Clinical trial NCT06559410: Convulsions in Neonates With Congenital Heart Diseases
Official title: A Descriptive Study on Convulsions in Neonates With Congenital Heart Diseases at Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Convulsion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonates with congenital heart diseases

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.

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.

Primary outcomes:
measure: analyze the etiology of seizures in newborns with congenital heart disease
timeFrame: baseline
measure: analyze the electroencephalographic (EEG) finding and neuroimaging of newborns with congenital heart disease who were presented with seizures
timeFrame: baseline
measure: state neurological sequalae of newborns with congenital heart disease who were presented with seizures
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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