Clinical trial NCT05853159: Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital
Official title: Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Necrotizing Encephalopathy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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. 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


Eligibility criteria: 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.

Primary outcomes:
measure: Acute necrotizing encephalitis severity score
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.