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Clinical Trials/NCT06181383
NCT06181383Not yet recruitingNot Applicable

Phenobarbital Versus Levetiracetam Neonatal Convulsion

Assiut University0 sites42 target enrollmentStarted: December 30, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
42
Primary Endpoint
Number of attacks

Study Overview

Brief 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) ,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:

  1. Metabolic disturbances (soul;2018) as Hypoglycemia, (Hall et al;2006) ,Hypocalcemia , (Nardone et al.;2016)
  2. Hypoxic conditions,( Glass et al;2016) :Hypoxic-ischemic encephalopathy ,Perinatal asphyxia
  3. Intracranial hemorrhage :(Intraventricular,Intraparenchymal,Subarachnoid ,Subdural)
  4. Infection :as Bacterial meningitis (Group B Streptococcus, Escherichia coli, Listeria monocytogenes)(ku at al;2015)
  5. Inborn errors of metabolism - selected enzyme deficiencies :as Urea cycle defects(Yu &pearl;2013), vitamin and cofactor deficiencies: as Pyroxidine deficiency.
  6. 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:

  1. 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
  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 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.
  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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Day to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All neonates with convulsions.

Exclusion Criteria

  • 1.Convulsions that occur beyond neonatal period. 2.Secondary neonatal convulsions eg: hypoglycemic, hypocalcemic, hypomagnesemic convalsions.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nashwa Nasser Heshmat

Principal Investigator

Assiut University

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