Quantification and Derivation of Metabolic Needs in Child... | NCT00539019

Studies
Quantification and Derivation of Metabolic Needs in Children During Burn Rehabilitation

NCT00539019

Sponsor

Shriners Hospitals for Children

Status

Withdrawn

Last Update Posted

Jun 19, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Burns

Interventions

calories measured 5x following wound healing

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 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

indirect calorimetry no longer employed at the institution; calorimeter is not accurate/reliable

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 1, 2007

First Submission Date that Met QC Criteria

Oct 1, 2007

First Posted Date

Oct 3, 2007Estimated

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 18, 2012

Last Update Posted Date

Jun 19, 2012Estimated

Description Module

Brief Summary

The investigators are collecting information on the calorie needs of patients in the first year postburn. The investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury.

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

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A, observed		measure REE via indirect calorimetry at various time points post burn	Other: calories measured 5x following wound healing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
calories measured 5x following wound healing	Other	measure REE at various time points postburn	A, observed

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>25% burn surface area
Wounds present as 95% healed
Admitted to Shriners Hospital Cincinnati within 7 days of injury

Exclusion Criteria:

<5years old
<25% burn injury
admitted greater than 7 days postburn

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

burned, pediatrics pooled from inpatient acute population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theresa M Mayes, RD,LD	Shriners Hospital for Children, Cincinnati, Ohio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shriners Hospital for Children		Cincinnati	Ohio	45229	United States