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To compare the effect of two anticonvulsant drugs levetiracetam and phenobarbitone in neonates with seizures.

EFFICACY OF LEVETIRACETAM Vs PHENOBARBITONE IN NEONATAL SEIZURES: A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045658
Enrollment
216
Registered
2022-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: G89-G99- Other disorders of the nervous system

Interventions

Intervention1: Levetiracetam [LEV]: loading with LEV 20mg/kg iv in neonates with seizures :if seizures stop put on maintenance dose @ 20mg/kg/day
if seizures continue Reload with LEV 20mg/kg followed by maintenance dose of 40mg/kg/day
if seizures still persist switch over to Phenobarbitone. Control Intervention1: Phenobarbitone [Pb]: Loading with Pb 20mg/kg iv in neonates with seizures: if seizures stop put on maintenance dose @ 3m
if seizures continue reload with Pb 10mg/kg followed by maintenance dose of 5mg/kg/day
if seizures still persist switch over to levetiracetam

Sponsors

Sarojini Naidu Children Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates with clinical seizures not controlled after correction of hypoglycemia and hypocalcemia

Exclusion criteria

Exclusion criteria: Neonates already on anticonvulsant therapy neonates with unstable vitals neonates with major congenital malformations

Design outcomes

Primary

MeasureTime frame
cessation of seizures within 48 hours of administration of first or second loading dose of the drug [ levetiracetam Vs Phenobarbitone]Timepoint: 48 hours

Secondary

MeasureTime frame
Adverse immediate effects within 3 hours The percentage of neonates who failed treatment with either levetiracetam or phenobarbitoneTimepoint: 3 hours

Countries

India

Contacts

Public ContactDr Manisha Maurya MD

Motilal Nehru Medical College, Allahabad

drmanisha99@yahoo.com9335982127

Outcome results

None listed

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