Encephalitis in ChildrenencephalitisNCT07241858
Clinicolaboratory Predictors of Outcome in Children With Encephalitis
An observational study of Encephalitis in Children and Encephalitis, run by Assiut University at 1 site in Egypt.
Trial summary
. A glycolytic enzyme called enolase is primarily found in neurons. A dimeric isoform of enolase called neuron-specific enolase (NSE) exists. It can be found in neurons, platelets, erythrocytes, and other neuroectodermal cells.It is one of the laboratory biomarkers that could be investigated in cases of… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Encephalitis in Children, Encephalitis
- What is being tested?
- CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Jan 2028
- 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
- No healthy volunteers
- Child, Adult
Study population: 1. Pediatric population aged 1month to 18 years. * Decreased level of consciousness, personality change, or psychiatric manifestations lasting >24 h (in toddlers and infants, may present as increased irritability or lethargy) * No alternative diagnosis to explain presentation * Seizure (new onset) * Fever (≥38.0°C) * Focal neurologic findings (new onset) * CSF WBC ≥5/mm3 * Acute abnormality on brain MRI
Who may be able to join
- 1. Pediatric population aged 1month to 18 years.
- Decreased level of consciousness, personality change, or psychiatric manifestations lasting >24 h (in toddlers and infants, may present as increased irritability or lethargy)
- No alternative diagnosis to explain presentation
- Seizure (new onset)
- Fever (≥38.0°C)
- Focal neurologic findings (new onset)
- CSF WBC ≥5/mm3
Who cannot join
- 1. Neonates and adults ( <1 month or >18 years) 2. If they had a diagnosis of delirium or encephalopathy secondary to sepsis, toxins,renal ,hepatic or metabolic causes (hypoglycemia, electrolyte disturbances
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
. A glycolytic enzyme called enolase is primarily found in neurons. A dimeric isoform of enolase called neuron-specific enolase (NSE) exists. It can be found in neurons, platelets, erythrocytes, and other neuroectodermal cells.It is one of the laboratory biomarkers that could be investigated in cases of encephalopathy, which can be found in both blood and cerebrospinal fluid, might be a helpful biomarker for determining brain injury prognosis and neuronal damage.(4) High S-100beta levels were associated with higher intensive care unit mortality and represented the strongest independent predictor of intensive care unit survival, whereas neuron-specific enolase (NSE) and the Glasgow Coma Scale failed to predict fatal outcome.(5) (NSE) and S100B are important as a diagnostic and a prognostic value in pediatric encephalopathy which is common and is potentially life threatening, previous studies were done worldwide to detect its diagnostic and prognostic value in acute encephalopathy among adult and pediatric age groups.(4) ,so we asses (NSE) and S100B to detect the the out come of acute encephalopathy
Read the detailed description
Acute encephalopathy is the generic term for acute brain dysfunction caused by various agents, such as infection, metabolic disease, hepatic or renal dysfunctions, and hypertension;causing change in mental status that affects cognition or level of alertness in the patient. The pathological substrate of acute encephalopathy is diffuse or widespread non-inflammatory brain edema..(1) The key for establishing evidence of central nervous system (CNS) inflammation is the analysis of CSF. Lumbar puncture (LP) is often excessively delayed, primarily due to performing brain imaging to exclude raised intracranial pressure. Not all patients need imaging before LP, and consensus guidelines suggest a few clear indications for imaging. If these are present, then either a computed tomography (CT) scan or, ideally, magnetic resonance imaging (MRI) should be obtained urgently. Following this, if there are no radiological contraindications, LP should be performed as soon as possible. Brain imaging serves three purposes: to look for changes of encephalitis, to exclude alternative diagnoses, and to assess patency of the basal cisterns and an absence of mass effect so that LP can proceed.(2) Biochemical markers can be used in addition to neuroimaging techniques to evaluate the extent of brain injuries and to enable earlier diagnosis and faster intervention. Among the potential biomarkers of brain injuries, neuron-specific enolase (NSE) and S100B are the most frequently studied and were shown to be the most promising.(3).
- Conditions
- Encephalitis in Children, Encephalitis
- Being tested
- CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)
- Medical subject headings
- Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)Diagnostic test
CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)
| Study group | Role | What they receive |
|---|---|---|
| Children with encephalitis | Not described Receives: Diagnostic Test: CSF analysis and culture including S100B,Neuron Specific Enolase(NSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses clinical ,radiological laboratory biomarkers ( CSF Neuron-Specific Enolase and S100B )as outcome predictors of encephalitis
To asses clinical ,radiological laboratory biomarkers ( CSF Neuron-Specific Enolase and S100B )as outcome predictors of encephalitis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Encephalitis in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mostafa Sayed Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241858
- Sponsor's protocol ID
- pediatric encephalitis
- Acronym
- encephalitis
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Makovec M, Skitek M, Simnovec L, Jerin A. Neuron-Specific Enolase and S100B as Biomarkers of Ischemic Brain Injury During Surgery. Clin Pract. 2025 Apr 3;15(4):74. doi: 10.3390/clinpract15040074.
PubMed 40310303Aneja S, Sharma S. Diagnosis and Management of Acute Encephalitis in Children. Indian J Pediatr. 2019 Jan;86(1):70-75. doi: 10.1007/s12098-018-2775-0. Epub 2018 Sep 19.
PubMed 30232787Shiihara T, Miyake T, Izumi S, Watanabe M, Kamayachi K, Kodama K, Nabetani M, Ikemiyagi M, Yamaguchi Y, Sawaura N. Serum and cerebrospinal fluid S100B, neuron-specific enolase, and total tau protein in acute encephalopathy with biphasic seizures and late reduced diffusion: a diagnostic validity. Pediatr Int. 2012 Feb;54(1):52-5. doi: 10.1111/j.1442-200X.2011.03454.x. Epub 2011 Oct 30.
PubMed 21883688
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicolaboratory Predictors of Outcome in Children With Encephalitis
- ClinicalTrials.gov ID
- NCT07241858
- Acronym / sponsor ID
- encephalitis / pediatric encephalitis
- Conditions
- Encephalitis in Children, Encephalitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 21 Nov 2025 (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.
. A glycolytic enzyme called enolase is primarily found in neurons. A dimeric isoform of enolase called neuron-specific enolase (NSE) exists. It can be found in neurons, platelets, erythrocytes, and other neuroectodermal cells.It is one of the laboratory biomarkers that could be investigated in cases of encephalopathy, which can be found in both blood and cerebrospinal fluid, might be a helpful biomarker for determining brain injury prognosis and neuronal damage.(4) High S-100beta levels were associated with higher intensive care unit mortality and represented the strongest independent predictor of intensive care unit survival, whereas neuron-specific enolase (NSE) and the Glasgow Coma Scale failed to predict fatal outcome.(5) (NSE) and S100B are important as a diagnostic and a prognostic value in pediatric encephalopathy which is common and is potentially life threatening, previous studies were done worldwide to detect its diagnostic and prognostic value in acute encephalopathy among adult and pediatric age groups.(4) ,so we asses (NSE) and S100B to detect the the out come of acute encephalopathy
Detailed description
Acute encephalopathy is the generic term for acute brain dysfunction caused by various agents, such as infection, metabolic disease, hepatic or renal dysfunctions, and hypertension;causing change in mental status that affects cognition or level of alertness in the patient. The pathological substrate of acute encephalopathy is diffuse or widespread non-inflammatory brain edema..(1) The key for establishing evidence of central nervous system (CNS) inflammation is the analysis of CSF. Lumbar puncture (LP) is often excessively delayed, primarily due to performing brain imaging to exclude raised intracranial pressure. Not all patients need imaging before LP, and consensus guidelines suggest a few clear indications for imaging. If these are present, then either a computed tomography (CT) scan or, ideally, magnetic resonance imaging (MRI) should be obtained urgently. Following this, if there are no radiological contraindications, LP should be performed as soon as possible. Brain imaging serves three purposes: to look for changes of encephalitis, to exclude alternative diagnoses, and to assess patency of the basal cisterns and an absence of mass effect so that LP can proceed.(2) Biochemical markers can be used in addition to neuroimaging techniques to evaluate the extent of brain injuries and to enable earlier diagnosis and faster intervention. Among the potential biomarkers of brain injuries, neuron-specific enolase (NSE) and S100B are the most frequently studied and were shown to be the most promising.(3).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with encephalitis | – | Diagnostic Test: CSF analysis and culture including S100B,Neuron Specific Enolase(NSE) |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 1. Pediatric population aged 1month to 18 years. * Decreased level of consciousness, personality change, or psychiatric manifestations lasting >24 h (in toddlers and infants, may present as increased irritability or lethargy) * No alternative diagnosis to explain presentation * Seizure (new onset) * Fever (≥38.0°C) * Focal neurologic findings (new onset) * CSF WBC ≥5/mm3 * Acute abnormality on brain MRI
Key inclusion criteria (7 listed)
- 1. Pediatric population aged 1month to 18 years.
Key exclusion criteria (1 listed)
- 1. Neonates and adults ( <1 month or >18 years) 2. If they had a diagnosis of delirium or encephalopathy secondary to sepsis, toxins,renal ,hepatic or metabolic causes (hypoglycemia, electrolyte disturbances
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 |
|---|---|---|
| CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)CSF analysis and culture including S100B,Neuron Specific Enolase(NSE) | Diagnostic test | Children with encephalitis |
Primary outcome
To asses clinical ,radiological laboratory biomarkers ( CSF Neuron-Specific Enolase and S100B )as outcome predictors of encephalitis
Time frame: 1 month
To asses clinical ,radiological laboratory biomarkers ( CSF Neuron-Specific Enolase and S100B )as outcome predictors of encephalitis
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 21 Nov 2025.
- Background: PubMed 40310303Makovec M, Skitek M, Simnovec L, Jerin A. Neuron-Specific Enolase and S100B as Biomarkers of Ischemic Brain Injury During Surgery. Clin Pract. 2025 Apr 3;15(4):74. doi: 10.3390/clinpract15040074.
- Background: PubMed 30232787Aneja S, Sharma S. Diagnosis and Management of Acute Encephalitis in Children. Indian J Pediatr. 2019 Jan;86(1):70-75. doi: 10.1007/s12098-018-2775-0. Epub 2018 Sep 19.
- Background: PubMed 21883688Shiihara T, Miyake T, Izumi S, Watanabe M, Kamayachi K, Kodama K, Nabetani M, Ikemiyagi M, Yamaguchi Y, Sawaura N. Serum and cerebrospinal fluid S100B, neuron-specific enolase, and total tau protein in acute encephalopathy with biphasic seizures and late reduced diffusion: a diagnostic validity. Pediatr Int. 2012 Feb;54(1):52-5. doi: 10.1111/j.1442-200X.2011.03454.x. Epub 2011 Oct 30.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Encephalitis in Children and Encephalitis, run by Assiut University at 1 site in Egypt.
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 7 inclusion and 1 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 21 Nov 2025. 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 Egypt. 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?
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?
To asses clinical ,radiological laboratory biomarkers ( CSF Neuron-Specific Enolase and S100B )as outcome predictors of encephalitis (time frame: 1 month). 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 NCT07241858, which also lists 3 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 21 Nov 2025.