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NCT00369876 Clinical Trial

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

Burns Clinical Trial

Official title:
The Association Between Anorexia and the Level of Hormones, Cytokines and Neuroendocrine Peptides in Children After Burn Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00369876
Other study ID # SHEBA-04-3392-OB-CTIL
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received August 29, 2006
Last updated January 23, 2007
Start date August 2004
Est. completion date July 2006

Study information
Verified date January 2007
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 16 Years
Eligibility Inclusion Criteria:

- Age below 16 years

- Abilty to feed yourself during hospitalization

- Gaining consciousness during hospitalization

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba medical center Tel-Hashomer

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

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