BurnsNCT05751174
Determination of Nerve Growth Factor (NGF) Expression in Pediatric Patients With Severe Burns: a Pilot Study
An observational study of Burns, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Burns
- What is being tested?
- pediatric patients affected by severe burns
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 18 Mar 2021to 30 Aug 2022
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Patients suffering from severe burns
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Burns
- Being tested
- pediatric patients affected by severe burns
- Keywords
- nerve growth factor, pediatric patient
- Medical subject headings
- Burns, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pediatric patients affected by severe burnsOther
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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: From date of inclusion in the study until 30 days after admission in pediatric intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start18 Mar 2021
- Primary completion26 May 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conti Giorgio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Giorgio GC Conti, Professor, Principal investigator, Fondazione Policlinico Gemelli IRCCS, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751174
- Sponsor's protocol ID
- 3935
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We await the final analysis of the data to evaluate the definitive sharing of the collected data
Publications
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.
PubMed 8027574Wu 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.
PubMed 17585224Matsuda 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.
PubMed 9449710Micera 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.
PubMed 11344264
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Nerve Growth Factor (NGF) Expression in Pediatric Patients With Severe Burns: a Pilot Study
- ClinicalTrials.gov ID
- NCT05751174
- Acronym / sponsor ID
- 3935
- Conditions
- Burns
- Keywords
- nerve growth factor, pediatric patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 2 Mar 2023 (actual)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Patients suffering from severe burns
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pediatric patients affected by severe burnsAll patients admitted to the pediatric intensive care unit affected by severe burns involving more than 10% of the body surface will be enrolled. | Other | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Results publication: PubMed 8027574Pincelli 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.
- Results publication: PubMed 17585224Wu 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.
- Results publication: PubMed 9449710Matsuda 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.
- Results publication: PubMed 11344264Micera 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.
- Individual participant dataSharing planned: Undecided. We await the final analysis of the data to evaluate the definitive sharing of the collected data
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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.
Giorgio GC Conti, Professor principal investigator
Fondazione Policlinico Gemelli IRCCS, Rome
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, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 2 Mar 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Qualitative description of NGF values in severely burned pediatric patients. (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05751174, which also lists 4 linked publications.
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 2 Mar 2023.