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Neonatal SeizuresNCT06726655

Patterns of Neonatal Seizures

An observational study of Neonatal Seizures, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Mahmoud Sabra Ahmed Hafez contact

+021098204095

mahmoudsabraaaaa@gmail.com

Nafisa Hassan Reffat contact

+021003472082

nafisarafat@gmail.com

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]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted10 Dec 2024
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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)
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

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.

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