Retrospective Review of Amino Acid Formula Use at a Child... | NCT03497091

Studies
Retrospective Review of Amino Acid Formula Use at a Children's Center

NCT03497091

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 19, 2019Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Children Requiring Amino Acid-based Formula Tube Feeding
Enteral Feeding Intolerance

Interventions

Enteral 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

Nov 2019

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

Jun 15, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Apr 5, 2018

First Submission Date that Met QC Criteria

Apr 5, 2018

First Posted Date

Apr 13, 2018Actual

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

Nov 18, 2019

Last Update Posted Date

Nov 19, 2019Actual

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

This is a retrospective review of data documented in medical records.

Detailed Description

This is a retrospective review of data documented in medical records of patients consuming an amino-acid based enteral formula at a pediatric care facility in the United States.

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

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enteral Tube fed children		Enteral Formula	Other: Enteral Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enteral Formula	Other	Enteral Feeding with an amino acid-based formula	Enteral Tube fed children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Documented indication for formula use	Medical diagnosis	Up to 12 months before formula switch

Secondary Outcomes

Measure	Description	Time Frame
Body weight	Body weight in kilograms	12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switch
Length/height	Length or height (based on age) in centimeters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consuming or with a history of consuming an amino acid-based formula

Exclusion Criteria:

Medical records lacking information on consumption of an amino acid-based formula

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

The population studied retrospectively will be children in a pediatric feeding center consuming an amino acid-based enteral fomula and meeting the 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
Children's Center for Rehabilitation Hospital		Oklahoma City	Oklahoma	73008	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