Convulsions in Neonates With Congenital Heart Diseases

NCT ID: NCT06559410

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-10

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Neonatal Convulsion

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Mohamed Mohamed Abdelhameed

Pediatric resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mariam Mohamed Mohamed Abdelhameed

Role: CONTACT

+201008742432

Azhar Arabi Mohammed, Lecturer

Role: CONTACT

+201117862761

References

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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.

Reference Type BACKGROUND
PMID: 19218527 (View on PubMed)

Plouin P, Kaminska A. Neonatal seizures. Handb Clin Neurol. 2013;111:467-76. doi: 10.1016/B978-0-444-52891-9.00051-8.

Reference Type BACKGROUND
PMID: 23622196 (View on PubMed)

Abend NS, Wusthoff CJ. Neonatal seizures and status epilepticus. J Clin Neurophysiol. 2012 Oct;29(5):441-8. doi: 10.1097/WNP.0b013e31826bd90d.

Reference Type BACKGROUND
PMID: 23027101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19944840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2502382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12084585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10824896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30557820 (View on PubMed)

Other Identifiers

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convulsions in neonates

Identifier Type: -

Identifier Source: org_study_id

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