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

NCT03048409 | Completed

• 1 other identifier: 16.06.US.HCN
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enteral Feeding Intolerance

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Weight

  Prior to and up to 30 days following formula switch.

• Medication use

  Prior to and up to 30 days following formula switch.

• Caloric intake

  Up to 30 days after formula switch

• Protein intake

  Up to 30 days after formula switch

Study Arms (1)

Enteral tube fed adults

Enteral formula

Other: Enteral Formula

Interventions

Enteral Formula OTHER

Enteral feeding with a peptide-based formula.

Enteral tube fed adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \> 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Bruyere Research Institute

Ottawa, Ontario, Canada

Location

Study Officials

• Jean Chouinard, MD

  St Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: July 24, 2017
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)