- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07825675
EEG Abnormalities as Predictor of Outcome in Pediatric Encephalopathy
Electroencephalographic (EEG) Abnormalities as a Predictor of Poor Outcome in Pediatric Encephalopathy
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Esraa M Tamer, Resident
- Telefonnummer: +20 11 58780125
- E-post: Esraa.17289969@med.aun.edu.eg
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Poor neurological outcome at hospital discharge
Tidsram: at 30 days
|
Proportion of children with poor neurological outcome defined as Pediatric Cerebral Performance Category (PCPC) score ≥3 at hospital discharge.
|
at 30 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frequency of EEG abnormalities
Tidsram: Within the first 48 hours of admission
|
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.
|
Within the first 48 hours of admission
|
|
Predictive performance of EEG abnormalities for poor outcome
Tidsram: at 30 days
|
Sensitivity, specificity, and predictive values of specific EEG abnormalities for poor neurological outcome (PCPC ≥3) at hospital discharge.
|
at 30 days
|
|
Mortality
Tidsram: at 30 days
|
Proportion of children who die during hospital stay.
|
at 30 days
|
|
Duration of PICU stay
Tidsram: at 30 days
|
Length of stay in the pediatric intensive care unit in days.
|
at 30 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Gamal A Asker, prof, pediatrics Department, Assiut University Hospitals
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EEG-Encephalopathy-Assiut-2026
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