Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181383
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-11-26
Brief Title:
Phenobarbital Versus Levetiracetam Neonatal Convulsion
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Phenobarbital Versus Levetiracetam Neonatal Convulsion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
If the seizure is clinically evident and prolonged the most common first-line agent utilized is phenobarbitalGlass et al2016 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 Geneva2011 Phenobarbital can control 43-80 of electrical seizures abnormal electroencephalograms in newbornsSharpe et al2020 Levetiracetam can also be used for treatment of neonatal seizures which is safer than phenobarbital its 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 subjectsmaigre et al2013
Detailed Description:
Neonatal seizures are a commonly encountered neurologic condition in neonatesGlassHC 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 periodAbendwusthoff2012
Diagnoses that require priority evaluation and urgent treatment are categorized as follows
1 Metabolic disturbances soul2018 as Hypoglycemia Hall et al2006 Hypocalcemia Nardone et al2016
2 Hypoxic conditions Glass et al2016 Hypoxic-ischemic encephalopathy Perinatal asphyxia
3 Intracranial hemorrhage IntraventricularIntraparenchymalSubarachnoid Subdural
4 Infection as Bacterial meningitis Group B Streptococcus Escherichia coli Listeria monocytogenesku at al2015
5 Inborn errors of metabolism - selected enzyme deficiencies as Urea cycle defectsYu pearl2013 vitamin and cofactor deficiencies as Pyroxidine deficiency
6 Thromboembolic as Arterial ischemic strokeGovaert et al2009 The incidence of Neonatal seizures has been reported between 1 to 55 per 1000 live births in term infants with higher incidences reported in preterm infantsOrivoli et al 2015
The classification of neonatal seizure types and their significant features are as follows
1 Focal clonic seizuresVolp1989 Manifests as repetitive rhythmic contractions It can involve the face upper or lower extremities neck or trunkIt 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 wellIf generalized the seizure activity is diffuse bilateral and synchronous
2 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
3 Myoclonic seizuresSharma et al2014 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
4 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 sepsismeningitis 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 initiatedSharmaPrasad2017 If the seizure is clinically evident and prolonged the most common first-line agent utilized is phenobarbitalGlass et al2016 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 Geneva2011 Phenobarbital can control 43-80 of electrical seizures abnormal electroencephalograms in newbornsSharpe et al2020 Levetiracetam can also be used for treatment of neonatal seizures which is safer than phenobarbital its 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 subjectsMaitre et al2013
Diagnoses that require priority evaluation and urgent treatment are categorized as follows
1 Metabolic disturbances soul2018 as Hypoglycemia Hall et al2006 Hypocalcemia Nardone et al2016
2 Hypoxic conditions Glass et al2016 Hypoxic-ischemic encephalopathy Perinatal asphyxia
3 Intracranial hemorrhage IntraventricularIntraparenchymalSubarachnoid Subdural
4 Infection as Bacterial meningitis Group B Streptococcus Escherichia coli Listeria monocytogenesku at al2015
5 Inborn errors of metabolism - selected enzyme deficiencies as Urea cycle defectsYu pearl2013 vitamin and cofactor deficiencies as Pyroxidine deficiency
6 Thromboembolic as Arterial ischemic strokeGovaert et al2009 The incidence of Neonatal seizures has been reported between 1 to 55 per 1000 live births in term infants with higher incidences reported in preterm infantsOrivoli et al 2015
The classification of neonatal seizure types and their significant features are as follows
1 Focal clonic seizuresVolp1989 Manifests as repetitive rhythmic contractions It can involve the face upper or lower extremities neck or trunkIt 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 wellIf generalized the seizure activity is diffuse bilateral and synchronous
2 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
3 Myoclonic seizuresSharma et al2014 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
4 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 sepsismeningitis 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 initiatedSharmaPrasad2017 If the seizure is clinically evident and prolonged the most common first-line agent utilized is phenobarbitalGlass et al2016 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 Geneva2011 Phenobarbital can control 43-80 of electrical seizures abnormal electroencephalograms in newbornsSharpe et al2020 Levetiracetam can also be used for treatment of neonatal seizures which is safer than phenobarbital its 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 subjectsMaitre et al2013
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None