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Study comparing efficacy of two drugs as first line drug in late preterm and term babies with Neonatal Seizure.

Phenobarbitone versus Levetiracetam as 1st line therapy for Neonatal Seizures- A Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049794
Enrollment
108
Registered
2023-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes

Interventions

Intervention1: Levetiracetam: Inj Levetiracetam (40mg/kg then 20mg/kg) as 1st line drug in Neonatal Seizures given over 20 minutes. Control Intervention1: Phenobarbitone: Inj Phenobarbitone (20mg/kg t

Sponsors

TATA MAIN HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All term and late pre-term neonates ( >35weeks of gestation) with clinically apparent seizures and lasting for 3 minutes.

Exclusion criteria

Exclusion criteria: Neonates- 1. Who had received any previous anticonvulsants. 2. With correctable metabolic abnormalities(like hypoglycemia/hypocalcemia) 3. With myoclonic jerks. 4. With major congenital malformation or syndromes

Design outcomes

Primary

MeasureTime frame
Termination of clinical seizures (seizure control in 60 minutes and no further seizure in 24 hours)Timepoint: Termination of clinical seizures (seizure control in 60 minutes and no further seizure in 24 hours)—

Secondary

MeasureTime frame
1. Cessation of Seizure for 48 hours 2. Survival at discharge 3. Duration of hospital stay 4. Adverse event occuring within 2 hours of drug administration.Timepoint: 48 hours—

Countries

India

Contacts

Public ContactBhupendra Kumar Gupta

TATA Main Hospital

bhupendra.gupta@tatasteel.com

Outcome results

None listed

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