Designing a trial for neonatal seizure treatment

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Stevenson , N J & Vanhatalo , S 2018 , ' Designing a trial for neonatal seizure treatment ' Seminars in Fetal & Neonatal Medicine , vol. 23 , no. 3 , pp. 213-217 . https://doi.org/10.1016/j.siny.2018.02.005

Title: Designing a trial for neonatal seizure treatment
Author: Stevenson, Nathan J.; Vanhatalo, Sampsa
Contributor: University of Helsinki, Department of Neurosciences
University of Helsinki, HUH Medical Imaging Center
Date: 2018-06
Number of pages: 5
Belongs to series: Seminars in Fetal & Neonatal Medicine
ISSN: 1744-165X
URI: http://hdl.handle.net/10138/298905
Abstract: Neonatal seizures are widely considered a neurological emergency with a need for prompt treatment, yet they are known to present a highly elusive target for bedside clinicians. Recent studies have suggested that the design of a neonatal seizure treatment trial will profoundly influence the sample size, which may readily increase to hundreds or even thousands as the achieved effect size diminishes to clinical irrelevance. The self-limiting and rapidly resolving nature of neonatal seizures diminishes the measurable treatment effect every hour after seizure onset and any effect may potentially be confused with spontaneous resolution, precluding the value of many observational studies. The large individual variability in seizure occurrence over time and between etiologies challenges group comparisons, while the absence of clinical signs mandates quantification of seizure occurrence with continuous multi-channel EEG monitoring. A biologically sound approach that views neonatal seizures as a functional cot-side biomarker rather than an object to treat can overcome these challenges. (C) 2018 Elsevier Ltd. All rights reserved.
Subject: ANTICONVULSANT TREATMENT
Antiepileptic drug
BIG DATA
BURDEN
ELECTROGRAPHIC SEIZURES
EPILEPSY
Episodic illness
HYPOXIC-ISCHEMIC ENCEPHALOPATHY
Infection
MANAGEMENT
Migraine
Neonatal seizure
Randomized control trial
SINGLE-CHANNEL EEG
STATUS EPILEPTICUS
Status epilepticus
THERAPEUTIC HYPOTHERMIA
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