Neonatal ConvulsionsNCT07274410
Clinical Profile And Outcomes Of Neonatal Convulsions In The Neonatal Intensive Care Unit At Assiut University Children's Hospital
An observational study of Neonatal Convulsions and Newborn Seizure Disorders, run by Assiut University.
Trial summary
Neonatal convulsions are seizures that occur during the first 28 days of a newborn's life. They are considered a medical emergency and often indicate an underlying problem in the brain, such as lack of oxygen at birth, infections, metabolic disturbances, or structural abnormalities. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Neonatal Convulsions, Newborn Seizure Disorders, Seizures
- What is being tested?
- Management of Neonatal Convulsions
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 days
- All sexes
- No healthy volunteers
- Child
Study population: The study population includes neonates aged 0 to 30 days admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children's Hospital who are diagnosed with neonatal convulsions. Both full-term and preterm infants of either sex will be included. Neonates with conditions mimicking seizures (e.g., jitteriness, benign neonatal sleep myoclonus, motor automatisms, hyperekplexia, Sandifer syndrome) will be excluded. The target population is expected to be representative of neonates admitted to the NICU with convulsions during the study period from March 2024 to August 2025.
Who may be able to join
- Children aged between 0 to 30day.
- Children diagnosed with neonatal seizures
- All newborn fullterm,preterm.males and females with neonatal convulsions.
Who cannot join
- Children above age of 30 day and those with mimic condition as
- jitteriness, benign neonatal sleep myoclonus, motor automatisms,
- hyperekplexia, and Sandifer syndrome..
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Profile And Outcome Of Neonatal Convulsions Among Newborns Admitted To The Neonatal Intensive Care Unit At Assiut University Children's Hospital: A Prospective Cohort Study
Neonatal convulsions are seizures that occur during the first 28 days of a newborn's life. They are considered a medical emergency and often indicate an underlying problem in the brain, such as lack of oxygen at birth, infections, metabolic disturbances, or structural abnormalities. Many seizures in newborns are subtle and difficult to detect without careful clinical assessment.
This study aims to determine how often neonatal convulsions occur among newborns admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children Hospital. It will describe how affected newborns present clinically, identify the main causes, and evaluate the early outcomes during hospitalization.
Read more
The study is designed as a prospective cohort study. Newborns aged 0-30 days who are diagnosed with neonatal convulsions will be enrolled and followed throughout their stay in the NICU. Each patient will undergo full clinical evaluation and standard laboratory and imaging investigations, including blood tests, neuroimaging, and other tests as clinically indicated.
The findings of this study will provide updated local data on the incidence, causes, and outcomes of neonatal convulsions in our region. This information may help improve early diagnosis, guide appropriate treatment, and enhance the quality of neonatal care.
Read the detailed description
Neonatal convulsions represent one of the most important neurological emergencies in early life and are strongly associated with underlying brain dysfunction. In many cases, the clinical manifestations are subtle, making diagnosis challenging without careful observation and appropriate diagnostic tools. Early recognition of neonatal seizures and identification of their etiologies play essential roles in preventing long-term neurological complications.
This prospective cohort study is designed to investigate the clinical profile and outcomes of neonatal convulsions among newborns admitted to the Neonatal Intensive Care Unit at Assiut University Children Hospital. The study will include newborns aged 0 to 30 days, of both sexes, who are clinically diagnosed with neonatal convulsions. Exclusion criteria include infants older than 30 days or those with movement disorders that mimic seizures, such as jitteriness, benign neonatal sleep myoclonus, hyperekplexia, motor automatisms, or Sandifer syndrome.
After obtaining informed consent from parents or caregivers, enrolled neonates will undergo a comprehensive assessment that includes detailed maternal and perinatal history, physical examination, neurological evaluation, and documentation of seizure semiology. Laboratory investigations include complete blood count, renal and liver function tests, serum electrolytes, blood glucose, metabolic screening when indicated, and infection workup. Neuroimaging such as cranial ultrasound, CT scan, or MRI will be performed based on clinical indications. Additional investigations such as EEG may be used as available.
The primary outcome is to determine the rate of neonatal convulsions among NICU admissions. Secondary outcomes include identification of the most common etiologies, description of clinical patterns, response to treatment, and early in-hospital outcomes such as seizure control, complications, and duration of NICU stay.
Data will be analyzed using standard statistical methods to generate descriptive and analytic comparisons. Findings from this study are expected to fill important knowledge gaps in the local epidemiology of neonatal convulsions and provide evidence to improve diagnostic strategies, early intervention, and quality of neonatal care.
- Conditions
- Neonatal Convulsions, Newborn Seizure Disorders, Seizures
- Being tested
- Management of Neonatal Convulsions
- Keywords
- Neonatal convulsions, Neonatal ICU, outcomes
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of Neonatal ConvulsionsOther
This intervention involves the clinical management of neonatal convulsions in newborns aged 0-30 days admitted to the NICU. Management includes prompt identification of seizure activity through clinical evaluation and EEG confirmation, followed by appropriate treatment using anticonvulsant medications such as phenobarbital. Supportive care includes monitoring of vital signs, glucose, and electrolytes, and performing necessary investigations like abdominal ultrasound, echocardiography, and brain imaging (MRI/CT) to identify underlying causes. The intervention aims to control seizures, minimize neurological complications, and improve short-term and long-term outcomes in affected neonates.
| Study group | Role | What they receive |
|---|---|---|
| Neonatal Convulsions | This cohort includes neonates aged 0-30 days who are admitted to the Neonatal Intensive Care Unit at Assiut University Children's Hospital and diagnosed with neonatal convulsions. Participants will undergo clinical evaluation, laboratory investigations, neuroimaging, and follow-up to assess seizure characteristics, underlying etiologies, management, and outcomes. No interventions will be assigned; only observational data will be collected. Receives: Other: Management of Neonatal Convulsions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of neonatal convulsions in newborns admitted to the NICU
The proportion of neonates diagnosed with convulsions confirmed clinically and by EEG during hospitalization in the neonatal intensive care unit.
Measured: During NICU stay (up to 30 days of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal ConvulsionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zeinab ahmed abdel sabour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274410
- Sponsor's protocol ID
- NC-ASSIUT-2024
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beniczky S, Tatum WO, Blumenfeld H, Stefan H, Mani J, Maillard L, Fahoum F, Vinayan KP, Mayor LC, Vlachou M, Seeck M, Ryvlin P, Kahane P. Seizure semiology: ILAE glossary of terms and their significance. Epileptic Disord. 2022 Jun 1;24(3):447-495. doi: 10.1684/epd.2022.1430.
PubMed 35770761Specchio N, Wirrell EC, Scheffer IE, Nabbout R, Riney K, Samia P, Guerreiro M, Gwer S, Zuberi SM, Wilmshurst JM, Yozawitz E, Pressler R, Hirsch E, Wiebe S, Cross HJ, Perucca E, Moshe SL, Tinuper P, Auvin S. International League Against Epilepsy classification and definition of epilepsy syndromes with onset in childhood: Position paper by the ILAE Task Force on Nosology and Definitions. Epilepsia. 2022 Jun;63(6):1398-1442. doi: 10.1111/epi.17241. Epub 2022 May 3.
PubMed 35503717Kim EH, Shin J, Lee BK. Neonatal seizures: diagnostic updates based on new definition and classification. Clin Exp Pediatr. 2022 Aug;65(8):387-397. doi: 10.3345/cep.2021.01361. Epub 2022 Apr 4.
PubMed 35381171Shellhaas RA. Neonatal seizures reach the mainstream: The ILAE classification of seizures in the neonate. Epilepsia. 2021 Mar;62(3):629-631. doi: 10.1111/epi.16857. Epub 2021 Feb 26. No abstract available.
PubMed 33634848
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile And Outcome Of Neonatal Convulsions Among Newborns Admitted To The Neonatal Intensive Care Unit At Assiut University Children's Hospital: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07274410
- Acronym / sponsor ID
- NC-ASSIUT-2024
- Conditions
- Neonatal Convulsions, Newborn Seizure Disorders, Seizures
- Keywords
- Neonatal convulsions, Neonatal ICU, outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Dec 2025 (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.
Neonatal convulsions are seizures that occur during the first 28 days of a newborn's life. They are considered a medical emergency and often indicate an underlying problem in the brain, such as lack of oxygen at birth, infections, metabolic disturbances, or structural abnormalities. Many seizures in newborns are subtle and difficult to detect without careful clinical assessment.
This study aims to determine how often neonatal convulsions occur among newborns admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children Hospital. It will describe how affected newborns present clinically, identify the main causes, and evaluate the early outcomes during hospitalization.
The study is designed as a prospective cohort study. Newborns aged 0-30 days who are diagnosed with neonatal convulsions will be enrolled and followed throughout their stay in the NICU. Each patient will undergo full clinical evaluation and standard laboratory and imaging investigations, including blood tests, neuroimaging, and other tests as clinically indicated.
The findings of this study will provide updated local data on the incidence, causes, and outcomes of neonatal convulsions in our region. This information may help improve early diagnosis, guide appropriate treatment, and enhance the quality of neonatal care.
Detailed description
Neonatal convulsions represent one of the most important neurological emergencies in early life and are strongly associated with underlying brain dysfunction. In many cases, the clinical manifestations are subtle, making diagnosis challenging without careful observation and appropriate diagnostic tools. Early recognition of neonatal seizures and identification of their etiologies play essential roles in preventing long-term neurological complications.
This prospective cohort study is designed to investigate the clinical profile and outcomes of neonatal convulsions among newborns admitted to the Neonatal Intensive Care Unit at Assiut University Children Hospital. The study will include newborns aged 0 to 30 days, of both sexes, who are clinically diagnosed with neonatal convulsions. Exclusion criteria include infants older than 30 days or those with movement disorders that mimic seizures, such as jitteriness, benign neonatal sleep myoclonus, hyperekplexia, motor automatisms, or Sandifer syndrome.
After obtaining informed consent from parents or caregivers, enrolled neonates will undergo a comprehensive assessment that includes detailed maternal and perinatal history, physical examination, neurological evaluation, and documentation of seizure semiology. Laboratory investigations include complete blood count, renal and liver function tests, serum electrolytes, blood glucose, metabolic screening when indicated, and infection workup. Neuroimaging such as cranial ultrasound, CT scan, or MRI will be performed based on clinical indications. Additional investigations such as EEG may be used as available.
The primary outcome is to determine the rate of neonatal convulsions among NICU admissions. Secondary outcomes include identification of the most common etiologies, description of clinical patterns, response to treatment, and early in-hospital outcomes such as seizure control, complications, and duration of NICU stay.
Data will be analyzed using standard statistical methods to generate descriptive and analytic comparisons. Findings from this study are expected to fill important knowledge gaps in the local epidemiology of neonatal convulsions and provide evidence to improve diagnostic strategies, early intervention, and quality of neonatal care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal Convulsions | – | Other: Management of Neonatal ConvulsionsThis cohort includes neonates aged 0-30 days who are admitted to the Neonatal Intensive Care Unit at Assiut University Children's Hospital and diagnosed with neonatal convulsions. Participants will undergo clinical evaluation, laboratory investigations, neuroimaging, and follow-up to assess seizure characteristics, underlying etiologies, management, and outcomes. No interventions will be assigned; only observational data will be collected. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population includes neonates aged 0 to 30 days admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children's Hospital who are diagnosed with neonatal convulsions. Both full-term and preterm infants of either sex will be included. Neonates with conditions mimicking seizures (e.g., jitteriness, benign neonatal sleep myoclonus, motor automatisms, hyperekplexia, Sandifer syndrome) will be excluded. The target population is expected to be representative of neonates admitted to the NICU with convulsions during the study period from March 2024 to August 2025.
Key inclusion criteria (3 listed)
- Children aged between 0 to 30day.
- Children diagnosed with neonatal seizures
- All newborn fullterm,preterm.males and females with neonatal convulsions.
Key exclusion criteria (3 listed)
- Children above age of 30 day and those with mimic condition as
- jitteriness, benign neonatal sleep myoclonus, motor automatisms,
- hyperekplexia, and Sandifer syndrome..
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 |
|---|---|---|
| Management of Neonatal ConvulsionsThis intervention involves the clinical management of neonatal convulsions in newborns aged 0-30 days admitted to the NICU. Management includes prompt identification of seizure activity through clinical evaluation and EEG confirmation, followed by appropriate treatment using anticonvulsant medications such as phenobarbital. Supportive care includes monitoring of vital signs, glucose, and electrolytes, and performing necessary investigations like abdominal ultrasound, echocardiography, and brain imaging (MRI/CT) to identify underlying causes. The intervention aims to control seizures, minimize neurological complications, and improve short-term and long-term outcomes in affected neonates. | Other | Neonatal Convulsions |
Primary outcome
Rate of neonatal convulsions in newborns admitted to the NICU
Time frame: During NICU stay (up to 30 days of age)
The proportion of neonates diagnosed with convulsions confirmed clinically and by EEG during hospitalization in the neonatal intensive care unit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 35770761Beniczky S, Tatum WO, Blumenfeld H, Stefan H, Mani J, Maillard L, Fahoum F, Vinayan KP, Mayor LC, Vlachou M, Seeck M, Ryvlin P, Kahane P. Seizure semiology: ILAE glossary of terms and their significance. Epileptic Disord. 2022 Jun 1;24(3):447-495. doi: 10.1684/epd.2022.1430.
- Results publication: PubMed 35503717Specchio N, Wirrell EC, Scheffer IE, Nabbout R, Riney K, Samia P, Guerreiro M, Gwer S, Zuberi SM, Wilmshurst JM, Yozawitz E, Pressler R, Hirsch E, Wiebe S, Cross HJ, Perucca E, Moshe SL, Tinuper P, Auvin S. International League Against Epilepsy classification and definition of epilepsy syndromes with onset in childhood: Position paper by the ILAE Task Force on Nosology and Definitions. Epilepsia. 2022 Jun;63(6):1398-1442. doi: 10.1111/epi.17241. Epub 2022 May 3.
- Results publication: PubMed 35381171Kim EH, Shin J, Lee BK. Neonatal seizures: diagnostic updates based on new definition and classification. Clin Exp Pediatr. 2022 Aug;65(8):387-397. doi: 10.3345/cep.2021.01361. Epub 2022 Apr 4.
- Results publication: PubMed 33634848Shellhaas RA. Neonatal seizures reach the mainstream: The ILAE classification of seizures in the neonate. Epilepsia. 2021 Mar;62(3):629-631. doi: 10.1111/epi.16857. Epub 2021 Feb 26. No abstract available.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Convulsions and Newborn Seizure Disorders, 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zeinab ahmed abdel sabour, resident (01004231328, Zeinab.15235539@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of neonatal convulsions in newborns admitted to the NICU (time frame: During NICU stay (up to 30 days of age)). 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 NCT07274410, which also lists 4 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 10 Dec 2025.