ClinicalTrials.gg
Status unknownNCT06181383Updated Dec 26, 2023

Phenobarbital Versus Levetiracetam Neonatal Convulsion

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

The sponsor has not verified this record recently (last verified Dec 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
42
Ages
1 Day to 28 Days
Sex
All
01

Study 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)

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:

  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.

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)

02

Conditions studied

  • Neonatal Convulsion
03

In context

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • All neonates with convulsions.

Exclusion criteria

Exclusion Criteria:

  • 1.Convulsions that occur beyond neonatal period. 2.Secondary neonatal convulsions eg: hypoglycemic, hypocalcemic, hypomagnesemic convalsions.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
42 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of attacks

    Phenobarbital versus levetracetam (Efficacy and safety ) in treatment of neonatal convulsion

    Time frame: baseline

  2. 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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2023; primary completion for Nov 2024, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2023
First posted
Dec 26, 2023
StartEst.
Dec 30, 2023
Primary completionEst.
Nov 30, 2024
CompletionEst.
May 30, 2025
Last update
Dec 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06181383
Lead sponsor
Assiut University
Responsible party
Nashwa Nasser Heshmat (Principal Investigator, Assiut University) — Principal investigator
First posted
Dec 26, 2023
Start date
Dec 30, 2023 (estimated)
Primary completion
Nov 30, 2024 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Dec 26, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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