Neonatal ConvulsionNCT06181383
Phenobarbital Versus Levetiracetam Neonatal Convulsion
An observational study of Neonatal Convulsion, run by Assiut University.
Trial summary
If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.(Glass et al;2016) ,Its mechanism of action is the synaptic inhibition through an action on GABA receptors, It can not only control seizures but also reduce the metabolism of the brain .(Geneva;2011)… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Convulsion
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2023to 30 May 2025
- 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 present with Convulsions
Who may be able to join
- All neonates with convulsions.
Who cannot join
- 1.Convulsions that occur beyond neonatal period. 2.Secondary neonatal convulsions eg: hypoglycemic, hypocalcemic, hypomagnesemic convalsions.
About this study
If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.(Glass et al;2016) ,Its mechanism of action is the synaptic inhibition through an action on GABA receptors, It can not only control seizures but also reduce the metabolism of the brain .(Geneva;2011) ,Phenobarbital can control 43-80% of electrical seizures (abnormal electroencephalograms) in newborns.(Sharpe et al;2020) Levetiracetam can also be used for treatment of neonatal seizures, which is safer than phenobarbital, it's mechanism of action is modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain, with less side effects on cognitive development in the levetiracetam treated subjects.(maigre et al;2013)
Read the detailed description
Neonatal seizures are a commonly encountered neurologic condition in neonates.(GlassHC; 2014) 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.(Abend\&wusthoff;2012)
Diagnoses that require priority evaluation and urgent treatment are categorized as follows:
- Metabolic disturbances (soul;2018) as Hypoglycemia, (Hall et al;2006) ,Hypocalcemia , (Nardone et al.;2016)
- Hypoxic conditions,( Glass et al;2016) :Hypoxic-ischemic encephalopathy ,Perinatal asphyxia
- Intracranial hemorrhage :(Intraventricular,Intraparenchymal,Subarachnoid ,Subdural)
- Infection :as Bacterial meningitis (Group B Streptococcus, Escherichia coli, Listeria monocytogenes)(ku at al;2015)
- Inborn errors of metabolism - selected enzyme deficiencies :as Urea cycle defects(Yu \&pearl;2013), vitamin and cofactor deficiencies: as Pyroxidine deficiency.
- Thromboembolic: as Arterial ischemic stroke.(Govaert et al;2009) The incidence of Neonatal seizures has been reported between 1 to 5.5 per 1000 live births in term infants, with higher incidences reported in preterm infants.(Orivoli et al ;2015)
The classification of neonatal seizure types and their significant features are as follows:
- Focal clonic seizures(Volp;1989) :Manifests as repetitive rhythmic contractions ,It can involve the face, upper or lower extremities, neck, or trunk,It cannot be extinguished by the physical suppression of movement or limb repositioning ,May migrate to other areas of the body within the same seizure (most commonly contralaterally but can occur ipsilaterally as well),If generalized, the seizure activity is diffuse, bilateral, and synchronous
- Focal tonic seizures :Manifests as a continuous but transient extremity posturing or asymmetric posturing of the trunk or neck ,May include horizontal eye deviation ,If generalized, may mimic decerebrate posturing (upper and lower extremity tonic extension) or decorticate posturing (upper extremity flexion and lower extremity extension)
- Myoclonic seizures(Sharma et al;2014) :Manifests as nonrepetitive contractions ,Involves flexor muscle groups of the extremity (commonly upper extremity), trunk, diaphragm, or face ,If generalized, the seizures may appear as bilateral jerking of the flexor muscles of the upper and lower extremities.
- Subtle (unspecified) seizure is the most common type of convulsion. It includes movements such as a tremor in the eyelids; a fixed gaze in the eyes or horizontal deviation; smacking, chewing, or other oral movements; and pedaling gestures. Autonomic findings such as tachycardia andhypotension often accompany these findings.
Treatment / Management :After ensuring the patient has a patent airway, is hemodynamically stable, and has intravenous access, therapy should be targeted to treat the underlying condition identified. This can include therapeutic hypothermia for hypoxic-ischemic encephalopathy, (Papile et al ;2014) 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(Sharma\&Prasad;2017) If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.(Glass et al;2016) ,Its mechanism of action is the synaptic inhibition through an action on GABA receptors, It can not only control seizures but also reduce the metabolism of the brain .(Geneva;2011) ,Phenobarbital can control 43-80% of electrical seizures (abnormal electroencephalograms) in newborns.(Sharpe et al;2020) Levetiracetam can also be used for treatment of neonatal seizures, which is safer than phenobarbital, it's mechanism of action is modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain, with less side effects on cognitive development in the levetiracetam treated subjects.(Maitre et al;2013)
- Conditions
- Neonatal Convulsion
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attacks
Phenobarbital versus levetracetam (Efficacy and safety ) in treatment of neonatal convulsion
Measured: baseline
Incidence of Possible side effects of both drugs include
Possible side effects of both drugs include:
- Hypotension
- Bradycardia
- Respiratory abnormalities
- Sedation
- Irritability
- Poor feeding
- Need of oxygen, mechanical ventilation or vasopressor medication
- Apnea
- Hypersensitivity reaction (angioedema, skin rash)
- Bleeding (per gum, nose, urine)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start30 Dec 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashwa Nasser Heshmat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181383
- Sponsor's protocol ID
- Phenobarbital & levetiracetam
- Status last verified
- Dec 2023
- First submitted
- 26 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenobarbital Versus Levetiracetam Neonatal Convulsion
- ClinicalTrials.gov ID
- NCT06181383
- Acronym / sponsor ID
- Phenobarbital & levetiracetam
- Conditions
- Neonatal Convulsion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 26 Dec 2023 (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.
If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.(Glass et al;2016) ,Its mechanism of action is the synaptic inhibition through an action on GABA receptors, It can not only control seizures but also reduce the metabolism of the brain .(Geneva;2011) ,Phenobarbital can control 43-80% of electrical seizures (abnormal electroencephalograms) in newborns.(Sharpe et al;2020) Levetiracetam can also be used for treatment of neonatal seizures, which is safer than phenobarbital, it's mechanism of action is modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain, with less side effects on cognitive development in the levetiracetam treated subjects.(maigre et al;2013)
Detailed description
Neonatal seizures are a commonly encountered neurologic condition in neonates.(GlassHC; 2014) 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.(Abend\&wusthoff;2012)
Diagnoses that require priority evaluation and urgent treatment are categorized as follows:
- Metabolic disturbances (soul;2018) as Hypoglycemia, (Hall et al;2006) ,Hypocalcemia , (Nardone et al.;2016)
- Hypoxic conditions,( Glass et al;2016) :Hypoxic-ischemic encephalopathy ,Perinatal asphyxia
- Intracranial hemorrhage :(Intraventricular,Intraparenchymal,Subarachnoid ,Subdural)
- Infection :as Bacterial meningitis (Group B Streptococcus, Escherichia coli, Listeria monocytogenes)(ku at al;2015)
- Inborn errors of metabolism - selected enzyme deficiencies :as Urea cycle defects(Yu \&pearl;2013), vitamin and cofactor deficiencies: as Pyroxidine deficiency.
- Thromboembolic: as Arterial ischemic stroke.(Govaert et al;2009) The incidence of Neonatal seizures has been reported between 1 to 5.5 per 1000 live births in term infants, with higher incidences reported in preterm infants.(Orivoli et al ;2015)
The classification of neonatal seizure types and their significant features are as follows:
- Focal clonic seizures(Volp;1989) :Manifests as repetitive rhythmic contractions ,It can involve the face, upper or lower extremities, neck, or trunk,It cannot be extinguished by the physical suppression of movement or limb repositioning ,May migrate to other areas of the body within the same seizure (most commonly contralaterally but can occur ipsilaterally as well),If generalized, the seizure activity is diffuse, bilateral, and synchronous
- Focal tonic seizures :Manifests as a continuous but transient extremity posturing or asymmetric posturing of the trunk or neck ,May include horizontal eye deviation ,If generalized, may mimic decerebrate posturing (upper and lower extremity tonic extension) or decorticate posturing (upper extremity flexion and lower extremity extension)
- Myoclonic seizures(Sharma et al;2014) :Manifests as nonrepetitive contractions ,Involves flexor muscle groups of the extremity (commonly upper extremity), trunk, diaphragm, or face ,If generalized, the seizures may appear as bilateral jerking of the flexor muscles of the upper and lower extremities.
- Subtle (unspecified) seizure is the most common type of convulsion. It includes movements such as a tremor in the eyelids; a fixed gaze in the eyes or horizontal deviation; smacking, chewing, or other oral movements; and pedaling gestures. Autonomic findings such as tachycardia andhypotension often accompany these findings.
Treatment / Management :After ensuring the patient has a patent airway, is hemodynamically stable, and has intravenous access, therapy should be targeted to treat the underlying condition identified. This can include therapeutic hypothermia for hypoxic-ischemic encephalopathy, (Papile et al ;2014) 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(Sharma\&Prasad;2017) If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.(Glass et al;2016) ,Its mechanism of action is the synaptic inhibition through an action on GABA receptors, It can not only control seizures but also reduce the metabolism of the brain .(Geneva;2011) ,Phenobarbital can control 43-80% of electrical seizures (abnormal electroencephalograms) in newborns.(Sharpe et al;2020) Levetiracetam can also be used for treatment of neonatal seizures, which is safer than phenobarbital, it's mechanism of action is modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain, with less side effects on cognitive development in the levetiracetam treated subjects.(Maitre et al;2013)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- Neonates present with Convulsions
Key inclusion criteria (1 listed)
- All neonates with convulsions.
Key exclusion criteria (1 listed)
- 1.Convulsions that occur beyond neonatal period. 2.Secondary neonatal convulsions eg: hypoglycemic, hypocalcemic, hypomagnesemic convalsions.
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
Number of attacks
Time frame: baseline
Phenobarbital versus levetracetam (Efficacy and safety ) in treatment of neonatal convulsion
Incidence of Possible side effects of both drugs include
Time frame: baseline
Possible side effects of both drugs include: * Hypotension * Bradycardia * Respiratory abnormalities * Sedation * Irritability * Poor feeding * Need of oxygen, mechanical ventilation or vasopressor medication * Apnea * Hypersensitivity reaction (angioedema, skin rash) * Bleeding (per gum, nose, urine)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 26 Dec 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attacks (time frame: baseline). The study lists 2 primary outcomes in all. 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 26 Dec 2023.