Epileptic Syndromes in Infants and Early Childhood

February 27, 2024 updated by: Amir Abdelaal Hasanain Abdelrahman, Al-Azhar University

Clinico-etiological Profile of Epileptic Syndromes in Infants and Early Childhood

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Epilepsy is the most common disabling neurological problem among children worldwide, and has a varying prevalence and etiological profile across the life-cycle. Onset of epilepsy prior to two-year age is more common than later in childhood.

It more commonly has a symptomatic cause and poor long-term outcome with respect to seizure-control and cognition. Previous work from India on epilepsy in infants has either focused on a single etiology, on one particular epilepsy syndrome, or on single seizure rather than epilepsy.

A recent prospective, population-based study showed an incidence of 75 per 100 000 live births prior to 6 months and 62 per 100 000 between 6 and 12 months, considerably higher than previous estimates from retrospective studies. These population-based studies are from high-resource countries, and it is noteworthy that acquired epilepsies have a higher incidence in resource-limited populations.

Traditionally, syndromes have been defined primarily by electroclinical features; however, in the last two decades, gene discovery in the epilepsies has allowed cohorts of cases with a shared genetic etiology to be studied. Consistent electroclinical phenotypes have emerged, with examples including CDKL5, MeCP2, PCDH19, STXBP1, and inv dup 15.

An epileptic syndrome is "an epileptic disorder characterised by a cluster of signs and symptoms customarily occurring together; these include such items as the type of seizure, aetiology, anatomy, precipitating factors, age of onset, severity, chronicity, diurnal and circadian cycling, and sometimes prognosis. However, in contradistinction to a disease, a syndrome does not necessarily have a common aetiology and prognosis.

An epilepsy syndrome is "a complex of signs and symptoms that define a unique epilepsy condition. This must involve more than just the seizure type; thus, for instance, frontal lobe seizures per se do not constitute a syndrome.

Furthermore, some structural, metabolic, immune, and infectious etiologies also have characteristic electroclinical phenotypes. Therefore, epilepsies due to specific genetic, structural, metabolic, immune, or infectious etiologies may also meet criteria for a syndrome, when they are associated with consistent electroclinical features and have management and prognostic implications. Epilepsies in children younger than 3-years-old can be classified by syndrome in 54% of patients and by etiology in 54%, when the latest neuroimaging, metabolic, and gene testing techniques are used. In the group younger than 12 months, etiology could be determined in 64%. By comparison, infants with severe epilepsies beginning before 18 months can be classified with an epilepsy syndrome at presentation in 64%, with the etiology being determined in 67%.

The concept of the "developmental and epileptic encephalopathy" (or DEE) recognizes that in infants presenting with severe early-onset epilepsy, neurodevelopmental comorbidity may be attributable to both the underlying cause and to the adverse effects of uncontrolled epileptic activity.

Children presenting with epilepsy very early in life experience a high burden of cognitive and behavioral comorbidity, and higher rates of drug resistance and mortality, with up to 50% showing global developmental delay 2 years after presentation. Comorbidities are more frequent among children who develop drug-resistant seizures and those with a high seizure burden.

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
      • Assiut, Egypt, 71524
        • Recruiting
        • AlAzhar university hospital Assiut branch
        • Contact:
          • Faculty of Medicine-AlAzhar University Assiut branch
          • Phone Number: 002 (088)2180445
          • Email: med.ast.b@azhar.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GTCS (generalized Tonic Clonic Seizures)
Other: No intervention
observational study to evaluate the different clinical and etiological patterns of epileptic syndromes in infants and early childhood.
Tonic Seizures
Other: No intervention
observational study to evaluate the different clinical and etiological patterns of epileptic syndromes in infants and early childhood.
Clonic Seizures
Other: No intervention
observational study to evaluate the different clinical and etiological patterns of epileptic syndromes in infants and early childhood.
Myoclonic Seizures
Other: No intervention
observational study to evaluate the different clinical and etiological patterns of epileptic syndromes in infants and early childhood.
Absence Seizures
Other: No intervention
observational study to evaluate the different clinical and etiological patterns of epileptic syndromes in infants and early childhood.
Focal Seizures
Other: No intervention
observational study to evaluate the different clinical and etiological patterns of epileptic syndromes in infants and early childhood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Epileptic syndromes in Infants and early childhood.
Time Frame: 2 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of treatment in epileptic syndromes in Infants and early childhood.
Time Frame: 2 years
Clinical improvement will be calculated by dividing improved patients by the number of enrolled patients in each group (calculated as intended to treat and per protocol analysis). Effect size using odds ratios (with their confidence intervals, CI) of improved and not improved patients.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Amir Abdelaal Hasanain Abdelrahman, Alazhar University
  • Study Chair: Emad El-Deen Mahmoud Hammad El-Daly, Assiut University
  • Study Director: Mohammed Abo-Alwafa Aladawy, Alazhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • epilepsy syndromes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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