ChildrenNCT07858409
Phoenixin and Pain in Pediatric Burn Patients
An observational study of Children and Acute Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This prospective, controlled, observational study aims to investigate the relationship between phoenixin (PNX) levels and pain in pediatric burn patients. A total of 87 prepubertal children under 18 years of age will be included and evaluated in three independent groups: 29 children with second-degree burns in the… Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Acute Pain, Burn Pain
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will consist of pediatric participants prospectively recruited at Ankara Bilkent City Hospital. The acute burn group will include children with acute second-degree burn injuries who are being followed and treated in the pediatric burn intensive care unit. The chronic burn group will consist of children with a previous burn injury, with at least three months elapsed since the burn, who are evaluated during follow-up after the acute phase. The healthy control group will consist of children without a history of burn injury who are evaluated at the same institution. Eligible participants will be consecutively enrolled from the relevant clinical units during the study period. The three groups will constitute the source population for the comparative evaluation of blood and urine phoenixin levels and their relationship with pain and burn-related clinical characteristics.
Who may be able to join
- Children younger than 18 years of age who have not entered puberty.
- Both sexes are eligible.
- Written informed consent for participation in the study obtained from a parent or legal guardian.
- For the acute burn group: children with second-degree burns who are being followed in the burn intensive care unit.
- For the chronic burn group: a history of burn injury, with at least three months elapsed since the burn.
- For the control group: no history of burn injury and no acute pain at the time of assessment.
Who cannot join
- Neurological, endocrine, or active systemic inflammatory disease that may affect phoenixin (PNX) levels or pain assessment.
- Having entered puberty.
- Inability to obtain the biological samples required for the study.
- Lack of written informed consent from a parent or legal guardian.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara City Hospital Bilkent
Ankara, Ankara, 06800
Feyza SEVER, MD, +903125526000, feyza.altay@hotmail.com
ESRA PIRIL AĞIRBAŞ, MD
About this study
Official title: Evaluation of the Pain-Related Potential of Phoenixin as a Biomarker in Pediatric Burn Patients
This prospective, controlled, observational study aims to investigate the relationship between phoenixin (PNX) levels and pain in pediatric burn patients. A total of 87 prepubertal children under 18 years of age will be included and evaluated in three independent groups: 29 children with second-degree burns in the acute burn period and experiencing pain at the time of assessment, 29 children with a history of burn injury at least three months previously who have completed the acute burn and procedural pain period, and 29 age-similar healthy controls without a history of burns or acute pain.
Blood and urine samples will be collected from all participants, and PNX levels will be measured using an enzyme-linked immunosorbent assay (ELISA). Pain intensity will be assessed using age-appropriate validated pain assessment tools, including the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Visual Analog Scale (VAS), as appropriate. In the burn groups, burn characteristics, including total body surface area (TBSA), will also be recorded.
The study will compare blood and urine PNX levels among the acute burn, chronic burn, and healthy control groups and will evaluate the relationship between PNX levels and clinical pain intensity in children with acute burns. Secondary analyses will examine the relationships between blood and urine PNX levels and their associations with TBSA and demographic and clinical characteristics. The findings are expected to provide preliminary clinical data on the potential role of PNX as a pain-related biological marker in pediatric burn patients.
Read the detailed description
Phoenixin (PNX) is a neuropeptide with diverse physiological functions, and experimental findings suggest that it may be involved in nociceptive pathways. However, its relationship with clinical pain, particularly acute pain in pediatric burn patients, has not been well established. Pediatric burn pain is a dynamic clinical condition influenced by both the burn injury itself and repeated painful procedures, and objective biological measures that complement clinical pain assessment may contribute to a better understanding of its underlying mechanisms.
This study is designed to investigate the potential relationship between PNX levels and pain in pediatric burn patients by evaluating PNX in both blood and urine. Three clinically distinct populations will be assessed: children in the acute phase of second-degree burn injury with pain at the time of assessment, children with a history of burn injury at least three months previously who are beyond the acute burn and procedural pain period, and age-similar healthy children without acute pain or a history of burns. This design will allow PNX levels observed during acute burn-related pain to be interpreted in comparison with both the post-acute burn period and a population without burn injury or acute pain.
PNX measurements will be evaluated together with age-appropriate clinical pain scores and burn-related characteristics, including total body surface area. Blood and urine PNX levels will also be examined in relation to each other. The study is exploratory and is intended to generate preliminary clinical evidence regarding the potential role of PNX as a pain-related biological marker rather than to establish PNX as a validated diagnostic biomarker for pain.
- Conditions
- Children, Acute Pain, Burn Pain, Burn Degree Second
- Keywords
- Phoenixin, Pediatric Burns, Pain Biomarker, Burn Pain, PNX
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Acute Burn Group | Children with second-degree burn injuries who are in the acute burn period and have pain at the time of assessment. Blood and urine samples will be collected for measurement of phoenixin levels, and pain intensity will be assessed using age-appropriate validated pain scales. Burn characteristics, including total body surface area (TBSA), will also be recorded. | |
| 2. Chronic Burn Group | Children with a history of burn injury at least three months previously who have completed the acute burn and procedural pain period. Blood and urine samples will be collected for measurement of phoenixin levels. | |
| 3. Healthy Control Group | Age-similar children without a history of burn injury or acute pain. Blood and urine samples will be collected for measurement of phoenixin levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Blood and Urine Phoenixin Levels Among the Study Groups
Blood and urine phoenixin (PNX) concentrations measured by enzyme-linked immunosorbent assay (ELISA) will be compared among the acute burn, chronic burn, and healthy control groups.
Measured: At the time of study enrollment
Association Between Phoenixin Levels and Pain Intensity in the Acute Burn Group
The association between blood and urine PNX concentrations and clinical pain intensity will be evaluated in children with acute burns. Pain intensity will be assessed using an age-appropriate validated pain assessment scale (FLACC or VAS, as applicable).
Measured: At the time of study enrollment
Secondary outcomes (3)
Association Between Blood and Urine Phoenixin Levels
The association between blood and urine phoenixin (PNX) concentrations will be evaluated to determine whether PNX levels measured in urine are correlated with those measured in blood.
Measured: At the time of study enrollment
Association Between Phoenixin Levels and Total Body Surface Area
The association between blood and urine PNX concentrations and total body surface area (TBSA) affected by burn injury will be evaluated in pediatric burn patients.
Measured: At the time of study enrollment
Association Between Phoenixin Levels and Demographic and Clinical Characteristics
Associations between blood and urine PNX concentrations and demographic and clinical characteristics, including age, sex, and body mass index (BMI), will be evaluated.
Measured: At the time of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Firat University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858409
- Sponsor's protocol ID
- E2-25-12757
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pain-Related Potential of Phoenixin as a Biomarker in Pediatric Burn Patients
- ClinicalTrials.gov ID
- NCT07858409
- Acronym / sponsor ID
- E2-25-12757
- Conditions
- Children, Acute Pain, Burn Pain, Burn Degree Second
- Keywords
- Phoenixin, Pediatric Burns, Pain Biomarker, Burn Pain, PNX
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Firat University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 5 Oct 2026 (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.
This prospective, controlled, observational study aims to investigate the relationship between phoenixin (PNX) levels and pain in pediatric burn patients. A total of 87 prepubertal children under 18 years of age will be included and evaluated in three independent groups: 29 children with second-degree burns in the acute burn period and experiencing pain at the time of assessment, 29 children with a history of burn injury at least three months previously who have completed the acute burn and procedural pain period, and 29 age-similar healthy controls without a history of burns or acute pain.
Blood and urine samples will be collected from all participants, and PNX levels will be measured using an enzyme-linked immunosorbent assay (ELISA). Pain intensity will be assessed using age-appropriate validated pain assessment tools, including the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Visual Analog Scale (VAS), as appropriate. In the burn groups, burn characteristics, including total body surface area (TBSA), will also be recorded.
The study will compare blood and urine PNX levels among the acute burn, chronic burn, and healthy control groups and will evaluate the relationship between PNX levels and clinical pain intensity in children with acute burns. Secondary analyses will examine the relationships between blood and urine PNX levels and their associations with TBSA and demographic and clinical characteristics. The findings are expected to provide preliminary clinical data on the potential role of PNX as a pain-related biological marker in pediatric burn patients.
Detailed description
Phoenixin (PNX) is a neuropeptide with diverse physiological functions, and experimental findings suggest that it may be involved in nociceptive pathways. However, its relationship with clinical pain, particularly acute pain in pediatric burn patients, has not been well established. Pediatric burn pain is a dynamic clinical condition influenced by both the burn injury itself and repeated painful procedures, and objective biological measures that complement clinical pain assessment may contribute to a better understanding of its underlying mechanisms.
This study is designed to investigate the potential relationship between PNX levels and pain in pediatric burn patients by evaluating PNX in both blood and urine. Three clinically distinct populations will be assessed: children in the acute phase of second-degree burn injury with pain at the time of assessment, children with a history of burn injury at least three months previously who are beyond the acute burn and procedural pain period, and age-similar healthy children without acute pain or a history of burns. This design will allow PNX levels observed during acute burn-related pain to be interpreted in comparison with both the post-acute burn period and a population without burn injury or acute pain.
PNX measurements will be evaluated together with age-appropriate clinical pain scores and burn-related characteristics, including total body surface area. Blood and urine PNX levels will also be examined in relation to each other. The study is exploratory and is intended to generate preliminary clinical evidence regarding the potential role of PNX as a pain-related biological marker rather than to establish PNX as a validated diagnostic biomarker for pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Acute Burn Group | – | –Children with second-degree burn injuries who are in the acute burn period and have pain at the time of assessment. Blood and urine samples will be collected for measurement of phoenixin levels, and pain intensity will be assessed using age-appropriate validated pain scales. Burn characteristics, including total body surface area (TBSA), will also be recorded. |
| 2. Chronic Burn Group | – | –Children with a history of burn injury at least three months previously who have completed the acute burn and procedural pain period. Blood and urine samples will be collected for measurement of phoenixin levels. |
| 3. Healthy Control Group | – | –Age-similar children without a history of burn injury or acute pain. Blood and urine samples will be collected for measurement of phoenixin levels. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of pediatric participants prospectively recruited at Ankara Bilkent City Hospital. The acute burn group will include children with acute second-degree burn injuries who are being followed and treated in the pediatric burn intensive care unit. The chronic burn group will consist of children with a previous burn injury, with at least three months elapsed since the burn, who are evaluated during follow-up after the acute phase. The healthy control group will consist of children without a history of burn injury who are evaluated at the same institution. Eligible participants will be consecutively enrolled from the relevant clinical units during the study period. The three groups will constitute the source population for the comparative evaluation of blood and urine phoenixin levels and their relationship with pain and burn-related clinical characteristics.
Key inclusion criteria (6 listed)
- Children younger than 18 years of age who have not entered puberty.
- Both sexes are eligible.
- Written informed consent for participation in the study obtained from a parent or legal guardian.
- For the acute burn group: children with second-degree burns who are being followed in the burn intensive care unit.
- For the chronic burn group: a history of burn injury, with at least three months elapsed since the burn.
Key exclusion criteria (4 listed)
- Neurological, endocrine, or active systemic inflammatory disease that may affect phoenixin (PNX) levels or pain assessment.
- Having entered puberty.
- Inability to obtain the biological samples required for the study.
- Lack of written informed consent from a parent or legal guardian.
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
Difference in Blood and Urine Phoenixin Levels Among the Study Groups
Time frame: At the time of study enrollment
Blood and urine phoenixin (PNX) concentrations measured by enzyme-linked immunosorbent assay (ELISA) will be compared among the acute burn, chronic burn, and healthy control groups.
Association Between Phoenixin Levels and Pain Intensity in the Acute Burn Group
Time frame: At the time of study enrollment
The association between blood and urine PNX concentrations and clinical pain intensity will be evaluated in children with acute burns. Pain intensity will be assessed using an age-appropriate validated pain assessment scale (FLACC or VAS, as applicable).
3 secondary outcomes
Association Between Blood and Urine Phoenixin Levels
Time frame: At the time of study enrollment
Association Between Phoenixin Levels and Total Body Surface Area
Time frame: At the time of study enrollment
Association Between Phoenixin Levels and Demographic and Clinical Characteristics
Time frame: At the time of study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Children and Acute Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 6 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feyza SEVER, Assoc Prof (+903125526000, feyza.altay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Blood and Urine Phoenixin Levels Among the Study Groups (time frame: At the time of study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 5 Oct 2026.