Enteral Formula Tolerance in Pediatric Patients | NCT02779335

Studies
Enteral Formula Tolerance in Pediatric Patients

NCT02779335

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Oct 21, 2016Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

Enteral Nutrition

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

Mar 2016

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

May 2016

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Mar 18, 2016

First Submission Date that Met QC Criteria

May 18, 2016

First Posted Date

May 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

Oct 20, 2016

Last Update Posted Date

Oct 21, 2016Estimated

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

The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.

Detailed Description

In this prospective study, a population of stable, tube-fed children will consume a standard polymetric tube feeding formula to assess ability to achieve enteral feeding goals and tolerance outcomes.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enteral formula tube feeding	Other	Enteral fed children, ages 1-13, with establish enteral feeding access	Other: Enteral Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enteral Formula	Other	pediatric subjects will be fed a standard pediatric enteral formula tube feeding	Enteral formula tube feeding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily percentage of caloric nutritional goal met		9 days

Secondary Outcomes

Measure	Description	Time Frame
Daily percentage of protein goal met		9 days
Daily assessment of gastrointestinal tolerance - stool consistency	Daily assessment of stool consistency (liquid, formed, soft)	9 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1 - 13 years of age
Currently tolerating enteral feeding
Has enteral access
Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 9 days
Having obtained his/her and/or his/her legal representative's informed consent

Exclusion Criteria:

Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
Lack of enteral access
Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
Judged to be at risk for poor compliance to the study protocol
Lack of informed consent
Currently participating in another conflicting clinical trial

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerard Minor, MMS, PA-C	Children's Center for GI and Nutrition	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Center for GI and Nutrition		Hollywood	Florida	33021	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