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Completed

NCT Number: NCT02912065

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

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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Key information

Conditions

Developmental Disabilities Feeding Disorder Feeding and Eating Disorders Mental Disorders Neurodevelopmental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Center for Gastroenterology

Hollywood, Florida, 33021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Intake of target feeding volume

    Time frame: up to 30 days post formula switch

    Documentation of feeding volume after switch as "less than," "about the same as," or "more than" feeding volume achieved before switch.

  2. Feeding intolerance parameter(s) identified before switch to Peptide based formula and feeding tolerance parameter(s) improved by switch.

    Time frame: up to 30 days post formula switch

    Intolerance Parameter's: Gagging/retching, vomiting, high residuals, abdominal distention/ gas, stool consistency issues (too hard, too loose).

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2016
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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