- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07825675
EEG Abnormalities as Predictor of Outcome in Pediatric Encephalopathy
Electroencephalographic (EEG) Abnormalities as a Predictor of Poor Outcome in Pediatric Encephalopathy
Study Overview
Status
Conditions
Detailed Description
Pediatric encephalopathy has multiple etiologies and variable neurological outcomes. Early prognostic assessment is essential for clinical decision-making and family counseling. Electroencephalography (EEG) is a non-invasive tool that may help predict neurological outcome.
This prospective observational study will include children aged 1 month to 18 years with clinical diagnosis of encephalopathy. EEG will be performed within the first 48 hours of admission. Neurological outcome will be assessed at hospital discharge using the Pediatric Cerebral Performance Category (PCPC) scale. A PCPC score of 1-2 will be considered good outcome and a score of ≥3 will be considered poor outcome.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Esraa M Tamer, Resident
- Phone Number: +20 11 58780125
- Email: Esraa.17289969@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Neonatal encephalopathy
- Children with severe pre-existing neurological disability
- Known epileptic patients
- Incomplete clinical or EEG data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Poor neurological outcome at hospital discharge
Time Frame: at 30 days
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Proportion of children with poor neurological outcome defined as Pediatric Cerebral Performance Category (PCPC) score ≥3 at hospital discharge.
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at 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of EEG abnormalities
Time Frame: Within the first 48 hours of admission
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Proportion of children with specific EEG abnormalities (diffuse background slowing, background suppression, burst suppression, absent reactivity, low-voltage activity, or electrographic seizures) recorded within the first 48 hours of admission.
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Within the first 48 hours of admission
|
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Predictive performance of EEG abnormalities for poor outcome
Time Frame: at 30 days
|
Sensitivity, specificity, and predictive values of specific EEG abnormalities for poor neurological outcome (PCPC ≥3) at hospital discharge.
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at 30 days
|
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Mortality
Time Frame: at 30 days
|
Proportion of children who die during hospital stay.
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at 30 days
|
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Duration of PICU stay
Time Frame: at 30 days
|
Length of stay in the pediatric intensive care unit in days.
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at 30 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gamal A Asker, prof, pediatrics Department, Assiut University Hospitals
Publications and helpful links
General Publications
- 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.
- Dempsey LA. Building immune barriers. Nat Immunol. 2025 Apr;26(4):528. doi: 10.1038/s41590-025-02127-5. No abstract available.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EEG-Encephalopathy-Assiut-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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