Neonatal SeizuresNCT06726655
Patterns of Neonatal Seizures
An observational study of Neonatal Seizures, run by Assiut University.
Trial summary
Study the pattern of neonatal seizures in neonatal intensive care unit at Assiut university children's hospital along year from (Oct.2025-Oct.2026) Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Seizures
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Nov 2026
- 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 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: all neonates comes to Assiut University Hospital with convulsions
Who may be able to join
- Study population comprised of term and preterm newborns who suffered from neonatal seizures.
Who cannot join
- Neoborns presented with non-epileptic behaviors include sucking movements, hiccuping, and benign neonatal sleep myoclonus (physiologic myoclonus that occurs during sleep). Motor automatisms (i.e., repetitive eye-opening, eye deviation, repetitive mouth, and tongue movements, bicycling of the lower extremities, tonic posturing).
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: Patterns of Neonatal Seizures At Assiut University Children's Hospital
Study the pattern of neonatal seizures in neonatal intensive care unit at Assiut university children's hospital along year from (Oct.2025-Oct.2026)
Read the detailed description
Neonatal seizures are a commonly encountered neurologic condition in neonates.[1][2][3] 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[3]. This can be due to excessive excitatory or deficient inhibitory neuronal discharges.[1][4] Due to its immature state, the neonatal brain is prone to seizures due to an imbalance of neuronal excitation over inhibition.[1] The incidence has been reported between 1 to 5.5 per 1000 live births in term infants, with higher incidences reported in preterm infants[5]][6][7].
The classification of neonatal seizure as follows
Subtle Seizures:
They imitate normal behaviours and reactions like the following Ocular movements and Oral-buccal-lingual movements
Motor Seizures:
Clonic seizures are rhythmic jerks that may localise in a small part of the face or limbs, axial muscles and the diaphragm or be multifocal or hemiconvulsive.
Tonic seizures manifest with sustained contraction of facial, limb, axial and other muscles. They may be focal, multifocal or generalised, symmetrical or asymmetrical. Truncal or limb tonic extension imitates decerebrate or decorticate posturing.
Myoclonic seizures are rapid, single or arrhythmic repetitive jerks. They may affect a finger, a limb or the whole body. They may mimic the Moro reflex and startling responses.
Spasms producing flexion or extension similar to those of West syndrome are rare.
Autonomic Ictal Manifestations:
These are paroxysmal changes of heart rate, respiration, systemic blood pressure and apnea[8][9] Management include management of the cause and therapeutic hypothermia for hypoxic-ischemic encephalopathy[10], antibiotics for sepsis/meningitis, providing dextrose if the patient is severely hypoglycemic, correction of electrolyte abnormalities, or referral to neurosurgery if the patient has evidence of an intracranial hemorrhage. If the patient is suspected of having an inborn error of metabolism, halting of feeds, correcting metabolic derangements, and empiric therapy with vitamin and cofactor replacement may be initiated.[6][11][12] If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.[13][14] If seizures do not resolve after the first loading dose, repeat boluses of this medication should be given. The next agent commonly utilized is fosphenytoin.[15] Other agents include levetiracetam and lidocaine in selected settings.[14] Short-acting benzodiazepines (i.e., midazolam) can be utilized if there is a delay in administering these agents.
The prognosis of neonatal seizures depends on the underlying etiology. If EEG is normal the prognosis is excellent but if EEG has many abnormalities such neonates have a poor prognosis and may develop cerebral palsy and epilepsy.The mortality rate of neonatal seizures is reported to be as high as 20%.[13] In survivors, neurologic impairment, disability, developmental delay, and epilepsy are common.[16][17][18][19]
- Conditions
- Neonatal Seizures
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the pattern of neonatal seizures in neonatal intensive care unit at Assiut university children's hospital along year from (Oct.2025-Oct.2026)
Measured: along one year from (Oct.2025-Oct.2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SeizuresStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mamoud Sabra Ahmed Hafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726655
- Sponsor's protocol ID
- Neonatal seizures
- Status last verified
- Oct 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Neonatal Seizures At Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT06726655
- Acronym / sponsor ID
- Neonatal seizures
- Conditions
- Neonatal Seizures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 10 Dec 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.
Study the pattern of neonatal seizures in neonatal intensive care unit at Assiut university children's hospital along year from (Oct.2025-Oct.2026)
Detailed description
Neonatal seizures are a commonly encountered neurologic condition in neonates.[1][2][3] 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[3]. This can be due to excessive excitatory or deficient inhibitory neuronal discharges.[1][4] Due to its immature state, the neonatal brain is prone to seizures due to an imbalance of neuronal excitation over inhibition.[1] The incidence has been reported between 1 to 5.5 per 1000 live births in term infants, with higher incidences reported in preterm infants[5]][6][7].
The classification of neonatal seizure as follows
Subtle Seizures:
They imitate normal behaviours and reactions like the following Ocular movements and Oral-buccal-lingual movements
Motor Seizures:
Clonic seizures are rhythmic jerks that may localise in a small part of the face or limbs, axial muscles and the diaphragm or be multifocal or hemiconvulsive.
Tonic seizures manifest with sustained contraction of facial, limb, axial and other muscles. They may be focal, multifocal or generalised, symmetrical or asymmetrical. Truncal or limb tonic extension imitates decerebrate or decorticate posturing.
Myoclonic seizures are rapid, single or arrhythmic repetitive jerks. They may affect a finger, a limb or the whole body. They may mimic the Moro reflex and startling responses.
Spasms producing flexion or extension similar to those of West syndrome are rare.
Autonomic Ictal Manifestations:
These are paroxysmal changes of heart rate, respiration, systemic blood pressure and apnea[8][9] Management include management of the cause and therapeutic hypothermia for hypoxic-ischemic encephalopathy[10], antibiotics for sepsis/meningitis, providing dextrose if the patient is severely hypoglycemic, correction of electrolyte abnormalities, or referral to neurosurgery if the patient has evidence of an intracranial hemorrhage. If the patient is suspected of having an inborn error of metabolism, halting of feeds, correcting metabolic derangements, and empiric therapy with vitamin and cofactor replacement may be initiated.[6][11][12] If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.[13][14] If seizures do not resolve after the first loading dose, repeat boluses of this medication should be given. The next agent commonly utilized is fosphenytoin.[15] Other agents include levetiracetam and lidocaine in selected settings.[14] Short-acting benzodiazepines (i.e., midazolam) can be utilized if there is a delay in administering these agents.
The prognosis of neonatal seizures depends on the underlying etiology. If EEG is normal the prognosis is excellent but if EEG has many abnormalities such neonates have a poor prognosis and may develop cerebral palsy and epilepsy.The mortality rate of neonatal seizures is reported to be as high as 20%.[13] In survivors, neurologic impairment, disability, developmental delay, and epilepsy are common.[16][17][18][19]
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- all neonates comes to Assiut University Hospital with convulsions
Key inclusion criteria (1 listed)
- Study population comprised of term and preterm newborns who suffered from neonatal seizures.
Key exclusion criteria (1 listed)
- Neoborns presented with non-epileptic behaviors include sucking movements, hiccuping, and benign neonatal sleep myoclonus (physiologic myoclonus that occurs during sleep). Motor automatisms (i.e., repetitive eye-opening, eye deviation, repetitive mouth, and tongue movements, bicycling of the lower extremities, tonic posturing).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study the pattern of neonatal seizures in neonatal intensive care unit at Assiut university children's hospital along year from (Oct.2025-Oct.2026)
Time frame: along one year from (Oct.2025-Oct.2026)
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 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Early Check: Expanded Screening in Newborns
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Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy
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Treatment of Seizures in Neonate With HIE
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Not yet recruitingObservational study
Clinical Profile And Outcomes Of Neonatal Convulsions In The Neonatal Intensive Care Unit At Assiut University Children's Hospital
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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 Seizures, 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: opening soon, as of the sponsor's last update on 10 Dec 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?
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 Mahmoud Sabra Ahmed Hafez (+021098204095, mahmoudsabraaaaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the pattern of neonatal seizures in neonatal intensive care unit at Assiut university children's hospital along year from (Oct.2025-Oct.2026) (time frame: along one year from (Oct.2025-Oct.2026)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2024; AzTrials last refreshed its copy on 31 Oct 2026.