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A clinical trial to compare the efficacy of phenobarbitone with levetiracetam for the treatment of seizures (fits) in newborns

Comparison of phenobarbitone with levetiracetam for the treatment of seizures in term and near term neonates.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001863
Enrollment
60
Registered
2011-07-06
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: IV LEVETIRACETAM : Intervention Agent- IV Levetiracetam is given at loading dose of 60 mg/kg followed by maintenance at 30mg/kg/day 12th hrly. Control Intervention1: Intervention -Levet

Sponsors

DR AMIT UPADHYAY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.patients with clinically apparent seizures with perinatal asphyxia, and HIE With weight greater than 2 kg. 2. patient with seizures not responding to treatment of hypoglycemia, hypocalcemia.

Exclusion criteria

Exclusion criteria: 1.Serum creatinine greater than 1.2 at enrollment or greater than 2 at any time. 2.Major congenital malformations 3.Sick neonates with significant respiratory distress requiring assisted ventilation,ionotropic support,symptomatic hypocalcemia/hypoglycemia,renal/cardiac failure.

Design outcomes

Primary

MeasureTime frame
clinical control of seizuresTimepoint: 12 hrs from last episode of seizures

Secondary

MeasureTime frame
Incidence of electrical seizures after control of clinical seizuresTimepoint: At 3 months and at 6 months of age.;Neurological examinationTimepoint: At time of discharge, at 3 months and at 6 months.;Safety profile of levetiracetam.Timepoint: At 3 and 6 months of age;Time taken to control clinical seizuresTimepoint: At the time of admission

Countries

India

Contacts

Public ContactDr AMIT UPADHYAY
anuamit7@rediffmail.com9412205009

Outcome results

None listed

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