BurnsNCT00369876
Anorexia in Children With Burn Injury and the Reactions of the Immune and Endocrine Systems
An observational study of Burns and Anorexia, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 6 months to 16 yearsHealthy volunteers can take part
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2004to Jul 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age below 16 years
- Abilty to feed yourself during hospitalization
- Gaining consciousness during hospitalization
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Anorexia and the Level of Hormones, Cytokines and Neuroendocrine Peptides in Children After Burn Injury
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.
Read the 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.
- Keywords
- Burns, Anorexia, Neuropeptide, Leptin, Adiponectin, Gherlin
- Medical subject headings
- Burns, Anorexia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startAug 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Omer bAR-yOSEF, dR., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369876
- Sponsor's protocol ID
- SHEBA-04-3392-OB-CTIL
- Status last verified
- Jan 2007
- First submitted
- 29 Aug 2006
- Last updated
- 24 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Anorexia and the Level of Hormones, Cytokines and Neuroendocrine Peptides in Children After Burn Injury
- ClinicalTrials.gov ID
- NCT00369876
- Acronym / sponsor ID
- SHEBA-04-3392-OB-CTIL
- Keywords
- Burns, Anorexia, Neuropeptide, Leptin, Adiponectin, Gherlin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2004
- Study completion
- Jul 2006
- First posted
- 30 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age below 16 years
- Abilty to feed yourself during hospitalization
- Gaining consciousness during hospitalization
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer bAR-yOSEF, dR. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Anorexia, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2007.