Abstracts

Rationale: New antiepileptic drugs (AEDs) are being indicated in newborns without enough clinical evidence. Purpose: To analyze the efficacy and safety of new AEDs in newborns with refractory seizures. Methods: Observational prospective study of newborns with seizures admitted between June 2005 and May 2012 at the Italian Hospital Neonatology Unit. Results: 116 consecutive newborns with seizures were included. We analyzed 17 (14.6%) with refractory seizures that receives new AEDs, 70% term and 30% premature. 70.58% had a symptomatic partial epilepsy and 29.42% presented a Neonatal Epileptic encephalopathy. Overall in-hospital mortality was 11.7%. The new AEDs indicated as second-line anticonvulsant treatment were: Vigabatrine in 2p., Oxcarbacepine 4p., Levetiracetam 1p., and Topiramate in 1p. As a 3rd or 4th AED: Vigabatrine in 7p., Levetiracetam 4p., Topiramate 3p., Oxcarbacepine 2p. and Valproate in 1 p. We observed a 50% or more seizure reduction in 10p. (58%) and 4p. (23.5%) with complete cessation of seizures. We noticed a 50% or more seizure reduction with Oxcarbacepine in 4/5p., Levetiracetam 3/5p. and Vigabatrine in 4/9p. No adverse events were reported during treatment with any anticonvulsant. Conclusions: In our study, we observed a favorable seizure control in newborns with refractory seizures with new AEDs. The development of new prospective studies are needed, including more newborns, to assess the efficacy, safety and neuroprotective effect of new AEDs as first-line treatment.