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NCT Number: NCT06559410

Convulsions in Neonates With Congenital Heart Diseases

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.

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Key information

Conditions

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroencephalogram (EEG), CT Brain, Echocardiogram

Other

analyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures

Primary outcomes

  1. 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

  2. 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

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

    Time frame: baseline

    state if there is any neurological sequalae

Study contacts

Contact information is provided by the study sponsor or research team.

Azhar Arabi Mohammed, Lecturer

CONTACT

[email protected]

+201117862761

Mariam Mohamed Mohamed Abdelhameed

CONTACT

[email protected]

+201008742432

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.