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Not yet recruitingNCT07241858encephalitisUpdated Nov 21, 2025

Clinicolaboratory Predictors of Outcome in Children With Encephalitis

An observational study in Encephalitis in Children and Encephalitis, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
1 Month to 18 Years
Sex
All
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Study 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 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).

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Conditions studied

  • Encephalitis in Children
  • Encephalitis

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In context

Encephalitis

125 studies on the registry are indexed under Encephalitis; 33 are open to participants now.

This study's planned enrollment of 90 is below the median of 300 across 54 observational studies indexed under Encephalitis.

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Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Children with encephalitis

    Diagnostic Test: CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)

Interventions

  • Diagnostic testCSF analysis and culture including S100B,Neuron Specific Enolase(NSE)

    CSF analysis and culture including S100B,Neuron Specific Enolase(NSE)

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

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Study locations

1 site
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References and documents

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 40310303 ↗
  • Aneja 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 30232787 ↗
  • Shiihara 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07241858
Lead sponsor
Assiut University
Responsible party
Noha Mostafa Sayed Mostafa (Assistant Lecturer, Assiut University) — Principal investigator
First posted
Nov 21, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Nov 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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