6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day

Escalation of dose after 6 patients treated to 40 mg/kg IV load and 10mg/kg/day maintenance
levetiracetam : 20 mg/kg loading dose; 5 mg/kg daily for 7 days.
levetiracetam : 40 mg/kg IV load; 10 mg/kg/day maintenance

Levetiracetam Dose Escalation

Sex: Female, Male

Region of Enrollment

Participants in both low dose and high dose arms are reported together

All Participants

Drug Clearance

6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily
levetiracetam: 20 mg/kg loading dose; 5 mg/kg daily for 7 days.

Levetiracetam Low Dose

12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day

Levetiracetam High Dose

Levetiracetam Treated Number of Participants With Serious Adverse Events

Drug Half Life

Levetiracetam 20 mg/kg load followed by 5 mg/kg/day for 7 days. n=6

Levetiracetam 40 mg/kg load followed by 10 mg/kg/day for 7 days. n=12

Overall Study

Sponsor and Principal Investigator

There were two arms (1) Levetiracetam 20 mg/kg load followed by 5 mg/kg/day for 7 days. n=6 and (2) Levetiracetam 40 mg/kg load followed by 10 mg/kg/day for 7 days. n=12, however the data collected regarding adverse events was not recorded according to group, so all participants are reported together.

Seizures

Disorder of Fetus or Newborn

20 mg/kg loading dose; 5 mg/kg daily for 7 days.

Low dose levetiracetam

40 mg/kg IV load; 10 mg/kg/day maintenance

esterase/seizures

Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures

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