Status:
COMPLETED
Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study
Lead Sponsor:
University Hospital, Tours
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Rennes University Hospital
Conditions:
Neonatal Seizures
Eligibility:
All Genders
36-43 years
Phase:
PHASE2
Brief Summary
LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this study is to determine...
Detailed Description
Article Focus * The principal aim of LEVNEONAT-1 is to determine the levetiracetam optimal dose defined as the highest efficient dose under toxicity restrictions for treating neonatal seizures. * LEV...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Male or female term baby with gestational age of 36-43 weeks and postnatal age \< or= 72 hours
- 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
- 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
Exclusion
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02229123
Start Date
February 27 2018
End Date
February 23 2022
Last Update
December 30 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Service de réanimation néonatale
Angers, France, 49000
2
Service de réanimation néonatale
Lille, France, 59037
3
Service de réanimation et service néonatale
Orléans, France, 45100
4
Service de réanimation néonatale et pédiatrique
Paris, France, 75012