Epileptic Syndromes in Infants and Early Childhood

NCT06223334 | Recruiting DMC

• 1 other identifier: epilepsy syndromes
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the different clinical and etiological patterns of epileptic syndromes in infants and early childhood.

Conditions

Epileptic Syndromes

Keywords

infants; early childhood

Outcome Measures

Primary Outcomes (1)

• Prevalence of Epileptic syndromes in Infants and early childhood.

  To identify the clinical profile of infants \& children aged 1 to 36 mo and the characteristics of seizures in them during the Child Neurology Outpatients Consults in pediatric neurology units of Al-azhar and Child Assiut University Hospitals. The collected data will be statistically analyzed by statistical package for social sciences (SPSS) version 28 (IBM SPSS Inc., Chicago, US) for Windows 10. Categorical data will be expressed as numbers and percentages while continuous data will be expressed as Mean ± standard deviation (SD). The categorical variables will be compared using chi-square (χ2). The Student's T-test and ANOVA will be used for comparisons in numerical parametric data. P-value will be considered significant if \< 0.05.

  2 years

Secondary Outcomes (1)

• Efficacy of treatment in epileptic syndromes in Infants and early childhood.

  2 years

Study Arms (6)

GTCS (generalized Tonic Clonic Seizures)

Other: No intervention

Tonic Seizures

Other: No intervention

Clonic Seizures

Other: No intervention

Myoclonic Seizures

Other: No intervention

Absence Seizures

Other: No intervention

Focal Seizures

Other: No intervention

Interventions

No intervention OTHER

observational study to evaluate the different clinical and etiological patterns of epileptic syndromes in infants and early childhood.

Absence Seizures; Clonic Seizures; Focal Seizures; GTCS (generalized Tonic Clonic Seizures); Myoclonic Seizures; Tonic Seizures

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The cases will be chosen during the Child Neurology Outpatients Consults in pediatric neurology units of Al-azhar and Child Assiut University Hospitals. Based on clinical data, the patients will be divided into different epilepsy syndromes.

You may qualify if:

• For each group
• Infants and children diagnosed as epilepsy syndrome (as per International League Against Epilepsy, 2014).
• Infants and children ages ranged between 1 \& 36 months.

You may not qualify if:

• for each group
• Patients with epilepsy less than 1 month and more than 36 months.
• Patients with conditions mimic epilepsy.
• Patients with seizures related to electrolyte disturbances, inborn error of metabolism, mitochondrial diseases, white matter diseases, neurodegenerative diseases, peroxisomal disorders and non-syndromic epileptic children.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Assiut child university hospital

Asyut, 71515, Egypt

RECRUITING

AlAzhar university hospital Assiut branch

Asyut, 71524, Egypt

RECRUITING

Related Publications (6)

• Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.

  PMID: 28276062 BACKGROUND

• Farghaly WM, Abd Elhamed MA, Hassan EM, Soliman WT, Yhia MA, Hamdy NA. Prevalence of childhood and adolescence epilepsy in Upper Egypt (desert areas). Egypt J Neurol Psychiatr Neurosurg. 2018;54(1):34. doi: 10.1186/s41983-018-0032-0. Epub 2018 Nov 9.

  PMID: 30532513 BACKGROUND

• Howell KB, Freeman JL, Mackay MT, Fahey MC, Archer J, Berkovic SF, Chan E, Dabscheck G, Eggers S, Hayman M, Holberton J, Hunt RW, Jacobs SE, Kornberg AJ, Leventer RJ, Mandelstam S, McMahon JM, Mefford HC, Panetta J, Riseley J, Rodriguez-Casero V, Ryan MM, Schneider AL, Smith LJ, Stark Z, Wong F, Yiu EM, Scheffer IE, Harvey AS. The severe epilepsy syndromes of infancy: A population-based study. Epilepsia. 2021 Feb;62(2):358-370. doi: 10.1111/epi.16810. Epub 2021 Jan 21.

  PMID: 33475165 BACKGROUND

• Kharod P, Mishra D, Juneja M. Drug-resistant epilepsy in Indian children at a tertiary-care public hospital. Childs Nerv Syst. 2019 May;35(5):775-778. doi: 10.1007/s00381-019-04084-5. Epub 2019 Feb 13.

  PMID: 30758667 BACKGROUND

• Kolc KL, Sadleir LG, Scheffer IE, Ivancevic A, Roberts R, Pham DH, Gecz J. A systematic review and meta-analysis of 271 PCDH19-variant individuals identifies psychiatric comorbidities, and association of seizure onset and disease severity. Mol Psychiatry. 2019 Feb;24(2):241-251. doi: 10.1038/s41380-018-0066-9. Epub 2018 Jun 11.

  PMID: 29892053 BACKGROUND

• Symonds JD, Elliott KS, Shetty J, Armstrong M, Brunklaus A, Cutcutache I, Diver LA, Dorris L, Gardiner S, Jollands A, Joss S, Kirkpatrick M, McLellan A, MacLeod S, O'Regan M, Page M, Pilley E, Pilz DT, Stephen E, Stewart K, Ashrafian H, Knight JC, Zuberi SM. Early childhood epilepsies: epidemiology, classification, aetiology, and socio-economic determinants. Brain. 2021 Oct 22;144(9):2879-2891. doi: 10.1093/brain/awab162.

  PMID: 34687210 BACKGROUND

MeSH Terms

Conditions

Epileptic Syndromes

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Amir Abdelaal Hasanain Abdelrahman

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

• Emad El-Deen Mahmoud Hammad El-Daly

  Assiut University

  STUDY CHAIR

• Mohammed Abo-Alwafa Aladawy

  Al-Azhar University

  STUDY DIRECTOR

Central Study Contacts

Amir Abdelaal Hasanain Abdelrahman

CONTACT

01022086737; dr_amir.makhlof@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 25, 2024
• Study Start: October 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

EG (2)