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The effect of levetiracetam and phenobarbital on the control of neonatal seizures

Comparison of efficacy and safety of Levetiracetam and Phenobarbital in controlling neonatal seizures

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160523028008N23
Enrollment
40
Registered
2022-06-13
Start date
2022-05-05
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Convulsions of newborn. Convulsions of newborn

Interventions

Intervention 1: Intervention group: Patients are treated with levetiracetam injection (500 mg / 5ml by Estragen Company, Switzerland) at a loading dose of 50 mg/kg and infusion rate of 2 mg/kg/min (wi

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Gestational age of 36 weeks or more Weighing 2 kg or more Occurrence of neonatal seizures between the first day and the 28th day after birth Consent of the baby's parents or legal guardian

Exclusion criteria

Exclusion criteria: Receiving anti convulsion drugs in the last 72 hours Seizures due to hypocalcemia, hypoglycemia, hypomagnesemia, and other electrolyte disorders Serum creatinine level greater than 1.6 mg / dL

Design outcomes

Primary

MeasureTime frame
Complete cessation of seizures for 24 hours after medication. Timepoint: In the first 24 hours after medication. Method of measurement: Stopping seizure movements clinically (clinical assessment).;Number of doses received to stop seizures. Timepoint: In the first 24 hours after medication. Method of measurement: Patient medical record.

Secondary

MeasureTime frame
Reduce irritability. Timepoint: Before and after intervention. Method of measurement: Daily clinical examination and parental observations.;Reduce anorexia. Timepoint: Before and after intervention. Method of measurement: Daily clinical examination and parental observations.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNader Faraji

Hamedan University of Medical Sciences

naderfaraji59@gmail.com+98 912 248 3658

Outcome results

None listed

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