Tolerance of a Calorically Dense Enteral Nutrition Formula | NCT02806427

Studies
Tolerance of a Calorically Dense Enteral Nutrition Formula

NCT02806427

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Jul 2, 2017Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Enteral Feeding

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

Jun 2017

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 30, 2016Actual

Primary Completion Date

Mar 11, 2017Actual

Completion Date

Mar 11, 2017Actual

First Submitted Date

Jun 16, 2016

First Submission Date that Met QC Criteria

Jun 16, 2016

First Posted Date

Jun 20, 2016Estimated

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 29, 2017

Last Update Posted Date

Jul 2, 2017Actual

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 prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.

Detailed Description

Not provided

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

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
enterally fed adults		Adults subjects with a condition for which a calorically dense enteral formula is appropriate, with established enteral access, anticipated to require enteral tube feeding for at least 3 days.	Other: Enteral Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enteral Formula	Other		enterally fed adults

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily percentage of caloric nutritional goal met		First 3 days in the ICU

Secondary Outcomes

Measure	Description	Time Frame
Daily percentage of protein goal met		First 5 days in the ICU
Adverse events and serious adverse events		First 5 days in the ICU

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult aged > 18 years
Admitted to Medical ICU with expected admission of ≥ 3 days
Established enteral access
Having obtained his/her or legal representative's informed consent.

Exclusion Criteria:

Pregnant or lactating
Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
Lack of enteral access
Parenteral nutrition
Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.)
Subject who in the Investigator's assessment cannot be expected to comply with study protocol
Currently participating in another conflicting clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with established enteral access receiving standard tube feeding formula in the ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Allen, MD	Oklahoma University Health Sciences Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OUHSC		Oklahoma City	Oklahoma	73104	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