NCT05853159

Brief Summary

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. 1.Encephalopathy preceded by viral febrile illness with rapid deterioration in the level of consciousness and convulsions.
  2. 2.Absent cerebrospinal fluid (CSF) pleocytosis.
  3. 3.Symmetric multifocal brain lesions.
  4. 4.Elevation in serum aminotransferase levels.
  5. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

April 19, 2023

Last Update Submit

May 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acute necrotizing encephalitis severity score

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

    one year

Interventions

to detect severity and prognostic factors of Acute Necrotizing Encephalopathy

Also known as: MRI brain

Eligibility Criteria

Age2 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • Bashiri FA, Al Johani S, Hamad MH, Kentab AY, Alwadei AH, Hundallah K, Hasan HH, Alshuaibi W, Jad L, Alrifai MT, Hudairi A, Al Sheikh R, Alenizi A, Alharthi NA, Abdelmagid TA, Ba-Armah D, Salih MA, Tabarki B. Acute Necrotizing Encephalopathy of Childhood: A Multicenter Experience in Saudi Arabia. Front Pediatr. 2020 Oct 9;8:526. doi: 10.3389/fped.2020.00526. eCollection 2020.

    PMID: 33163461BACKGROUND
  • Levine JM, Ahsan N, Ho E, Santoro JD. Genetic Acute Necrotizing Encephalopathy Associated with RANBP2: Clinical and Therapeutic Implications in Pediatrics. Mult Scler Relat Disord. 2020 Aug;43:102194. doi: 10.1016/j.msard.2020.102194. Epub 2020 May 15.

    PMID: 32426208BACKGROUND
  • Wu L, Peng H, Jiang Y, He L, Jiang L, Hu Y. Clinical features and imaging manifestations of acute necrotizing encephalopathy in children. Int J Dev Neurosci. 2022 Aug;82(5):447-457. doi: 10.1002/jdn.10201. Epub 2022 Jun 22.

    PMID: 35688614BACKGROUND
  • Song Y, Li S, Xiao W, Shen J, Ma W, Wang Q, Yang H, Liu G, Hong Y, Li P, Yang S. Influenza-Associated Encephalopathy and Acute Necrotizing Encephalopathy in Children: A Retrospective Single-Center Study. Med Sci Monit. 2021 Jan 3;27:e928374. doi: 10.12659/MSM.928374.

    PMID: 33388740BACKGROUND

MeSH Terms

Conditions

Leukoencephalitis, Acute Hemorrhagic

Condition Hierarchy (Ancestors)

Encephalomyelitis, Acute DisseminatedDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesLeukoencephalopathiesBrain DiseasesCentral Nervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Marwa M fathy, resident

CONTACT

Abdelrahim A Sadek, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric and Neonatology Resident at Sohag University Hospital

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 10, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations