Comparison of intravenous levetiracetam and phenobarbital in neonatal seizures

Comparison of intravenous levetiracetam and phenobarbital for management of neonatal seizures

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190526043717N1

Enrollment

100

Registered

2019-05-31

Start date

2019-06-10

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

Neonatal Seizures. Epilepsy and recurrent seizures

Interventions

Intervention 1: Intervention group: Levetiracetam intravenous 20-40 mg/kg/day, 15mg/kg/day per 12 h. Intervention 2: Control group: Phenobarbital 20mg/kg two time a day, increasing dose up to 30mg/kg

Eligibility

Sex/Gender

All

Age

1 Days to 12 Months

Inclusion criteria

Inclusion criteria: require for neonatal seizures management Weight > 2500gr birth age>37 weaks Individuals without renal dysfunction Individuals without dysfunction of the immune system

Exclusion criteria

Exclusion criteria: Healthy individuals Weight <2500 gr Birth age <37 weaks renal dysfunction immune system dysfunction

Design outcomes

Primary

Measure	Time frame
Seizures. Timepoint: 30 min, 24 h up to 1 w, 1th m, 2th m, 3th m. Method of measurement: clinical observation.	—

Secondary

Measure	Time frame
Neonatal seizures recurrence. Timepoint: 24 h up to 1 weak, first month, two month, and three month after intervention. Method of measurement: clinical observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Sadati

Ghoum University of Medical Sciences

a-saadatimd@yahoo.com+98 25 3665 1801

Outcome results

None listed

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