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Clinical Trials/NCT06559410
NCT06559410
Not yet recruiting
Not Applicable

A Descriptive Study on Convulsions in Neonates With Congenital Heart Diseases at Assiut University Children Hospital

Assiut University0 sites80 target enrollmentAugust 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Convulsion
Sponsor
Assiut University
Enrollment
80
Primary Endpoint
analyze the electroencephalographic (EEG) finding and neuroimaging of newborns with congenital heart disease who were presented with seizures
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

analyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures during their neonatal intensive care unit admission.

Detailed Description

Neonatal seizures are a commonly encountered neurologic condition in neonates. They are defined as the occurrence of sudden, paroxysmal, abnormal alteration of electrographic activity at any point from birth to the end of the neonatal period. During this period, the neonatal brain is developmentally immature. Thus, neonatal seizures have unique pathophysiology and electrographic findings resulting in clinical manifestations that can be different (and more difficult to identify) when compared to older age groups. Neonatal seizures are paroxysmal, repetitive and stereotypical events. They are usually clinically subtle, inconspicuous and difficult to recognize from the normal behaviors of the inter-ictal periods or physiological phenomena. There is no recognizable post-ictal state. The most widely used scheme is of five main types of neonatal seizure. * Subtle seizures (50%) * Tonic seizures (5%) * Clonic seizures (25%) * Myoclonic seizures (20%) * Non-paroxysmal repetitive behaviors Neonates with congenital heart disease have a high risk of cerebral lesions, seizures, and neurological impairment. By congenital heart disease, we refer to the group of congenital malformations present at birth that include cyanotic as well as non-cyanotic cardiac lesions. Neonatal seizures are the most common clinical expression of central nervous system dysfunction in newborns and one of the most frequent neurological emergencies during this stage of life. They are usually the first sign of neurological involvement and an indicator of the risk of mortality and/ or neurological sequelae.

Registry
clinicaltrials.gov
Start Date
August 10, 2024
End Date
March 31, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mariam Mohamed Mohamed Abdelhameed

Pediatric resident doctor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • All neonates up to 28 days of age with congenital heart diseases presented with repeated seizures admitted to Neonatology unit at Assiut university children hospital

Exclusion Criteria

  • Neonates with normal heart or infants more than 28 days of age.

Outcomes

Primary Outcomes

analyze the electroencephalographic (EEG) finding and neuroimaging of newborns with congenital heart disease who were presented with seizures

Time Frame: baseline

neuroimaging including Brain MSCT

analyze the etiology of seizures in newborns with congenital heart disease

Time Frame: baseline

analyze the etiology of seizures whether it is related to hypoxia, electrolytes disturbances, heart failure or any other casue

state neurological sequalae of newborns with congenital heart disease who were presented with seizures

Time Frame: baseline

state if there is any neurological sequalae

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