Levetiracetam Versus Phenobarbitone for the Treatment of Neonatal Seizures in a Tertiary Care Hos… (NCT07401433) | Clinical Trial Compass
CompletedNot Applicable
Levetiracetam Versus Phenobarbitone for the Treatment of Neonatal Seizures in a Tertiary Care Hospital.
Pakistan260 participantsStarted 2024-04-08
Plain-language 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.
Who can participate
Age range
1 Day – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Neonates (0-28 days old) with clinically diagnosed seizures.
* Both term and preterm neonates.
* Admitted to the neonatal intensive care unit (NICU) or pediatric ward.
* Written informed consent obtained from parents or legal guardians.
Exclusion Criteria:
* Neonates with major congenital anomalies or genetic syndromes.
* Neonates with severe renal or hepatic impairment.
* Neonates with metabolic disorders requiring specific treatment (e.g., hypoglycemia, hypocalcemia) unless seizures persist after correction.
* Neonates already receiving anticonvulsant therapy prior to admission.
* Neonates with confirmed meningitis or central nervous system infections requiring specific management (unless seizures persist after appropriate treatment).
* Neonates with life-threatening conditions where study treatment cannot be safely administered.
* Parents or legal guardians refusing consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seizure Cessation Within 40 Minutes
Timeframe: Immediately after first-line drug administration (within 40 minutes)