Improvement Project To Optimizing Nutrition With Higher P... | NCT03017664

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

NCT03017664

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Jan 27, 2020Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Critically Ill Children

Interventions

Peptide-based enteral formula
Retrospective review of enteral tube feeding formula

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2018Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jan 10, 2017

First Submission Date that Met QC Criteria

Jan 10, 2017

First Posted Date

Jan 11, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2020

Last Update Posted Date

Jan 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Peptide-based enteral formula	Other	Peptide-based, higher protein and higher calorie enteral formula	PFG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Enteral formula volume	Daily total formula volume (mL) delivered	5 days

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Protein modular	yes/no; if yes, dose (g/mL) and schedule	5 days
Enteral feeding interruptions	yes/no; if yes, reason for interruption	5 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

13 Years

Standard Ages

Child

Study Population

Children aged 1-13 years with enteral feeding access

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Krysmaru B AraujoTorres, MD	Société des Produits Nestlé (SPN)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Chicago, Comer Children's Hospital		Chicago	Illinois	60637	United States
Le Bonheur Children's Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided