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Not yet recruiting NCT06559410

Convulsions in Neonates With Congenital Heart Diseases

— Observational Neonatal Convulsion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electroencephalogram (EEG), CT Brain, Echocardiogram.
Who it may be relevant to
Registry conditions: Neonatal Convulsion. Basic parameters: 1 Day — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Electroencephalogram (EEG), CT Brain, Echocardiogram
    analyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures

Primary outcome measures

  • analyze the etiology of seizures in newborns with congenital heart disease [Time frame: baseline]
  • analyze the electroencephalographic (EEG) finding and neuroimaging of newborns with congenital heart disease who were presented with seizures [Time frame: baseline]
  • state neurological sequalae of newborns with congenital heart disease who were presented with seizures [Time frame: baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Glass HC, Wirrell E. Controversies in neonatal seizure management. J Child Neurol. 2009 May;24(5):591-9. doi: 10.1177/0883073808327832. Epub 2009 Feb 13. PMID 19218527
  • Plouin P, Kaminska A. Neonatal seizures. Handb Clin Neurol. 2013;111:467-76. doi: 10.1016/B978-0-444-52891-9.00051-8. PMID 23622196
  • Abend NS, Wusthoff CJ. Neonatal seizures and status epilepticus. J Clin Neurophysiol. 2012 Oct;29(5):441-8. doi: 10.1097/WNP.0b013e31826bd90d. PMID 23027101
  • Jensen FE. Neonatal seizures: an update on mechanisms and management. Clin Perinatol. 2009 Dec;36(4):881-900, vii. doi: 10.1016/j.clp.2009.08.001. PMID 19944840
  • Proposal for revised classification of epilepsies and epileptic syndromes. Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1989 Jul-Aug;30(4):389-99. doi: 10.1111/j.1528-1157.1989.tb05316.x. No abstract available. PMID 2502382
  • Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7. PMID 12084585
  • Samanek M. Congenital heart malformations: prevalence, severity, survival, and quality of life. Cardiol Young. 2000 May;10(3):179-85. doi: 10.1017/s1047951100009082. No abstract available. PMID 10824896
  • Desnous B, Lenoir M, Doussau A, Marandyuk B, Beaulieu-Genest L, Poirier N, Carmant L, Birca A; CINC multidisciplinary team. Epilepsy and seizures in children with congenital heart disease: A prospective study. Seizure. 2019 Jan;64:50-53. doi: 10.1016/j.seizure.2018.11.011. Epub 2018 Nov 26. PMID 30557820

Identifiers

NCT: NCT06559410 · convulsions in neonates

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗