A study to control the effectiveness of two drugs, which are phenobarbitone (used for seizures in first 28 days of life) and levetiracetam ( new drug for seizures) in newborns who have seizures in the first 24 hours of life with delayed cry at birth.

Efficacy of Levetiracetam versus Phenobarbitone in the control of neonatal seizures in asphyxiated newborns as first line therapy: a randomised controlled trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024952

Enrollment

Registered

2020-04-30

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: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Comparing efficacy of levetiracetam and phenobarbitone in control of neonatal seizures due to perinatal asphyxia: Neonates will be loaded with IV levetiracetam in a dose of 40mg/kg dilu

Eligibility

Inclusion criteria

Inclusion criteria: Full termGestational age more than equal to 37 weeks Birth weight more than or equal to2 kgs Perinatal asphyxia defined as:APGAR score less than 5 at 5 minutes, Cord pH less than 7.0, Base deficit more than12 : in deliveries attended by the pediatrician at the hospital , Delayed onset of cry after 3 min of birth in deliveries not attended by doctor or at home. HIE with clinical seizures : onset within 24 hours of life Inborn neonates admitted on day one of life

Exclusion criteria

Exclusion criteria: Anticonvulsant prior to admission Neonatal seizures due to proven metabolic causes: hypoglycemia, hypocalcaemia, etc. Neonates who are treated with therapeutic hypothermia Serum creatinine levels > 1.5mg/dl Gross congenital malformations TORCH infections

Design outcomes

Primary

Measure	Time frame
Clinical and electrical control (using aEEG) of seizure activity in the neonates within one hour of loading with the drug and no recurrence for the next 24 hours.Timepoint: 1 day	—

Secondary

Measure	Time frame
Short term toxicity of levetiracetam will be monitored:Apnea within 4 hour period following Levetiracetam infusion,Anaphylactic shock occurring following the levetiracetam infusion, toxic epidermic necrosis Steven Johnson syndrome,Serum creatinine levels 2. Any adverse effects with phenobarbitone will be monitored: Irritability, Sedation, Hypotension,Respiratory suppression,hepatotoxicity Timepoint: 1 day	—

Measure

Time frame

Short term toxicity of levetiracetam will be monitored:Apnea within 4 hour period following Levetiracetam infusion,Anaphylactic shock occurring following the levetiracetam infusion, toxic epidermic necrosis Steven Johnson syndrome,Serum creatinine levels 2. Any adverse effects with phenobarbitone will be monitored: Irritability, Sedation, Hypotension,Respiratory suppression,hepatotoxicity Timepoint: 1 day

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Countries

India

Contacts

Public ContactShradha zutshi

Pt. BD Sharma PGIMS Rohtak

gehlawatv@gmail.com9812768686

Outcome results

None listed

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