Abstracts

SAFETY AND EFFICACY OF OXCARBAZEPINE IN NEONATES IN THE NEONATAL INTENSIVE CARE UNIT

Abstract number : 2.229
Submission category : 7. Antiepileptic Drugs
Year : 2012
Submission ID : 15505
Source : www.aesnet.org
Presentation date : 11/30/2012 12:00:00 AM
Published date : Sep 6, 2012, 12:16 PM

Authors :
K. James, K. Velayudam

Rationale: Seizures are commonly seen in the neonatal intensive care unit, but there is clear lack of evidence regarding anticonvulsant use in the neonatal population. Phenobarbital and phenytoin have long been the standard of care, despite studies suggesting that they are less effective or even harmful in this age group. The objective of our study was to review efficacy and safety of oxcarbazepine in neonates in our Neonatal Intensive Care Unit (NICU). Methods: We identified 22 neonates who received Oxcarbazepine in our NICU from 2006-2011. A retrospective chart review was performed, and data was collected including gestational age at birth; corrected gestational age at seizure onset; semiology; etiology; EEG, imaging and genetic test results; prior anticonvulsants used; initial and target Oxcarbazepine dose; efficacy and adverse effects. Continuation of Oxcarbazepine upon discharge from the NICU was also evaluated as a surrogate marker of tolerability. Results: Twenty of twenty-two neonates were term. The majority (90%) developed seizures between 37-43 weeks corrected gestational age. The most common semiology was clonic (10/22), followed by tonic (5/22), eye movements or gaze deviation (5/22), apnea with desaturation (3/22), lip smacking or tongue thrusting (3/22), or bicycling movements (2/22). A minority of seizures were confirmed electrographically but were not associated with clinical signs (3/22). Ictal EEG was captured in 17/22 neonates. Almost 94% (16/17) had focal electrographic seizures. The most common etiologies included hypoxic ischemic encephalopathy, infarct, or hemorrhage (32%), or genetic abnormalities (32%). All neonates had previously failed Phenobarbital, phenytoin, Keppra, or a combination of the three. The most common starting dose of Oxcarbazepine was 10-20 mg/kg/day, although four neonates were started on 30 mg/kg/day. Sixty percent were titrated to a goal dose of 40-60 mg/kg/day. Complete seizure control was seen in 13/22 (60%) of neonates. Partial seizure control with clinically significant decrease in seizure frequency or duration was seen in 6/22 (27%). Three of 22 neonates had no change or worsening of their seizures (14%). The majority of the neonates (10/13) who had complete seizure control had focal semiology or localized ictal EEG onset. Of the three neonates who did not respond to Oxcarbazepine, one had bilateral grade IV IVH, one had bilateral hemorrhagic PCA strokes and the third had a lethal genetic mutation. Somnolence was the most common reported adverse effect, occurring in 32% of neonates. However, all were able to continue treatment. No life-threatening adverse effects were reported. All neonates continued Oxcarbazepine treatment upon discharge from the NICU. Conclusions: Our data suggests that Oxcarbazepine is a safe and effective adjunctive anticonvulsant medication in neonates with focal seizure semiology or clearly localized ictal EEG patterns. The most common adverse effect was somnolence, which tended to be mild and did not require discontinuation of therapy.
Antiepileptic Drugs