Journal article

A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study

SR Dalziel, J Furyk, M Bonisch, E Oakley, M Borland, J Neutze, S Donath, C Sharpe, S Harvey, A Davidson, S Craig, N Phillips, S George, A Rao, N Cheng, M Zhang, K Sinn, A Kochar, C Brabyn, FE Babl

BMC Pediatrics | BIOMED CENTRAL LTD | Published : 2017

Abstract

Background: Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phen..

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Grants

Awarded by National Science Foundation


Funding Acknowledgements

The study is funded by grants from the Health Research Council of New Zealand (HRC 12/525), Auckland, New Zealand; A+ Trust (Auckland District Health Board), Auckland, New Zealand; Queensland Emergency Medicine Research Foundation, Milton, Queensland, Australia (EMPJ-105R21-2014FURYK); Private Practice Research and Education Trust Fund, The Townsville Hospital and Health Service, Douglas, Queensland, Australia; Eric Ormond Baker Charitable Fund, Equity Trustees, Clayton, Victoria, Australia; and Princess Margaret Hospital Foundation, Perth, Western Australia, Australia. The PREDICT network is supported as a Centre of Research Excellence for Paediatric Emergency Medicine by the National Health and Medical Research Council, Canberra, Australian Capital Territory, Australia (NHMRC GNT1058560). The Victorian sites were supported by the Victorian Government's Infrastructure Support Program, Melbourne, Victoria, Australia. FEB's time was part funded by a grant from the Murdoch Childrens Research Institute and the Royal Children's Hospital Foundation, Melbourne, Victoria, Australia. SRD's time was part funded by the Health Research Council of New Zealand (HRC13/556). The study sponsor is Starship Children's Health, Private Bag 92,024, Auckland 1142, New Zealand. Neither the funder, nor the sponsor, have any role in study design, collection, data management, analysis, interpretation of data, proposed writing of reports or decision to submit for publication. These tasks are the responsibility of the study investigators.