EncephalopathyNCT07825675
EEG Abnormalities as Predictor of Outcome in Pediatric Encephalopathy
An observational study of Encephalopathy and Brain Diseases, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Encephalopathy, Brain Diseases
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 10 Mar 2028
- How long will I take part?
- 30 Days
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Neonatal encephalopathy
- Children with severe pre-existing neurological disability
- Known epileptic patients
- Incomplete clinical or EEG data
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: Electroencephalographic (EEG) Abnormalities as a Predictor of Poor Outcome in Pediatric Encephalopathy
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.
- Conditions
- Encephalopathy, Brain Diseases
- Keywords
- EEG, Pediatric encephalopathy, Prognosis, PCPC, Neurological outcome, Assiut
- Medical subject headings
- Brain Diseases
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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 30 days
Secondary outcomes (4)
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.
Measured: Within the first 48 hours of admission
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.
Measured: at 30 days
Mortality
Proportion of children who die during hospital stay.
Measured: at 30 days
Duration of PICU stay
Length of stay in the pediatric intensive care unit in days.
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion10 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EncephalopathyStudies 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
- 147 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mondy Tamer, Assiut University
- Investigators
- Gamal A Asker, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825675
- Sponsor's protocol ID
- EEG-Encephalopathy-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 42024203Dempsey LA. Building immune barriers. Nat Immunol. 2025 Apr;26(4):528. doi: 10.1038/s41590-025-02127-5. No abstract available.
PubMed 40164807Imataka 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 36233788Camargo 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic (EEG) Abnormalities as a Predictor of Poor Outcome in Pediatric Encephalopathy
- ClinicalTrials.gov ID
- NCT07825675
- Acronym / sponsor ID
- EEG-Encephalopathy-Assiut-2026
- Conditions
- Encephalopathy, Brain Diseases
- Keywords
- EEG, Pediatric encephalopathy, Prognosis, PCPC, Neurological outcome, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 10 Mar 2028 (estimated)
- First posted
- 17 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 evaluate the prognostic value of electroencephalographic (EEG) abnormalities in predicting poor clinical outcomes among children with encephalopathy admitted to Assiut University Children Hospital.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Neonatal encephalopathy
- Children with severe pre-existing neurological disability
- Known epileptic patients
- Incomplete clinical or EEG data
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
Poor neurological outcome at hospital discharge
Time frame: at 30 days
Proportion of children with poor neurological outcome defined as Pediatric Cerebral Performance Category (PCPC) score ≥3 at hospital discharge.
4 secondary outcomes
Frequency of EEG abnormalities
Time frame: Within the first 48 hours of admission
Predictive performance of EEG abnormalities for poor outcome
Time frame: at 30 days
Mortality
Time frame: at 30 days
Duration of PICU stay
Time frame: at 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 17 Sep 2026.
- Background: PubMed 42024203Abdelrazic 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.
- Background: PubMed 40164807Dempsey LA. Building immune barriers. Nat Immunol. 2025 Apr;26(4):528. doi: 10.1038/s41590-025-02127-5. No abstract available.
- Background: PubMed 36233788Imataka 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.
- Background: PubMed 39048744Camargo 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.
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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.
Gamal A Asker, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalopathy 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 4 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 17 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 Esraa M Tamer, Resident (+20 11 58780125, Esraa.17289969@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor neurological outcome at hospital discharge (time frame: at 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 NCT07825675, which also lists 4 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 17 Sep 2026.