New hope for newborn seizures: levetiracetam tested as First-Line treatment
NCT ID NCT02229123
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested the drug levetiracetam as the first treatment for seizures in 18 full-term newborns who had brain injury from lack of oxygen at birth. The goal was to find the right dose and check if it is safe and effective at reducing seizure activity on brain recordings. The results could lead to a better option for controlling seizures in these fragile babies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Levetiracetam (an anti-seizure drug)
- What this could lead to
- If successful, this could provide a safer, more effective first-line treatment for seizures in newborns with brain injury.
- What could go wrong
- This is a small, early-phase study with only 18 babies, so results may not apply to all newborns. The drug may cause side effects like severe breathing problems or allergic reactions.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Feb 2018
- Finished
-
Feb 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
36 to 43 weeks
- 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.
Eligibility Criteria: 1. Male or female term baby with gestational age of 36-43 weeks and postnatal age \< or= 72 hours 2. One or more of the following : * APGAR score \< 5 at 5 mins * Umbilical cord or arterial blood sample (within one hour after birth): pH \<7.0 or base deficit \> or = 16 mmol/L or lactates \> or equal to 11 mmol/L * Abnormal neurological examination before 6 hours of life 3. Suspected clinical or EEG seizures Inclusion criteria: * A seizure lasting more than 3 minutes or more than 2 seizures lasting more than 20 seconds on a 1 hour-period on standard EEG recording 4 hours before the levetiracetam loading dose * Availability of 8 electrode EEG recording * Written informed consent of both parents or the authorized guardians * Subscription to social security health insurance are required Exclusion Criteria: * Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome or major congenital malformation * Congenital (in utero) infection (TORCH) * Babies who have received phenobarbital or any other anticonvulsive medication other than a bolus of midazolam for intubation * Anuria/renal failure defined as serum creatinine \> 150 micromol/L * Seizures secondary to treatable metabolic etiology as hypoglycemia and hypocalcemia * Corrected QT interval (QTc) greater than 450 milliseconds on the electrocardiogram (ECG) prior to inclusion in the presence or absence of a condition that promotes QT prolongation (hypokalemia, maternal treatment during childbirth or treatment of the child with drugs known to prolong QT), * Participation to an interventional research study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Neonatal seizures are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Néonatologie
Rennes, 35000, France
-
Service de Néonatologie
Tours, 37 000, France
-
Service de Pédiatrie néonatale et réanimation
Rouen, 76031, France
-
Service de réanimation et service néonatale
Orléans, 45100, France
-
Service de réanimation néonatale
Angers, 49000, France
-
Service de réanimation néonatale
Lille, 59037, France
-
Service de réanimation néonatale
Reims, 51092, France
-
Service de réanimation néonatale et pédiatrique
Paris, 75012, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.