New hope for newborn seizures: levetiracetam tested as safer alternative
NCT ID NCT07401433
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed trial tested whether levetiracetam works better and safer than the standard drug phenobarbitone for stopping seizures in newborns. 260 babies with seizures received either levetiracetam or phenobarbitone. Researchers measured how quickly seizures stopped and if they returned. The goal is to find a treatment that controls seizures faster with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- levetiracetam
- What this could lead to
- If successful, levetiracetam could become a safer, more effective first-line treatment for neonatal seizures, reducing brain injury risk.
- What could go wrong
- This is a single-center completed trial; results may not apply broadly. Levetiracetam may not outperform phenobarbitone in all settings, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
260 people
The number who actually took part.
- Started
-
Apr 2024
- Finished
-
Apr 2025
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 day to 28 days
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Gomal Medical College
Dera Ismāīl Khān, KPK, 29111, Pakistan
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