Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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 the correct dosing, safety and efficacy for intravenous levetiracetam as first line treatment in term newborn babies with seizures in hypoxic-ischemic encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures in newborns.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Collaborators: Amiens University Hospital; Assistance Publique - Hôpitaux de Paris; European Georges Pompidou Hospital; Rennes University Hospital
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

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