Neonatal ConvulsionNCT06559410
Convulsions in Neonates With Congenital Heart Diseases
An observational study of Neonatal Convulsion, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Convulsion
- What is being tested?
- Electroencephalogram (EEG), CT Brain, Echocardiogram
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Child
Study population: neonates with congenital heart diseases
Who may be able to join
- 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
Who cannot join
- Neonates with normal heart or infants more than 28 days of age.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Descriptive Study on Convulsions in Neonates With Congenital Heart Diseases at Assiut University Children Hospital
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.
Read the 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.
- Conditions
- Neonatal Convulsion
- Being tested
- Electroencephalogram (EEG), CT Brain, Echocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram (EEG), CT Brain, EchocardiogramOther
analyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures
What is being measured
The primary outcome is the main question the study is designed to answer.
analyze the etiology of seizures in newborns with congenital heart disease
analyze the etiology of seizures whether it is related to hypoxia, electrolytes disturbances, heart failure or any other casue
Measured: baseline
analyze the electroencephalographic (EEG) finding and neuroimaging of newborns with congenital heart disease who were presented with seizures
neuroimaging including Brain MSCT
Measured: baseline
state neurological sequalae of newborns with congenital heart disease who were presented with seizures
state if there is any neurological sequalae
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neonatal ConvulsionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Mohamed Abdelhameed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559410
- Sponsor's protocol ID
- convulsions in neonates
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 19218527Plouin P, Kaminska A. Neonatal seizures. Handb Clin Neurol. 2013;111:467-76. doi: 10.1016/B978-0-444-52891-9.00051-8.
PubMed 23622196Abend NS, Wusthoff CJ. Neonatal seizures and status epilepticus. J Clin Neurophysiol. 2012 Oct;29(5):441-8. doi: 10.1097/WNP.0b013e31826bd90d.
PubMed 23027101Jensen 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.
PubMed 19944840Proposal 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.
PubMed 2502382Hoffman 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.
PubMed 12084585Samanek 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.
PubMed 10824896Desnous 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.
PubMed 30557820
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study on Convulsions in Neonates With Congenital Heart Diseases at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06559410
- Acronym / sponsor ID
- convulsions in neonates
- Conditions
- Neonatal Convulsion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- neonates with congenital heart diseases
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Neonates with normal heart or infants more than 28 days of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroencephalogram (EEG), CT Brain, Echocardiogramanalyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures | Other | – |
Primary outcome
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
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
state neurological sequalae of newborns with congenital heart disease who were presented with seizures
Time frame: baseline
state if there is any neurological sequalae
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 19218527Glass 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.
- Background: PubMed 23622196Plouin P, Kaminska A. Neonatal seizures. Handb Clin Neurol. 2013;111:467-76. doi: 10.1016/B978-0-444-52891-9.00051-8.
- Background: PubMed 23027101Abend NS, Wusthoff CJ. Neonatal seizures and status epilepticus. J Clin Neurophysiol. 2012 Oct;29(5):441-8. doi: 10.1097/WNP.0b013e31826bd90d.
- Background: PubMed 19944840Jensen 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.
- Background: PubMed 2502382Proposal 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.
- Background: PubMed 12084585Hoffman 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.
- Background: PubMed 10824896Samanek 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.
- Background: PubMed 30557820Desnous 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Convulsion, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Mohamed Mohamed Abdelhameed (+201008742432, Mariam.16266047@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analyze the etiology of seizures in newborns with congenital heart disease (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06559410, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.