Acute Necrotizing EncephalopathyNCT05853159
Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital
An observational study of Acute Necrotizing Encephalopathy, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Acute Necrotizing Encephalopathy
- What is being tested?
- Basic Laboratory investigations , Cerebrospinal fluid analysis
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Children known to have metabolic disease. Children who have picture of CNS infection \& confirmed by CSF analysis.
Trial locations and contacts
1 site in 1 country.
Abdelrahim A Sadek, Professor contact
About this study
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
- Encephalopathy preceded by viral febrile illness with rapid deterioration in the level of consciousness and convulsions.
- Absent cerebrospinal fluid (CSF) pleocytosis.
- Symmetric multifocal brain lesions.
- Elevation in serum aminotransferase levels.
- 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
- Conditions
- Acute Necrotizing Encephalopathy
- Being tested
- Basic Laboratory investigations , Cerebrospinal fluid analysis
- Medical subject headings
- Leukoencephalitis, Acute Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Laboratory investigations , Cerebrospinal fluid analysisOther
Also called MRI brain
to detect severity and prognostic factors of Acute Necrotizing Encephalopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute necrotizing encephalitis severity score
Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Necrotizing EncephalopathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mahmoud Fathy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853159
- Sponsor's protocol ID
- Soh-med-23-04-07-MS
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33163461Levine 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.
PubMed 32426208Wu 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.
PubMed 35688614Song 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.
PubMed 33388740
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05853159
- Acronym / sponsor ID
- Soh-med-23-04-07-MS
- Conditions
- Acute Necrotizing Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Encephalopathy preceded by viral febrile illness with rapid deterioration in the level of consciousness and convulsions.
- Absent cerebrospinal fluid (CSF) pleocytosis.
- Symmetric multifocal brain lesions.
- Elevation in serum aminotransferase levels.
- 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children known to have metabolic disease. Children who have picture of CNS infection \& confirmed by CSF analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Laboratory investigations , Cerebrospinal fluid analysisAlso: MRI brainto detect severity and prognostic factors of Acute Necrotizing Encephalopathy | Other | – |
Primary outcome
Acute necrotizing encephalitis severity score
Time frame: one year
Clinical and Radiological Prognostic Factors of Acute Necrotizing Encephalopathy in Sohag University Hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 33163461Bashiri 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.
- Background: PubMed 32426208Levine 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.
- Background: PubMed 35688614Wu 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.
- Background: PubMed 33388740Song 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelrahim A Sadek, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Necrotizing Encephalopathy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa M fathy, resident (01033999370, marwamahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute necrotizing encephalitis severity score (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853159, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.