Feeding Trial in Pediatric Patients | NCT01469117

Studies
Feeding Trial in Pediatric Patients

NCT01469117

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Aug 7, 2014Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Developmental Disabilities

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

Aug 2014

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

Nov 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Nov 8, 2011

First Submission Date that Met QC Criteria

Nov 8, 2011

First Posted Date

Nov 10, 2011Estimated

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

Aug 6, 2014

Last Update Posted Date

Aug 7, 2014Estimated

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 is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.

Detailed Description

This prospective observational study seeks to assess ability to achieve enteral feeding goals with a new tube feeding product in pediatric patients with developmental disabilities.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric developmental disabilities		Children aged 1-13 years old with development disabilities, requiring enteral tube feeding for at least 14 days	Other: enteral formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
enteral formula	Other	Complete feeding of study enteral formula, route and regimen prescribed by the physician	Pediatric developmental disabilities

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to feeding goal achievement		up to 14 days

Secondary Outcomes

Measure	Description	Time Frame
Gastrointestinal measures assessment		up to 21 days
Percentage of nutrition goal met		daily up to 21 days
Serum biochemical markers assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Child aged 1-13 years old with development disabilities
Currently tolerating enteral feeding
Requiring nutritional management to meet 50-90th% weight for age on the Kennedy Kreiger Growth Charts
Requires enteral tube feeding for at least 14 days.

Exclusion Criteria:

Unable to access gastrointestinal tract for feeding via tube
Other condition which contraindicates tube feeding

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

Pediatric patients with developmental disabilities

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darin Brannan, MD	The Children's Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children's Center		Bethany	Oklahoma	73008	United States

Condition Browse Module

MeSH Terms

ID	Term
D002658	Developmental Disabilities

Ancestor Terms

ID	Term
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided