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

NCT05751174 | Completed DMC

• 1 other identifier: 3935
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

nerve growth factor; pediatric patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

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

Interventions

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.

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients from 1 month to 17 years of age suffering from severe burns, i.e. II/III degree and involving more than 8-10% of the body surface admitted to the Pediatric Intensive Care Unit.

You may qualify if:

• Patients suffering from severe burns

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Giorgio Conti

Rome, 00168, Italy

Location

Related Publications (4)

• Pincelli C, Sevignani C, Manfredini R, Grande A, Fantini F, Bracci-Laudiero L, Aloe L, Ferrari S, Cossarizza A, Giannetti A. Expression and function of nerve growth factor and nerve growth factor receptor on cultured keratinocytes. J Invest Dermatol. 1994 Jul;103(1):13-8. doi: 10.1111/1523-1747.ep12388914.

  PMID: 8027574 RESULT

• Wu C, Boustany L, Liang H, Brennan TJ. Nerve growth factor expression after plantar incision in the rat. Anesthesiology. 2007 Jul;107(1):128-35. doi: 10.1097/01.anes.0000267512.08619.bd.

  PMID: 17585224 RESULT

• Matsuda H, Koyama H, Sato H, Sawada J, Itakura A, Tanaka A, Matsumoto M, Konno K, Ushio H, Matsuda K. Role of nerve growth factor in cutaneous wound healing: accelerating effects in normal and healing-impaired diabetic mice. J Exp Med. 1998 Feb 2;187(3):297-306. doi: 10.1084/jem.187.3.297.

  PMID: 9449710 RESULT

• Micera A, Vigneti E, Pickholtz D, Reich R, Pappo O, Bonini S, Maquart FX, Aloe L, Levi-Schaffer F. Nerve growth factor displays stimulatory effects on human skin and lung fibroblasts, demonstrating a direct role for this factor in tissue repair. Proc Natl Acad Sci U S A. 2001 May 22;98(11):6162-7. doi: 10.1073/pnas.101130898. Epub 2001 May 8.

  PMID: 11344264 RESULT

MeSH Terms

Conditions

Burns; Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

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

Study Officials

• Giorgio GC Conti, Professor

  Fondazione Policlinico Gemelli IRCCS, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: March 18, 2021
• Primary Completion: May 26, 2022
• Study Completion: August 30, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

IT (1)