- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07825675
EEG Abnormalities as Predictor of Outcome in Pediatric Encephalopathy
Electroencephalographic (EEG) Abnormalities as a Predictor of Poor Outcome in Pediatric Encephalopathy
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Esraa M Tamer, Resident
- Telefonnummer: +20 11 58780125
- E-post: Esraa.17289969@med.aun.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Poor neurological outcome at hospital discharge
Tidsramme: at 30 days
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of EEG abnormalities
Tidsramme: 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
Tidsramme: at 30 days
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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
Tidsramme: 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
Tidsramme: at 30 days
|
Length of stay in the pediatric intensive care unit in days.
|
at 30 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Gamal A Asker, prof, pediatrics Department, Assiut University Hospitals
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EEG-Encephalopathy-Assiut-2026
Legemiddel- og utstyrsinformasjon, studiedokumenter
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