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Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017664
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.

Condition or disease Intervention/treatment
Critically Ill Children Other: Peptide-based enteral formula Other: Retrospective review of enteral tube feeding formula

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

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Improvement Project Towards Optimizing Nutrition Intervention With a Higher Protein and Calorie Pediatric Tube Feeding Formula
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
RFG
Retrospective review of enteral feeding in pediatric ICU patients for up to 5 days
Other: Retrospective review of enteral tube feeding formula
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
Other: Peptide-based enteral formula
Peptide-based, higher protein and higher calorie enteral formula




Primary Outcome Measures :
  1. Enteral formula volume [ Time Frame: 5 days ]
    Daily total formula volume (mL) delivered


Other Outcome Measures:
  1. Protein modular [ Time Frame: 5 days ]
    yes/no; if yes, dose (g/mL) and schedule

  2. Enteral feeding interruptions [ Time Frame: 5 days ]
    yes/no; if yes, reason for interruption

  3. Diarrhea [ Time Frame: 5 days ]
    yes/no; if yes, frequency in 24 hour period

  4. Vomiting [ Time Frame: 5 days ]
    yes/no; if yes, frequency in 24 hour period

  5. Elevated gastric residuals [ Time Frame: 5 days ]
    yes/no; if yes, amount (mL) in 24 hour period

  6. Abdominal distention/pain [ Time Frame: 5 days ]
    yes/no



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Ages Eligible for Study:   1 Year to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged 1-13 years with enteral feeding access
Criteria

Inclusion Criteria:

  • Children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017664


Locations
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United States, Illinois
The University of Chicago, Comer Children's Hospital
Chicago, Illinois, United States, 60637
United States, Tennessee
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
Nestlé
Investigators
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Study Director: Krysmaru B AraujoTorres, MD Nestlé
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03017664    
Other Study ID Numbers: 16.04.US.HCN
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes