|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03048409 |
|
Date of registration:
|
07/02/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-Based Formula
RAP |
|
Scientific title:
|
Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-based Formula |
|
Date of first enrolment:
|
July 24, 2017 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03048409 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Jean Chouinard, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St. Vincent's Hospital-Manhattan |
| | |
|
Key inclusion & exclusion 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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Enteral Feeding Intolerance
|
|
Intervention(s)
|
|
Other: Enteral Formula
|
|
Primary Outcome(s)
|
|
Volume of formula consumed in a day vs. goal
[Time Frame: Up to 30 days after formula switch]
|
|
Feeding tolerance - gagging/retching
[Time Frame: Up to 30 days after formula switch]
|
|
Tube feeding interruptions
[Time Frame: Up to 30 days after formula switch]
|
|
Feeding tolerance - stool consistency issues
[Time Frame: Up to 30 days after formula switch]
|
|
Feeding tolerance - abdominal distension/gas
[Time Frame: Up to 30 days after formula switch]
|
|
Feeding tolerance - Gastric residuals
[Time Frame: Up to 30 days after formula switch]
|
|
Feeding tolerance - vomiting
[Time Frame: Up to 30 days after formula switch]
|
|
Secondary Outcome(s)
|
|
Protein intake
[Time Frame: Up to 30 days after formula switch]
|
|
Caloric intake
[Time Frame: Up to 30 days after formula switch]
|
|
Medication use
[Time Frame: Prior to and up to 30 days following formula switch.]
|
|
Weight
[Time Frame: Prior to and up to 30 days following formula switch.]
|
|
Secondary ID(s)
|
|
16.06.US.HCN
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|