Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-Based Formula (RAP)

Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-based Formula

A retrospective chart review to assess feeding tolerance in adults who had been switched from an intact protein formula to a peptide-based formula due to feeding intolerance in a complex continuing care facility.

Study Overview

• Status: Completed
• Conditions: Enteral Feeding Intolerance
• Intervention / Treatment: Other: Enteral Formula

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Bruyère Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population studied retrospectively will be adult patients in a chronic care facility dependent on enteral nutrition for 90% or more of their nutritional needs and meeting the inclusion/ exclusion criteria.

Description

Inclusion Criteria:

• > 18 years of age on admission to facility
• Prescribed enteral nutrition with the goal to provide at least 90% of estimated daily calorie and protein requirements for ≥ 2 weeks prior to switch
• Received enteral nutrition with an intact protein formula for a minimum of three days 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
• Receiving a peptide-based formula formula for ≥ 2 weeks
• Have documentation of an assessment of feeding tolerance following the switch
• Formulas received must be indicated for use in adults.

Exclusion Criteria:

• Abdominal surgery (within past 30 days prior to switch)
• Having any infection, including upper respiratory, viral, gastroenteritis,wound infections, c difficile, at time of switch
• Having documented cow's milk protein allergy at time of switch
• Medical records lacking information on rationale for switch to a peptide-based formula and/or response to change (positive, neutral or negative).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enteral tube fed adults; Enteral formula	Other: Enteral Formula; Enteral feeding with a peptide-based formula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding tolerance - Gastric residuals	no change, tolerance improved, tolerance worsened	Up to 30 days after formula switch
Feeding tolerance - gagging/retching	no change, tolerance improved, tolerance worsened	Up to 30 days after formula switch
Feeding tolerance - abdominal distension/gas	no change, tolerance improved, tolerance worsened	Up to 30 days after formula switch
Feeding tolerance - vomiting	no change, tolerance improved, tolerance worsened	Up to 30 days after formula switch
Feeding tolerance - stool consistency issues	too hard, too loose	Up to 30 days after formula switch
Volume of formula consumed in a day vs. goal	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 after formula switch
Tube feeding interruptions	Number of tube feeding interruptions	Up to 30 days after formula switch

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Measured body weight	Prior to and up to 30 days following formula switch.
Medication use	Documented medication use	Prior to and up to 30 days following formula switch.
Caloric intake	Measured daily calorie intake	Up to 30 days after formula switch
Protein intake	Measured daily protein intake	Up to 30 days after formula switch

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Jean Chouinard, MD, St Vincent's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): October 2, 2018
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 16.06.US.HCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No