Levetiracetam (Keppra®) in neonates: safety of intravenous levetiracetam for neonates with seizures
| ISRCTN | ISRCTN53371491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53371491 |
| Secondary identifying numbers | NL907 (NTR930) |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 22/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr L S Smit
Scientific
Scientific
Erasmus Medical Centre
Sophia Children's Hospital
Department of Neonatology Intensive Care
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 463 6077 |
|---|---|
| l.s.smit@erasmusmc.nl |
Study information
| Study design | Non-randomised, non-controlled, clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Levetiracetam (Keppra®) in neonates: safety of intravenous levetiracetam for neonates with seizures |
| Study objectives | The use of parenterally administered Levetiracetam (LEV) (Keppra®) in neonatal epileptic seizures, detected electrographically, with or without clinical signs, will be safe, and pharmaco-kinetic and -dynamic properties of the use in neonates will be determined. |
| Ethics approval(s) | Approval received from the METC Erasmus MC Rotterdam on the 12th March 2007. |
| Health condition(s) or problem(s) studied | Neonatal seizures |
| Intervention | Keppra® intravenous (iv) 20 mg/kg, when no response another 20 mg/kg. 15 times withdrawal from blood from arterial catheter. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levetiracetam (Keppra®) |
| Primary outcome measure | 1. Safety profile of LEV in neonates 2. Safety outcome parameters as liver, kidney and metabolic function, electrolytes, haemodynamic effects (heart rate/arrhythmia, arterial blood pressure/hypotension) 3. Investigation of pharmaco-kinetic and -dynamic properties of LEV in neonates At t = 0, 12 and 24 hours physical examination will be performed. Vital signs and EEG will be monitored continuously up to 24 hours. Hepatic and kidney functions will be determined at t = 0 and t = 24 hours. LEV plasma concentrations at t = 0, 5, 15, 20, 30, 60 minutes and t = 4, 8, 12, 24, 36, 48, 60 and 72 hours. |
| Secondary outcome measures | Increase of epileptic activity and drug interaction will be determined or registered. At t = 0, 12 and 24 hours physical examination will be performed. Vital signs and EEG will be monitored continuously up to 24 hours. Hepatic and kidney functions will be determined at t = 0 and t = 24 hours. LEV plasma concentrations at t = 0, 5, 15, 20, 30, 60 minutes and t = 4, 8, 12, 24, 36, 48, 60 and 72 hours. |
| Overall study start date | 01/04/2007 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 10 |
| Key inclusion criteria | 1. All neonates with electrographical epileptic seizures, diagnosed by Electroencephalogram (EEG): a. with or without clinical signs b. multiple (greater than one in 30), defined as the evolution of sudden, repetitive evolving stereotyped forms with a definite beginning, middle and end, lasting at least eight seconds c. or status epilepticus, defined as continuous seizure activity for at least 30 minutes or recurrent seizure activity for greater than 50% of the entire recording duration 2. Newborn gestational age greater than 37 weeks, birth weight greater than 1500 grams 3. Refractory to phenobarbitone up to 40 mg/kg or refractory to phenobarbitone up to 40 mg/kg and midazolam up to 0.5 mg/kg (raised from 0.1 mg/kg every 10 to 15 minutes when effect fails) (depending on moment of referral with history of medication) 4. After correction or treatment of metabolic causes of the as inborn errors, hypoglycaemia or hypocalcaemia or Central Nervous System (CNS) infections 5. Arterial catheter |
| Key exclusion criteria | 1. Newborn gestational age less than 37 weeks 2. Birth weight less than 1500 grams |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Department of Neonatology Intensive Care
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
22/09/2021: Proactive update review. No publications found. Search options exhausted.
