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

Information source: University Hospital, Tours
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Seizures

Intervention: Intravenous Levetiracetam (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: University Hospital, Tours

Official(s) and/or principal investigator(s):
ELIE SALIBA, Pr, Study Chair, Affiliation: University Hospital of Tours
Geraldine FAVRAIS, Dr, Principal Investigator, Affiliation: University hospital of Tours

Overall contact:
Elie Saliba, Pr, Phone: 0247478093, Email: elie.saliba@univ-tours.fr

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 new born babies with seizures. This new anticonvulsivant drug is a promising treatment for seizures in newborns.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Optimal dose finding

Eligibility

Minimum age: 37 Weeks. Maximum age: 43 Weeks. Gender(s): Both.

Criteria:

Inclusion Criteria:

- male or female term baby with gestational of 37-43 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 > 16 mmol/L

- Postnatal resuscitation still required 10 minutes after birth

- Clinically evolving encephalopathy

- EEG: equal to or more than 3 min cumulative seizures, or 2 or more seizures of>30 sec

duration over 2 hours period within 72 hours of life

- Written informed consent of parent or guardian

- EEG monitoring has commenced within the first 72 hours of birth

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 phenobarbitone or any other anticonvulsive medication than a

bolus of midazolam for intubation within the last 24 hours

- Anuria/renal failure defined as serum creatinine > 150 micromol/L

Locations and Contacts

Elie Saliba, Pr, Phone: 0247478093, Email: elie.saliba@univ-tours.fr

Service de réanimation néonatale, Lille 59037, France; Not yet recruiting
Laurent Storme, Pr, Email: laurent.storme@chru-lille.fr
Elie Saliba, Pr, Phone: 0247478093, Email: elie.saliba@univ-tours.fr
Laurent Storme, Pr, Principal Investigator

Service de réanimation néonatale, Nantes 44093, France; Not yet recruiting
Jean-christophe Roze, Pr, Email: jeanchristophe.roze@chu-nantes.fr
Saliba, Phone: 0247478093, Email: elie.saliba@univ-tours.fr
Jean-christophe Roze, Pr, Principal Investigator

Service de néonatologie et réanimation néonatale, Poitiers 86000, France; Not yet recruiting
Khaled Husseini, Email: khaled.husseini@chu-poitiers.fr
Elie Saliba, Pr, Phone: 0247478093, Email: elie.saliba@univ-tours.fr
Khaled Husseini, Dr, Principal Investigator

Néonatologie, Rennes 35000, France; Not yet recruiting
Patrick Pladys, Pr, Email: patrick.pladys@chu-rennes.fr
ELIE SALIBA, Pr, Phone: 0247478093, Email: elie.saliba@univ-tours.fr
Patrick Pladys, Pr, Principal Investigator

Service de Pédiatrie néonatale et réanimation, Rouen 76031, France; Not yet recruiting
Alexandra Chadie, Dr, Email: alexandra.chadie@chu-rouen.fr
Elie Saliba, Phone: 0247478093, Email: elie.saliba@univ-tours.fr
Alexandra Chadie, Dr, Principal Investigator

Service de Réanimation pédiatrique, Néonatologie, Tours 37 000, France; Not yet recruiting
Elie Saliba, Pr, Email: elie.saliba@univ-tours.fr
Alexandra Kipper, Phone: 0247474665, Email: alexandra.kipper@univ-tours.fr
Elie Saliba, Pr, Principal Investigator

Additional Information

Starting date: December 2014
Last updated: September 18, 2014

Page last updated: August 23, 2015

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