ClinicalTrials.gg
Not yet recruitingNCT07825675Updated Sep 17, 2026

EEG Abnormalities as Predictor of Outcome in Pediatric Encephalopathy

An observational study in Encephalopathy and Brain Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
147
Ages
1 Month to 18 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Encephalopathy
  • Brain Diseases

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Keywords

  • EEG
  • Pediatric encephalopathy
  • Prognosis
  • PCPC
  • Neurological outcome
  • Assiut
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In context

Brain Diseases

502 studies on the registry are indexed under Brain Diseases; 141 are open to participants now.

This study's planned enrollment of 147 is close to the median of 149 across 144 observational studies indexed under Brain Diseases.

Browse Brain Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 from parents or legal guardians

Exclusion criteria

Exclusion Criteria:

  • Neonatal encephalopathy
  • Children with severe pre-existing neurological disability
  • Known epileptic patients
  • Incomplete clinical or EEG data
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
147 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • 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 researchers measure

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.

    Time frame: at 30 days

Secondary outcomes

  1. Frequency of EEG abnormalities

    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.

    Time frame: Within the first 48 hours of admission

  2. Predictive performance of EEG abnormalities for poor outcome

    Sensitivity, specificity, and predictive values of specific EEG abnormalities for poor neurological outcome (PCPC ≥3) at hospital discharge.

    Time frame: at 30 days

  3. Mortality

    Proportion of children who die during hospital stay.

    Time frame: at 30 days

  4. Duration of PICU stay

    Length of stay in the pediatric intensive care unit in days.

    Time frame: at 30 days

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 42024203 ↗
  • Dempsey LA. Building immune barriers. Nat Immunol. 2025 Apr;26(4):528. doi: 10.1038/s41590-025-02127-5. No abstract available. PubMed 40164807 ↗
  • 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. PubMed 36233788 ↗
  • 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. PubMed 39048744 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 78 non-industry observational studies under Brain Diseases, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 193. This study's planned 12 months is below that.

Counting every sponsor, half of 87 studies reached it within 62 months; a quarter within 22 and three quarters within 193.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2026
First posted
Sep 17, 2026
StartEst.
Sep 10, 2026
Primary completionEst.
Sep 10, 2027
CompletionEst.
Mar 10, 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07825675
Lead sponsor
Assiut University
Responsible party
Esraa Mondy Tamer (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 17, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Sep 10, 2027 (estimated)
Completion
Mar 10, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Esraa M Tamer, Resident
Contact
Esraa.17289969@med.aun.edu.eg
+20 11 58780125
Gamal A Asker, prof
study chair · Pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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