An observational study in Neonatal Convulsion, sponsored by Assiut University. Status unknown. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by Assiut University · Observational
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)
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:
The classification of neonatal seizure types and their significant features are as follows:
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)
Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Neonates present with Convulsions
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Number of attacks
Phenobarbital versus levetracetam (Efficacy and safety ) in treatment of neonatal convulsion
Time frame: 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)
Time frame: baseline
No study locations are listed for this record.
Start is estimated for Dec 2023; primary completion for Nov 2024, 11 months later.
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This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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