- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06726655
Patterns of Neonatal Seizures
Patterns of Neonatal Seizures At Assiut University Children's Hospital
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mahmoud Sabra Ahmed Hafez
- Phone Number: +021098204095
- Email: mahmoudsabraaaaa@gmail.com
Study Contact Backup
- Name: Nafisa Hassan Reffat
- Phone Number: +021003472082
- Email: nafisarafat@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
Study population comprised of term and preterm newborns who suffered from neonatal seizures.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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)
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along one year from (Oct.2025-Oct.2026)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neonatal seizures
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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Stephanie Merhar, MDTerminated
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Great Ormond Street Hospital for Children NHS Foundation...Karolinska University Hospital; University College London Hospitals; Helsinki... and other collaboratorsCompletedNeonatal SeizuresUnited Kingdom, Sweden, Ireland, Netherlands