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.
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Full eligibility criteria for NCT02912065
Ages eligible for Study
13 Months to 17 Years
Genders eligible for Study
Accepts Healthy Volunteers
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).
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.
All locations for NCT02912065
United States (1)
Childrens Center for Gastroenterology
Hollywood, Florida, United States, 33021
View full eligibility
Tris trial is registered with FDA with number: NCT02912065. The sponsor of the trial is Nestlé and it is looking for 13 volunteers for the current phase.
Official trial title: Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay: A Retrospective Assessment
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