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To see if Levetiracetam, a new seizure control medication is better over older medication Phenobarbitone for immediate neonatal seizure control.

Levetiracetam vs Phenobarbitone in acute neonatal seizures - a Randomised Control Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/06/005849
Enrollment
32
Registered
2015-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- neonatal seizures

Interventions

Intervention1: Levetiracetam: In acute management of neonatal seizures to give 30 mg/kg/dose loading followed by 10 mg/kg/dose if seizure recurs and drug to be maintained at 20 mg/kg/day in BD dose C

Sponsors

Dr Nikhil D Kulkarni
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) > 1000 g birth weight and > 28 weeks gestation. 2)all term neonates

Exclusion criteria

Exclusion criteria: 1)hypoglycemic seizures 2)neonates treated with anticonvulsants prior to admission

Design outcomes

Primary

MeasureTime frame
Recurrence of seizure and need for another anticonvulsant.Timepoint: Immediately on the day of seizure i.e. within 24 hours.

Secondary

MeasureTime frame
Monitoring of adverse drug reactions of each drug like Phenobarbitone toxicity, mortality and neurodevelopmental follow up in follow up clinic.Timepoint: After treatment of seizures within 7 days and on followup at 1 month, 3 months,6 months, 9 months, 12 months, 15 months, 18 months and 24 months.

Countries

India

Contacts

Public ContactDr Nikhil D Kulkarni

St Johns Medical College and Hospital, Bangalore - 34

raosumanv@gmail.com9916785482

Outcome results

None listed

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