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

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

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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