Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The purpose of this study is to determine the correct oral dosing, safety and efficacy for oral Levetiracetam as first line treatment in term new born babies with seizures.
This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects. Levetiracetam has great potential as a treatment for neonatal seizures but is not approved for use in children less than 1 years of age by oral. This study aims to obtain essential data regarding the efficacy and safety of oral Levetiracetam in neonatal population and simultaneously to use EEG monitoring systems that facilitate seizure detection and research. Specific aims are: 1. To determine the efficacy of oral Levetiracetam in terminating neonatal seizures by EEG in the Neonatal Neurological Intensive Care Unit (NNICU). 2. To determine dose escalation data by studying the additional efficacy of a further dose in non responders. 3. To determine additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study. 4. To determine further safety data of oral Levetiracetam in neonates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure.
Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load.
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China
EEG
Efficacy of levetiracetam by assessment of the change from baseline in EEG on Day 15.
Time frame: At Day 28
Brain Parenchyma Alterations(MRI)
Efficacy of levetiracetam by assessment of the change of brain from baseline in MRI on Day 28.
Time frame: At Day 28
Neurodevelopment(Bayley Scores)
Efficacy of levetiracetam by assessment of the change from baseline to Day 28 in neurodevelopment via Bayley Scores of Infant Development Mental Development Index (BSID).
Time frame: At Day 28
Seizure Control Days
Efficacy of levetiracetam by assessment of seizure control days.
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Adverse Events（Abnormal Appearance）
This is a composition of general appearance, abdomen, skin, head and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Adverse Events（Abnormal Blood Pressure）
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Adverse Events(Pulse)
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Adverse Events(Respiratory)
Time frame: From Day 1 to Day 28 post-dose in each period
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Number of Abnormal Clinical Chemistry
Safety of levetiracetam by assessment of safety laboratory tests.
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Abnormal Hematology
Safety of levetiracetam by assessment of safety laboratory tests.
Time frame: From Day 1 to Day 28 post-dose in each period
Number of Abnormal Clinical Urinalysis
Safety of levetiracetam by assessment of safety laboratory tests.
Time frame: From Day 1 to Day 28 post-dose in each period