Effect of Nutritional Supplementation on Pediatric Burn P... | NCT01464866

Studies
Effect of Nutritional Supplementation on Pediatric Burn Patients

NCT01464866

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Sep 6, 2012Estimated

Enrollment

116Actual

Phase

Phase 3

Conditions

Burns

Interventions

Nutritional Supplement
Hospital food

Countries

Russia

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 2011

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

Feb 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Nov 1, 2011

First Submission Date that Met QC Criteria

Nov 2, 2011

First Posted Date

Nov 4, 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

Sep 4, 2012

Last Update Posted Date

Sep 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.

Detailed Description

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hospital Feed	Active Comparator	Standard hospital food	Other: Hospital food
Hospital Feed plus nutritional supplement	Experimental	Standard hospital food plus nutritional supplement	Other: Nutritional Supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutritional Supplement	Other	Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.	Hospital Feed plus nutritional supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prealbumin		Change between Baseline and Day 14

Secondary Outcomes

Measure	Description	Time Frame
Preablumin		Change between Baseline and Day 7
C Reactive Protein (CRP)		Between baseline and Day 7
C Reactive Protein

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1-10 years of age
Hospital admission within 24 hours post-burn
At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
Capable of exclusive oral feeding within 3 days of hospitalization
Expected to be hospitalized at least 14 days

Exclusion Criteria:

History diabetes or stress-induced hyperglycemia
Artificial ventilation
Requires parenteral or enteral feeding
IV albumin
Drug that affects metabolism
Receiving Dialysis
Acutely impacted or constipated
Consumes non-study nutritional supplement
Allergy or intolerance to any study product ingredient
Participating in non-Abbott approved concomitant trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Williams, MPH	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic		Izhevsk		426039	Russia

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements
D005521	Food Service, Hospital

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided