Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 3:44 PM
Study NCT ID:
NCT07401433
Status:
COMPLETED
Last Update Posted:
2026-02-10
First Post:
2026-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levetiracetam Versus Phenobarbitone for the Treatment of Neonatal Seizures in a Tertiary Care Hospital.
Sponsor:
Hayat Abad Medical Complex, Peshawar
Organization:
Study Overview
Official Title:
Efficacy Of Levetiracetam in the Treatment of Neonatal Seizures Presenting at Tertiary Care Hospital.
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEV-NEO
Brief Summary:
Neonatal seizures are a common neurological emergency in newborn babies and can lead to serious brain injury if not treated promptly. Phenobarbitone is commonly used as first-line treatment, but it is associated with delayed seizure control and adverse effects such as sedation and poor feeding.
This study was conducted to compare the effectiveness and safety of levetiracetam with conventional antiepileptic drugs (phenobarbitone with or without phenytoin) in the treatment of neonatal seizures.
In this randomized controlled trial, newborns aged 0 to 28 days diagnosed with seizures were randomly assigned to receive either intravenous levetiracetam or phenobarbitone-based therapy. The main outcomes assessed were seizure control within 40 minutes, seizure freedom at 24 and 48 hours, recurrence of seizures, time taken to control seizures, adverse effects, and mortality.
The results of this study aim to provide evidence on whether levetiracetam is a safer and more effective alternative for managing neonatal seizures in a tertiary care hospital setting.
This study was conducted to compare the effectiveness and safety of levetiracetam with conventional antiepileptic drugs (phenobarbitone with or without phenytoin) in the treatment of neonatal seizures.
In this randomized controlled trial, newborns aged 0 to 28 days diagnosed with seizures were randomly assigned to receive either intravenous levetiracetam or phenobarbitone-based therapy. The main outcomes assessed were seizure control within 40 minutes, seizure freedom at 24 and 48 hours, recurrence of seizures, time taken to control seizures, adverse effects, and mortality.
The results of this study aim to provide evidence on whether levetiracetam is a safer and more effective alternative for managing neonatal seizures in a tertiary care hospital setting.
Detailed Description:
This study is a prospective, double-blinded, randomized controlled parallel-group trial conducted in the Neonatal Intensive Care Unit of the Department of Pediatrics, MTI District Head Quarter Hospital, Dera Ismail Khan. The study was carried out over a period of one year after approval from the Institutional Research and Ethics Board.
A total of 260 neonates aged 0 to 28 days with clinically diagnosed neonatal seizures were enrolled after obtaining written informed consent from parents or legal guardians. Neonates who were already receiving antiepileptic drugs or had congenital cardiac or renal diseases were excluded. Participants were randomly allocated into two equal groups using a table of random numbers with allocation concealment through sequentially numbered sealed opaque envelopes.
Group A received intravenous levetiracetam administered at a rate of 1 mg/kg/min, followed by a loading dose of 20 mg/kg diluted in normal saline. Maintenance therapy of 20 mg/kg/day was continued after seizure control. Group B received phenobarbitone as first-line therapy with a loading dose of 20 mg/kg followed by maintenance dosing. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. No crossover between groups occurred.
The primary outcome was seizure cessation within 40 minutes of drug administration. Secondary outcomes included seizure freedom at 24 and 48 hours, recurrence of seizures, mean time to seizure control, adverse effects such as sedation, respiratory suppression, hypotension, and mortality. All patients were monitored in the neonatal intensive care unit for five days and followed for up to 14 weeks after discharge.
Data were analyzed using SPSS software. Outcomes were compared between groups to evaluate the efficacy and safety of levetiracetam compared with phenobarbitone-based therapy in the management of neonatal seizures.
A total of 260 neonates aged 0 to 28 days with clinically diagnosed neonatal seizures were enrolled after obtaining written informed consent from parents or legal guardians. Neonates who were already receiving antiepileptic drugs or had congenital cardiac or renal diseases were excluded. Participants were randomly allocated into two equal groups using a table of random numbers with allocation concealment through sequentially numbered sealed opaque envelopes.
Group A received intravenous levetiracetam administered at a rate of 1 mg/kg/min, followed by a loading dose of 20 mg/kg diluted in normal saline. Maintenance therapy of 20 mg/kg/day was continued after seizure control. Group B received phenobarbitone as first-line therapy with a loading dose of 20 mg/kg followed by maintenance dosing. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. No crossover between groups occurred.
The primary outcome was seizure cessation within 40 minutes of drug administration. Secondary outcomes included seizure freedom at 24 and 48 hours, recurrence of seizures, mean time to seizure control, adverse effects such as sedation, respiratory suppression, hypotension, and mortality. All patients were monitored in the neonatal intensive care unit for five days and followed for up to 14 weeks after discharge.
Data were analyzed using SPSS software. Outcomes were compared between groups to evaluate the efficacy and safety of levetiracetam compared with phenobarbitone-based therapy in the management of neonatal seizures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: