months to 17 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Feeding tolerance after switching to Peptide based formulaup to 30 days post formula switchCategorized as no change, tolerance improved, tolerance worsened.

Secondary

MeasureTime frameDescription
Intake of target feeding volumeup to 30 days post formula switchDocumentation 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 switchIntolerance Parameter's: Gagging/retching, vomiting, high residuals, abdominal distention/ gas, stool consistency issues (too hard, too loose).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026