Levetiracetam (Keppra®) in neonates: safety of intravenous levetiracetam for neonates with seizures

ISRCTN	ISRCTN53371491
DOI	https://doi.org/10.1186/ISRCTN53371491
Protocol serial number	NL907 (NTR930)
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Erasmus Medical Centre (The Netherlands)

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

Erasmus Medical Centre
Sophia Children's Hospital
Department of Neonatology Intensive Care
Rotterdam
3015 GJ
Netherlands

Phone	+31 (0)10 463 6077
Email	l.s.smit@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Non-randomised, non-controlled, clinical trial
Secondary study design	Non randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Levetiracetam (Keppra®)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

22/09/2021: Proactive update review. No publications found. Search options exhausted.