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The effect of Levetiracetam and phenobarbital in treatment of neonatal seizures

Clinical trial of comparison of intravenous Levetiracetam and phenobarbital for first line treatment of acute neonatal seizures

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090412001808N7
Enrollment
50
Registered
2020-01-24
Start date
2018-05-22
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute neonatal seizure. Epilepsy and recurrent seizures

Interventions

Intervention 1: Intervention group: Levetiracetam made by Estragen Company, Switzerland with initial loading dose of 30 mg/kg with slow intravenous infusion is injected for 15 minutes and maintenance

Sponsors

Sari University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Term neonates Age = 28 days Clinical seizures requiring treatment based on the diagnosis of a neonatalologist Seizure diagnosis based on pediatric neurologist diagnosis and EEG interpretation Written informed consent of parents

Exclusion criteria

Exclusion criteria: Renal failure Seizures caused by electrolyte disorders such as hypocalcemia and hypoglycemia Patients whose seizures respond to vitamin B6 administration Sensitivity to Levetiracetam or phenobarbital Structure Anomaly Asphyxia

Design outcomes

Primary

MeasureTime frame
Seizure. Timepoint: 30 min, 24 hour up to 1 week, 1st month, 2nd month, 3rd month. Method of measurement: Clinical examination and observation of paroxysmal movements of the neonate.

Secondary

MeasureTime frame
Sizure recurrence. Timepoint: 30 min, 24 hour up to 1 week, 1st month, 2nd month, 3rd montt. Method of measurement: Clinical examination and observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Abbaskhanian

Sari University of Medical Sciences

snali45@yahoo.com+98 11 3334 2334

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026