Clinical trial NCT03048409: Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-Based Formula
Official title: Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-based Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enteral Feeding Intolerance
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Feeding tolerance - Gastric residuals
timeFrame: Up to 30 days after formula switch
measure: Feeding tolerance - gagging/retching
timeFrame: Up to 30 days after formula switch
measure: Feeding tolerance - abdominal distension/gas
timeFrame: Up to 30 days after formula switch
measure: Feeding tolerance - vomiting
timeFrame: Up to 30 days after formula switch
measure: Feeding tolerance - stool consistency issues
timeFrame: Up to 30 days after formula switch
measure: Volume of formula consumed in a day vs. goal
timeFrame: Up to 30 days after formula switch
measure: Tube feeding interruptions
timeFrame: Up to 30 days after formula switch
Secondary outcomes:
measure: Weight
timeFrame: Prior to and up to 30 days following formula switch.
measure: Medication use
timeFrame: Prior to and up to 30 days following formula switch.
measure: Caloric intake
timeFrame: Up to 30 days after formula switch
measure: Protein intake
timeFrame: Up to 30 days after formula switch
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Bruyere Research Institute
state: Ontario
Study officials:
affiliation: St Vincent's Hospital
name: Jean Chouinard, MD
role: PRINCIPAL_INVESTIGATOR
References: