Anorexia in Children With Burn Injury and the Reactions o... | NCT00369876

Studies
Anorexia in Children With Burn Injury and the Reactions of the Immune and Endocrine Systems

NCT00369876

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jan 24, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Burns
Anorexia

Interventions

Not provided

Countries

Israel

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

Jan 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Jul 2006

First Submitted Date

Aug 29, 2006

First Submission Date that Met QC Criteria

Aug 29, 2006

First Posted Date

Aug 30, 2006Estimated

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

Jan 23, 2007

Last Update Posted Date

Jan 24, 2007Estimated

Description Module

Brief Summary

Anorexia in children with burn injury is a common phenomenon. The study is searching for the origin of the anorexia in those children. The study correlates between the level peptides of the immune and the endocrine systems and the length of the anorexia.

Detailed Description

Burn injury lead to hypermetabolic set to heal the damaged tissue.Burn healing uses high energy consumption and as consequence is highly There is a huge activation of the endocrine system and immune system resulting a proinflamtory status.

The nutrition component has an important role in the burn healing process by reducing the healing time and also in the quality of the scar tissue. It's been observed that many burn injury patients are suffering from anorexia. Since we know pro-inflammatory status modulate satiety rises the question is there a correlation between the level peptides of the immune and the endocrine systems to anorexia in children with burn injury.

Catecholamines serum concentrations rise following a burn injury. These hormones have an important role in determining the basal metabolic rate (BMR). During the healing process the levels of growth hormone (GH) and Insulin like growth factor I (IGF-1) are reduced. Previous studies show a correlation between these lower levels and Interleukins and cytokines such as Tumor Necrosis Factor (TNF) Interleukin-6 (IL-6). Additional hormones, which are relevant, are cortisol and insulin. Cortisol levels are very high after severe burn injuries for a long period. insulin sensitivity state also has an important role in the healing process.

TNFa and IL-6, which are inflammatory factors, found to have significantly elevated serum concentrations during the healing process. They are also known to be reducers to GH sensitivity and causes anorexia.

This study will show the connection between the immune and the endocrine systems to the burn healing process and anorexia by examining the level of hormones, interleukins and neuropeptide during the burn healing. our goal is to try and improve the treatment in children with burn injury by nutritional or drug intervention.

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age below 16 years
Abilty to feed yourself during hospitalization
Gaining consciousness during hospitalization

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omer bAR-yOSEF, dR.	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba medical center		Tel Litwinsky		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D000855	Anorexia

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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