NCT07830927

Brief 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2026

Status
not yet recruiting

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

Study Progress3%
Sep 2026Feb 2028

First Submitted

Initial submission to the registry

September 15, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2028

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 15, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

Pediatric encephalitisAssiutModified Rankin ScaleNeurological outcome

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 30 days

Secondary Outcomes (4)

  • Duration of hospital stay

    Up to 30 days

  • Need for intensive care unit admission

    Up to 30 days

  • Need for nasogastric tube feeding at discharge

    Up to 30 days

  • Nosocomial infections

    Up to 30 days

Study Arms (1)

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.

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20952256BACKGROUND
  • Venkatesan 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.

    PMID: 23861361BACKGROUND
  • Pillai 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.

    PMID: 25802349BACKGROUND

MeSH Terms

Conditions

EncephalitisBrain DiseasesNeurologic Manifestations

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Faisel A Ahmed, prof

    Pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Pediatrics department

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

September 25, 2027

Study Completion (Estimated)

February 25, 2028

Last Updated

September 22, 2026

Record last verified: 2026-09