EncephalitisNCT07830927
Early Neurological Outcome in Pediatric Encephalitis
An observational study of Encephalitis and Brain Diseases, run by Assiut University.
Trial summary
This prospective cohort study aims to identify baseline clinical, laboratory, and radiological factors at admission that are associated with early neurological outcomes in children with encephalitis admitted to Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Encephalitis, Brain Diseases, Neurologic Manifestations
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 25 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1 month to 12 years admitted to Assiut University Children Hospital with possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition.
Who may be able to join
- Age from 1 month to 12 years
- Possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition
- Written informed consent from parents or legal guardians
Who cannot join
- Pre-existing severe neurodisability pediatric modified Rankin Scale greater than or equal to 3 before the index illness
- Primary diagnosis of traumatic brain injury or cerebral malaria
- Known inborn error of metabolism or neurodegenerative disorder prior to the encephalitis episode
- Absence of documented neurologic outcome assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictors of Early Neurological Outcome in Children With Encephalitis: A Prospective Study From Assiut University Children Hospital
This prospective cohort study aims to identify baseline clinical, laboratory, and radiological factors at admission that are associated with early neurological outcomes in children with encephalitis admitted to Assiut University Children Hospital.
Read the detailed description
Encephalitis in children carries a high risk of neurological sequelae. This observational study will include children aged 1 month to 12 years with possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition.
Baseline clinical, laboratory, neuroimaging, and EEG findings will be recorded. Early neurological outcome will be assessed at hospital discharge using the pediatric modified Rankin Scale (mRS).
- Conditions
- Encephalitis, Brain Diseases, Neurologic Manifestations
- Keywords
- Pediatric encephalitis, Assiut, Modified Rankin Scale, Neurological outcome
- Medical subject headings
- Encephalitis, Brain Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Children with encephalitis | Children aged 1 month to 12 years with possible or probable encephalitis who will be assessed for early neurological outcome at hospital discharge using the pediatric modified Rankin Scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional neurological outcome at discharge
Score on the pediatric modified Rankin Scale at hospital discharge. The scale ranges from 0 (no symptoms) to 6 (death), with higher scores indicating worse functional outcome
Measured: Up to 30 days
Secondary outcomes (4)
Duration of hospital stay
Length of hospital stay in days.
Measured: Up to 30 days
Need for intensive care unit admission
Number of children who require intensive care unit admission
Measured: Up to 30 days
Need for nasogastric tube feeding at discharge
Number of children who require nasogastric tube feeding at the time of hospital discharge
Measured: Up to 30 days
Nosocomial infections
Number of children who develop nosocomial infections during hospitalization
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EncephalitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ahmed Hussein, Assiut University
- Investigators
- Faisel A Ahmed, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830927
- Sponsor's protocol ID
- Encephalitis-Outcome-Assiut-20
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Granerod J, Ambrose HE, Davies NW, Clewley JP, Walsh AL, Morgan D, Cunningham R, Zuckerman M, Mutton KJ, Solomon T, Ward KN, Lunn MP, Irani SR, Vincent A, Brown DW, Crowcroft NS; UK Health Protection Agency (HPA) Aetiology of Encephalitis Study Group. Causes of encephalitis and differences in their clinical presentations in England: a multicentre, population-based prospective study. Lancet Infect Dis. 2010 Dec;10(12):835-44. doi: 10.1016/S1473-3099(10)70222-X. Epub 2010 Oct 15.
PubMed 20952256Venkatesan A, Tunkel AR, Bloch KC, Lauring AS, Sejvar J, Bitnun A, Stahl JP, Mailles A, Drebot M, Rupprecht CE, Yoder J, Cope JR, Wilson MR, Whitley RJ, Sullivan J, Granerod J, Jones C, Eastwood K, Ward KN, Durrheim DN, Solbrig MV, Guo-Dong L, Glaser CA; International Encephalitis Consortium. Case definitions, diagnostic algorithms, and priorities in encephalitis: consensus statement of the international encephalitis consortium. Clin Infect Dis. 2013 Oct;57(8):1114-28. doi: 10.1093/cid/cit458. Epub 2013 Jul 15.
PubMed 23861361Pillai SC, Hacohen Y, Tantsis E, Prelog K, Merheb V, Kesson A, Barnes E, Gill D, Webster R, Menezes M, Ardern-Holmes S, Gupta S, Procopis P, Troedson C, Antony J, Ouvrier RA, Polfrit Y, Davies NW, Waters P, Lang B, Lim MJ, Brilot F, Vincent A, Dale RC. Infectious and autoantibody-associated encephalitis: clinical features and long-term outcome. Pediatrics. 2015 Apr;135(4):e974-84. doi: 10.1542/peds.2014-2702.
PubMed 25802349
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Early Neurological Outcome in Children With Encephalitis: A Prospective Study From Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT07830927
- Acronym / sponsor ID
- Encephalitis-Outcome-Assiut-20
- Conditions
- Encephalitis, Brain Diseases, Neurologic Manifestations
- Keywords
- Pediatric encephalitis, Assiut, Modified Rankin Scale, Neurological outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 21 Sep 2026 (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.
This prospective cohort study aims to identify baseline clinical, laboratory, and radiological factors at admission that are associated with early neurological outcomes in children with encephalitis admitted to Assiut University Children Hospital.
Detailed description
Encephalitis in children carries a high risk of neurological sequelae. This observational study will include children aged 1 month to 12 years with possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition.
Baseline clinical, laboratory, neuroimaging, and EEG findings will be recorded. Early neurological outcome will be assessed at hospital discharge using the pediatric modified Rankin Scale (mRS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Children with encephalitis | – | –Children aged 1 month to 12 years with possible or probable encephalitis who will be assessed for early neurological outcome at hospital discharge using the pediatric modified Rankin Scale. |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1 month to 12 years admitted to Assiut University Children Hospital with possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition.
Key inclusion criteria (3 listed)
- Age from 1 month to 12 years
- Possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition
- Written informed consent from parents or legal guardians
Key exclusion criteria (4 listed)
- Pre-existing severe neurodisability pediatric modified Rankin Scale greater than or equal to 3 before the index illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional neurological outcome at discharge
Time frame: Up to 30 days
Score on the pediatric modified Rankin Scale at hospital discharge. The scale ranges from 0 (no symptoms) to 6 (death), with higher scores indicating worse functional outcome
4 secondary outcomes
Duration of hospital stay
Time frame: Up to 30 days
Need for intensive care unit admission
Time frame: Up to 30 days
Need for nasogastric tube feeding at discharge
Time frame: Up to 30 days
Nosocomial infections
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 20952256Granerod J, Ambrose HE, Davies NW, Clewley JP, Walsh AL, Morgan D, Cunningham R, Zuckerman M, Mutton KJ, Solomon T, Ward KN, Lunn MP, Irani SR, Vincent A, Brown DW, Crowcroft NS; UK Health Protection Agency (HPA) Aetiology of Encephalitis Study Group. Causes of encephalitis and differences in their clinical presentations in England: a multicentre, population-based prospective study. Lancet Infect Dis. 2010 Dec;10(12):835-44. doi: 10.1016/S1473-3099(10)70222-X. Epub 2010 Oct 15.
- Background: PubMed 23861361Venkatesan A, Tunkel AR, Bloch KC, Lauring AS, Sejvar J, Bitnun A, Stahl JP, Mailles A, Drebot M, Rupprecht CE, Yoder J, Cope JR, Wilson MR, Whitley RJ, Sullivan J, Granerod J, Jones C, Eastwood K, Ward KN, Durrheim DN, Solbrig MV, Guo-Dong L, Glaser CA; International Encephalitis Consortium. Case definitions, diagnostic algorithms, and priorities in encephalitis: consensus statement of the international encephalitis consortium. Clin Infect Dis. 2013 Oct;57(8):1114-28. doi: 10.1093/cid/cit458. Epub 2013 Jul 15.
- Background: PubMed 25802349Pillai SC, Hacohen Y, Tantsis E, Prelog K, Merheb V, Kesson A, Barnes E, Gill D, Webster R, Menezes M, Ardern-Holmes S, Gupta S, Procopis P, Troedson C, Antony J, Ouvrier RA, Polfrit Y, Davies NW, Waters P, Lang B, Lim MJ, Brilot F, Vincent A, Dale RC. Infectious and autoantibody-associated encephalitis: clinical features and long-term outcome. Pediatrics. 2015 Apr;135(4):e974-84. doi: 10.1542/peds.2014-2702.
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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.
Faisel A Ahmed, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalitis and Brain Diseases, run by Assiut University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania A Hussein (01280633697, Rania.18313530@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional neurological outcome at discharge (time frame: Up to 30 days). 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 NCT07830927, which also lists 3 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 22 Sep 2026.