Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital

May 7, 2023 updated by: Marwa Mahmoud Fathy, Sohag University

Acute necrotizing encephalopathy of childhood (ANEC) is a fulminant type of encephalopathy. Most reported cases occur in Asian children with the highest prevalence among patients between the age of 6 and 18 months. The most common clinical presentations are fever, rapid alteration in the level of consciousness, and seizures, in addition to characteristic findings in brain imaging that include, but are not limited to, bilateral thalamic lesions with supra and infra-tentorial lesions of variable dimensions.

The diagnosis of ANEC was determined by specific diagnostic criteria as described by Mizuguchi [1] which consist of

  1. Encephalopathy preceded by viral febrile illness with rapid deterioration in the level of consciousness and convulsions.
  2. Absent cerebrospinal fluid (CSF) pleocytosis.
  3. Symmetric multifocal brain lesions.
  4. Elevation in serum aminotransferase levels.
  5. Exclusion of similar diseases. The ANE severity score was used to assess the severity of illness after admission for shock (3 points), brainstem lesions (2 points), age >4 years (2 points), platelet (PLT) count < 100,000 (1 point), and elevated CSF protein (1 point) was observed. [3] A total score of 9

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Abdelrahim A Sadek, Professor

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag university Hospital
        • Contact:
          • Magdy M Amin, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged from 2months up to 12 years admitted to the pediatric emergency department or pediatric ICU presented with Acute encephalopathy & meet diagnostic criteria of acute necrotizing encephalopathy or come for follow up in our outpatient clinic.

Description

Inclusion Criteria:

- Children aged from 2months up to 12 years admitted to the pediatric emergency department or pediatric ICU presented with Acute encephalopathy & meet diagnostic criteria of acute necrotizing encephalopathy or come for follow up in our outpatient clinic.

Exclusion Criteria:

  • Children known to have metabolic disease. Children who have picture of CNS infection & confirmed by CSF analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute necrotizing encephalitis severity score
Time Frame: one year
Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

May 7, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 7, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-med-23-04-07-MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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