Clinicolaboratory Predictors of Outcome in Children With Encephalitis

NCT07241858 | Not Yet Recruiting

• 1 other identifier: pediatric encephalitis
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Encephalitis in Children; Encephalitis

Outcome Measures

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

  1 month

Study Arms (1)

Children with encephalitis

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

Interventions

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

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

Children with encephalitis

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71717, Egypt

Location

Related Publications (3)

• 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.

  PMID: 40310303 BACKGROUND

• 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.

  PMID: 30232787 BACKGROUND

• 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.

  PMID: 21883688 BACKGROUND

MeSH Terms

Conditions

Encephalitis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

EG (1)