Determination of Nerve Growth Factor (NGF) Expression in Pediatric Patients With Severe Burns: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to determine the blood values of NGF in severely burned patients, to describe any changes over time and finally to correlate the expression of NGF to the severity of the burn. The main question it aims to answer is: - describe NGF values in severely burned pediatric patients and to evaluate their correlation with the severity of the burn and the extent of the burned skin surface by measuring the circulating levels of NGF in pediatric patients. Participants will undergo blood sampling on days 2,7,14 and 30 after the traumatic event for the clinical follow-up envisaged by the internal protocol.

Detailed Description
-----------------
Severe pediatric burns, characterized by an extension greater than 10% of the total body surface or by the involvement of particular districts such as the hands, face, airways or genitals, are characterized by multisystem involvement, which often requires intensive care support. The epidermis begins to develop from the superficial ectoderm at the end of the fourth week of gestation when the neural tube separates from the overlying ectoderm. Consequently, the ectoderm gives rise to both the nervous system and the epithelium. In particular, the NERVE GROWTH FACTOR (NGF) is a neurotrophic factor that plays a fundamental protective role in the development and survival of neurons. In fetal skin, NGF is synthesized in both the epithelium and mesenchyme, but the highest amounts of NGF messenger ribonucleic acid are found in the epithelium. There are currently no studies investigating the expression of NGF in severe burns. The common embryonic origin of the skin and the neurological system may hold the key to new research opportunities to understand the regenerative response and in particular the role of growth factors such as NGF in the skin repair mechanism in severe burns . The hypothesis of the study is based on the possibility that skin burns may be related to an increased expression of circulating NGF in the blood. However, there are no data in literature on this issue and the behavior of NGF in patients affected by burns is not known, either in adult or pediatric patients. Aim To describe NGF values in severely burned pediatric patients and to evaluate their correlation with the severity of the burn and the extent of the burned skin surface by measuring the circulating levels of NGF.

Official Title
-----------------
Determination of Nerve Growth Factor (NGF) Expression in Pediatric Patients With Severe Burns: a Pilot Study

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Other: pediatric patients affected by severe burns


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from severe burns Exclusion Criteria: Major congenital malformations Antibiotic treatment 48 hours prior to admission Norepinephrine infusion > 0.5 mcg/k/min Lack of informed consent from parents or legal guardians

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pediatric patients affected by severe burns|All patients admitted to the pediatric intensive care unit affected by severe burns involving more than 10% of the body surface will be enrolled.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative description of NGF values in severely burned pediatric patients. | Patients will undergo blood sampling on days 2,7,14 and 30 after the traumatic event for the clinical follow-up envisaged by the internal protocol. A small aliquot of blood (5 ml) will be dedicated separately for the measurement of circulating NGF levels | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the correlation of the extent of NGF expression with the severity of the burn and with the extent of the burned skin surface. | In the protocol we will collect the following demographic and clinical variables: Age, gender, weight, total body surface area (%), Burn depth I II III degree, specific surface involvement (face, genitals, palms and soles), organ failure, use of inotropic and vasoconstrictor drugs, need for intubation and mechanical ventilation, quantification of fluid therapy for shock correction, infectious complications, need for surgery with possible homologous/autologous skin graft. these variables will be included to assess the correlation with NGF values | From date of inclusion in the study until 30 days after admission in pediatric intensive care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nerve growth factor, pediatric patient