NCT07825675

Brief Summary

This prospective cohort study aims to evaluate the prognostic value of electroencephalographic (EEG) abnormalities in predicting poor clinical outcomes among children with encephalopathy admitted to Assiut University Children Hospital.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
147

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

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

September 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2028

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 9, 2026

Last Update Submit

September 12, 2026

Conditions

Keywords

EEGPediatric encephalopathyPrognosisPCPCNeurological outcomeAssiut

Outcome Measures

Primary Outcomes (1)

  • Poor neurological outcome at hospital discharge

    Proportion of children with poor neurological outcome defined as Pediatric Cerebral Performance Category (PCPC) score ≥3 at hospital discharge.

    at 30 days

Secondary Outcomes (4)

  • Frequency of EEG abnormalities

    Within the first 48 hours of admission

  • Predictive performance of EEG abnormalities for poor outcome

    at 30 days

  • Mortality

    at 30 days

  • Duration of PICU stay

    at 30 days

Study Arms (1)

Single cohort: Children with encephalopathy

Children aged 1 month to 18 years with clinical diagnosis of encephalopathy who will undergo EEG within the first 48 hours of admission and will be assessed for neurological outcome at hospital discharge using the PCPC scale.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children aged 1 month to 18 years admitted with encephalopathy to the Pediatric Intensive Care Unit, Pediatric Neurology Unit, or Emergency Unit of Assiut University Children Hospital.

You may qualify if:

  • Age from 1 month to 18 years
  • Clinical diagnosis of encephalopathy with altered level of consciousness
  • EEG performed within the first 48 hours of admission
  • Written informed consent from parents or legal guardians

You may not qualify if:

  • Neonatal encephalopathy
  • Children with severe pre-existing neurological disability
  • Known epileptic patients
  • Incomplete clinical or EEG data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Abdelrazic MI, Hemeda MS, Abd-Elaziz MA, Mahmoud AR, Abuelela IS. Prevalence and patterns of abnormal metabolic screening in pediatric acute encephalopathy: a PICU study from Egypt. Eur J Pediatr. 2026 Apr 23;185(5):292. doi: 10.1007/s00431-026-06939-x.

    PMID: 42024203BACKGROUND
  • Dempsey LA. Building immune barriers. Nat Immunol. 2025 Apr;26(4):528. doi: 10.1038/s41590-025-02127-5. No abstract available.

    PMID: 40164807BACKGROUND
  • Imataka G, Kuwashima S, Yoshihara S. A Comprehensive Review of Pediatric Acute Encephalopathy. J Clin Med. 2022 Oct 7;11(19):5921. doi: 10.3390/jcm11195921.

    PMID: 36233788BACKGROUND
  • Camargo LL, Rios FJ, Montezano AC, Touyz RM. Reactive oxygen species in hypertension. Nat Rev Cardiol. 2025 Jan;22(1):20-37. doi: 10.1038/s41569-024-01062-6. Epub 2024 Jul 24.

    PMID: 39048744BACKGROUND

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Officials

  • Gamal A Asker, prof

    Pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Esraa M Tamer, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 17, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

March 10, 2028

Last Updated

September 17, 2026

Record last verified: 2026-09