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Comparison of effects of phenobarbital and levetiracetam in neonatal seizure control

Comparison of effects of phenobarbital and levetiracetam in the control of neonatal seizure

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200528047589N1
Enrollment
74
Registered
2020-09-08
Start date
2020-08-22
Completion date
Unknown
Last updated
2020-10-06

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

Conditions

Neonatal seizures. Convulsions of newborn

Interventions

Intervention 1: In the intervention group, patients are treated with levetiracetam injection (500 mg / 5ml STRAGEN pharmaceutical company) at a loading dose of 30 mg / kg and infusion rate of 2 mg / k

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Months

Inclusion criteria

Inclusion criteria: pregnancy age of 34 weeks or more Weight of greater than or equal to 2 kg Hospitalization due to seizure of unknown cause in the pediatric emergency room or neonatal intensive care unit

Exclusion criteria

Exclusion criteria: underlying anomaly Systemic metabolic disease Structural disorders of the brain Previous history of anticonvulsant medication Presence of drug allergies including urticaria, flushing, angioedema, anaphylaxis

Design outcomes

Primary

MeasureTime frame
Control of seizures after drug injection. Timepoint: 15 minutes after administration of the drug in cases of seizures and within 24 hours in cases where the seizures have stopped. Method of measurement: Stoping seizure movements clinically.

Secondary

MeasureTime frame
The need or lack of need to continue anticonvulsant medication at discharge. Timepoint: at the time of discharge. Method of measurement: Diagnosis of the treating physician.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholam ali Maamouri

Mashhad University of Medical Sciences

MaamouriGh@mums.ac.ir+98 51 3841 2069

Outcome results

None listed

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