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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burns Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Wounds and Injuries

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Giorgio Conti

Rome, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pediatric patients affected by severe burns

Other

All patients admitted to the pediatric intensive care unit affected by severe burns involving more than 10% of the body surface will be enrolled.

Primary outcomes

Qualitative description of NGF values in severely burned pediatric patients.

Time frame: up to 30 days

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

Secondary outcomes

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.

Time frame: From date of inclusion in the study until 30 days after admission in pediatric intensive care

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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Mar 2, 2023
Registry last updated: Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed