I.V. Levetiracetam versus Phenobarbitone in Neonatal Seizures A Randomized, Single Blind Prospective Clinical Trial
*Adel A H Mahmoud FRCP Department Of Pediatrics, National Neuroscience Institute King Fahad Medical City, Saudi Arabia
*Corresponding Author: Adel A H Mahmoud FRCP
Department Of Pediatrics, National Neuroscience Institute King Fahad Medical City, Saudi Arabia Email:email@example.com
Published on: 2017-12-18
Objective: Seizures in neonates are relatively common. Only few studies are available about the safety and efficacy of antiepileptic drugs used for treatment of neonatal seizures. The standard treatment has been Phenobarbitone (PB). Usually it is given as intravenous (I.V.) and followed when it is successful, by the oral form. Recently Levetiracetam (LEV) was studied with promising results. Here we compare the safety and efficacy of LEV with PB in the treatment of neonatal seizures. Methods: This is a randomized single blind study conducted at King Fahd medical city: a tertiary care hospital in Saudi Arabia between 2008 and 2015. The Institution Review Board approved the study. Parental agreement was obtained by signing informed consent prior to participation in the study. It is monophasic 22 neonates (birth to 28 days of age) with clinical seizures were recruited from the Neonatal Intensive Unit. They were randomized into 2 groups, group1 or 2, utilizing one of the readily available programs of randomization on the Internet. Group 1: treated with I.V. PB with possible switch to I.V. LEV if the former fails, while group 2 treated with I.V. LEV with possible switch to PB if the former fails. Treatment was randomly chosen and given by the Neonatal Intensive Care nurse as prescribed by physician on duty (patients do not know which drug is used). Seizure classification was adopted from Volpe.. Clinical detection was the essence of diagnosing seizures. This reflected practical choice due to the non-availability of handy electroencephalograms (EEGs).
Seizures in neonates are relatively common, with variable clinical manifestations. Most of the time they are of earliest signs of neurological dysfunction, and they may predict long-term cognitive and developmental sequalae . The effects of neonatal seizures on the immature brain are difficult to distinguish from those of the brain lesions causing them, however the presence of prolonged seizures in the neonatal period represents an important risk factor for poor prognosis or developing neurological sequelae. The mortality risk is still high (22-58%) in preterm births despite its reduction in term babies (7 to 16%) and the overall risk of impairment following neonatal seizures is still as high as 30% .