- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03017664
Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding
January 23, 2020 updated by: Nestlé
An Improvement Project Towards Optimizing Nutrition Intervention With a Higher Protein and Calorie Pediatric Tube Feeding Formula
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.
The primary aim of this quality improvement project is to better meet protein needs of ICU critically ill children
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago, Comer Children's Hospital
-
-
Tennessee
-
Memphis, Tennessee, United States, 38103
- Le Bonheur Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 13 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children aged 1-13 years with enteral feeding access
Description
Inclusion Criteria:
- Children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RFG
Retrospective review of enteral feeding in pediatric ICU patients for up to 5 days
|
Enteral formula tube feeding will be retrospectively reviewed
|
PFG
Pediatric ICU population to be fed a peptide-based enteral formula with higher protein and higher calories for up to 5 days
|
Peptide-based, higher protein and higher calorie enteral formula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enteral formula volume
Time Frame: 5 days
|
Daily total formula volume (mL) delivered
|
5 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein modular
Time Frame: 5 days
|
yes/no; if yes, dose (g/mL) and schedule
|
5 days
|
Enteral feeding interruptions
Time Frame: 5 days
|
yes/no; if yes, reason for interruption
|
5 days
|
Diarrhea
Time Frame: 5 days
|
yes/no; if yes, frequency in 24 hour period
|
5 days
|
Vomiting
Time Frame: 5 days
|
yes/no; if yes, frequency in 24 hour period
|
5 days
|
Elevated gastric residuals
Time Frame: 5 days
|
yes/no; if yes, amount (mL) in 24 hour period
|
5 days
|
Abdominal distention/pain
Time Frame: 5 days
|
yes/no
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Krysmaru B AraujoTorres, MD, Nestlé
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2018
Primary Completion (ACTUAL)
June 30, 2019
Study Completion (ACTUAL)
December 31, 2019
Study Registration Dates
First Submitted
January 10, 2017
First Submitted That Met QC Criteria
January 10, 2017
First Posted (ESTIMATE)
January 11, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 23, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16.04.US.HCN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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