A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures

PHASE2RecruitingINTERVENTIONAL
Enrollment

133

Participants

Timeline

Start Date

March 24, 2023

Primary Completion Date

July 1, 2027

Study Completion Date

December 31, 2027

Conditions
Neonatal SeizureNeonatal EncephalopathyHypoxic-Ischemic EncephalopathySeizure Newborn
Interventions
DRUG

Levetiracetam Injection

Neonates will be treated with intravenous levetiracetam 60mg/kg for first line management of seizures, and if seizures persist will be randomized to receive higher dose Levetiracetam or standard of care phenobarbital

DRUG

Phenobarbital Sodium Injection

Standard of care for neonatal seizures

Trial Locations (4)

1023

RECRUITING

Auckland City Hospital, Auckland

1050

RECRUITING

Middlemore Hospital, Auckland

55455

RECRUITING

University of Minnesota, Minneapolis

92093

RECRUITING

University of California, San Diego, San Diego

All Listed Sponsors
collaborator

University of Minnesota

OTHER

collaborator

Rady Children's Hospital, San Diego

OTHER

collaborator

Auckland City Hospital

OTHER_GOV

collaborator

University of Auckland, New Zealand

OTHER

collaborator

Middlemore Hospital, New Zealand

OTHER

lead

University of California, San Diego

OTHER