Review of Enteral Formulas in Children | NCT04247269

Studies
Review of Enteral Formulas in Children

NCT04247269

Sponsor

Société des Produits Nestlé (SPN)

Status

Withdrawn

Last Update Posted

Jun 9, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Enteral Feeding Intolerance
Tube Feeding
Nutrition Disorder, Child

Interventions

Enteral Tube Feeding

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Site closure due to Covid Pandemic

Expanded Access Info

Start Date

Aug 21, 2020Actual

Primary Completion Date

Jun 2, 2022Actual

Completion Date

Jun 2, 2022Actual

First Submitted Date

Jan 23, 2020

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 30, 2020Actual

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

Jun 7, 2022

Last Update Posted Date

Jun 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Retrospective review of nutrition enteral formula data documented in medical records.

Detailed Description

This is a retrospective review to assess nutrition (calorie and protein) intake of enteral formula data documented in medical records of patients that consumed enteral tube feeding formulas at home.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enteral formula standard		Children fed an intact protein formula	Other: Enteral Tube Feeding
Enteral formula semi-elemental		Children fed a semi-elemental protein formula	Other: Enteral Tube Feeding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enteral Tube Feeding	Other	Enteral tube feeding	Enteral formula semi-elemental Enteral formula standard

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nutrition Intake	Assessment of enteral formula calorie and protein intake compared to nutrition prescription	12 months

Secondary Outcomes

Measure	Description	Time Frame
Body weight	Weight in kilograms	12 months
Length/height	Length/height (based on age) in centimeters	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minimum 12 months enteral feeding
History of enteral feeding with intact or semi-elemental formula

Exclusion Criteria:

Medical records lacking enteral nutrition feeding use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Population studied retrospectively will be children with a history of enteral tube feeding in a home setting and meeting inclusion/exclusion criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Ohio Specialty Care		Columbus	Ohio	43228	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D015362	Child Nutrition Disorders

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided