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To compare the safety, efficacy and outcome of using Phenobarbitone and Levetiracetam in neonatal convulsions

Levetiracetam Vs Phenobarbitone In Neonatal Seizures- A Randomised Control Trial At A Tertiary Care Hospital In Southern Rajasthan - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072048
Enrollment
120
Registered
2024-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: G09- Sequelae of inflammatory diseasesof central nervous system

Interventions

Intervention1: levetiracetam: 1st loading dose 30mg/kg IV over 20 mins , 2nd loading dose 30mg/kg IV over 20 mins Control Intervention1: phenobarbitone: 1st loading dose 20mg/kg IV Slowly over 20 mins

Sponsors

RNT MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)EEG confirmed seizure in all Term and Pre-term babies admitted in NICU 2)Those patients whose guardian has given informed consent.

Exclusion criteria

Exclusion criteria: 1) Neonates with electrolyte imbalance ( Hyponatremia and Hypernatremia) 2)Hypoglycemia 3)Hypocalcemia 4) Hypomagnesemia 5)Any previous history of receiving ASM • Family history of any seizure disorder

Design outcomes

Primary

MeasureTime frame
The number of patients achieving seizure control after first and second loading dose of the drug i.e., Phenobarbitone or Levetiracetam and remaining seizure free for next 24 hours will be considered as primary outcomeTimepoint: 24hr

Secondary

MeasureTime frame
Number of patients having adverse effects occurring within 2 hours of drug administration will be considered as secondary outcome.Timepoint: 2hr

Countries

India

Contacts

Public ContactDr Bhupesh Jain

RNT MEDICAL COLLEGE

Drbhupeshudr@gmail.com9784247234

Outcome results

None listed

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