NCT03017664

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

January 10, 2017

Last Update Submit

January 23, 2020

Conditions

Critically Ill Children

Outcome Measures

Primary Outcomes (1)

  • Enteral formula volume

    Daily total formula volume (mL) delivered

    5 days

Other Outcomes (6)

  • Protein modular

    5 days

  • Enteral feeding interruptions

    5 days

  • Diarrhea

    5 days

  • +3 more other outcomes

Study Arms (2)

RFG

Retrospective review of enteral feeding in pediatric ICU patients for up to 5 days

Other: Retrospective review of enteral tube feeding formula

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

Interventions

Peptide-based enteral formulaOTHER

Peptide-based, higher protein and higher calorie enteral formula

PFG
Retrospective review of enteral tube feeding formulaOTHER

Enteral formula tube feeding will be retrospectively reviewed

RFG

Eligibility Criteria

Age1 Year - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 1-13 years with enteral feeding access

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Chicago, Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Study Officials

  • Krysmaru B AraujoTorres, MD

    Société des Produits Nestlé (SPN)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 11, 2017

Study Start

January 15, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)