Levetiracetam Treatment of Neonatal Seizures
- Conditions
- Neonatal Seizures
- Interventions
- Registration Number
- NCT02550028
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
Neonatal seizure occurred and was proved by EEG according to abnormal discharge of brain. one or more of the following :
- Male or female term baby with gestational >37 weeks and postnatal age < or= 28 days
- Birthweight >2500g
- Written informed consent of parent or guardian
- Babies who have been close to death
- Seizure occurred by metabolic factors (hypoglycemia, hypocalcemia, electrolyte disorder)
- Babies who have received phenobarbitone or any other anticonvulsive medication before hospitalization
- Abnormal renal function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral levetiracetam Oral levetiracetam Oral levetiracetam 50 mg/kg loading dose. 10 mg/kg 8 hourly maintenance Intravenous phenobarbital Intravenous phenobarbital Intravenous phenobarbital 20 loading dose (add to 40 mg/kg if seizure discontrol). 5 mg/kg 24 hourly maintenance
- Primary Outcome Measures
Name Time Method EEG At Day 28 Efficacy of levetiracetam by assessment of the change from baseline in EEG on Day 15.
- Secondary Outcome Measures
Name Time Method Seizure Control Days From Day 1 to Day 28 post-dose in each period Efficacy of levetiracetam by assessment of seizure control days.
Number of Adverse Events(Respiratory) From Day 1 to Day 28 post-dose in each period Brain Parenchyma Alterations(MRI) At Day 28 Efficacy of levetiracetam by assessment of the change of brain from baseline in MRI on Day 28.
Neurodevelopment(Bayley Scores) At Day 28 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).
Number of Adverse Events(Pulse) From Day 1 to Day 28 post-dose in each period Number of Abnormal Clinical Urinalysis From Day 1 to Day 28 post-dose in each period Safety of levetiracetam by assessment of safety laboratory tests.
Number of Adverse Events（Abnormal Appearance） From Day 1 to Day 28 post-dose in each period 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.
Number of Adverse Events（Abnormal Blood Pressure） From Day 1 to Day 28 post-dose in each period Number of Abnormal Hematology From Day 1 to Day 28 post-dose in each period Safety of levetiracetam by assessment of safety laboratory tests.
Number of Abnormal Clinical Chemistry From Day 1 to Day 28 post-dose in each period Safety of levetiracetam by assessment of safety laboratory tests.
Trial Locations
- Locations (1)
Children Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China