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ISRCTN
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ISRCTN11862726
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ClinicalTrials.gov identifier
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Public title
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A randomised double blind placebo controlled trial of Fosphenytoin for prevention of seizures in children with acute non-traumatic encephalopathies
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Scientific title
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Acronym
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FOSCOM - FOSphenytoin in non-traumatic COMa
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Serial number at source
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SSC 819
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Study hypothesis
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Seizures in acute encephalopathies are associated with neuro-cognitive impairment following recovery. Prevention of the seizures (which may manifest as convulsions, abnormal motor posturing or electrographic seizures) during the acute illness may improve the neuro-cognitive outcome.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Acute non-traumatic encephalopathies
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Participants - inclusion criteria
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1. Children who are unable to localise a painful stimulus 30 minutes after a seizure or correction of hypoglycaemia
2. Written informed consent from the parents or guardian
3. Age nine months to 13 years
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Participants - exclusion criteria
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1. Children with a history of epilepsy, significant developmental delay, cerebral palsy, or sickle cell disease
2. Children who would have received phenytoin for treatment of seizures before recruitment
3. Evidence of head trauma
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Anticipated start date
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28/12/2004
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500 - recruitment ends on the 31st December 2007
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Interventions
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This is a double blind randomised controlled trial to evaluate the safety and efficacy of a single intramuscular (im) injection of Fosphenytoin, 20 mg Phenytoin equivalents/kg in children with acute non-traumatic encephalopathies, given at admission to prevent seizures and abnormal motor posturing during stay in hospital and neuro-cognitive deficits assessed at three and 24 months. The control intervention is a placebo of normal saline.
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Primary outcome measure(s)
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1. The proportion of patients with clinical or electrographic seizures after intervention
2. The proportion of patients with abnormal motor posturing after intervention
3. The proportion of patients with neuro-cognitive deficits three months after discharge
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Secondary outcome measure(s)
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1. Mortality in either group
2. Proportion of children who develop status epilepticus after intervention
3. Frequency and types of adverse events
4. Mean duration of seizures that occur after the intervention
5. Changes in cerebral blood flow velocity in the middle cerebral artery during seizure episodes
6. Time to regain full consciousness
7. Duration of hospitalisation
8. Neurocognitive deficits at 24 months
The sample of 500 (i.e. 250 in each arm) has a 90% power at 5% level of significance to detect the following changes after allowing for a 20% loss to follow up and death:
a. A 50% reduction (from 27 to 13.5%) in patients with at least one seizure lasting more than five minutes or more than three seizures of any duration
b. A 50% reduction (from 34 to 17%) in patients who will develop abnormal motor posturing
c. A 50% reduction in cognitive impairment from 24 to 12% as measured by Evoked Response Potentials (ERP).
An interim analysis is planned after 200 children have been recruited into the trial.
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 070114)
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Trial website
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Publications
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Contact name
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Dr
Charles
Newton
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Address
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Neurosciences Unit
Mecklenburgh Square
University College London
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City/town
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London
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Zip/Postcode
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WC1N 2AP
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Country
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United Kingdom
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Tel
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+44 (0)20 7837 7618
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Fax
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+44 (0)20 7833 9469
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Email
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cnewton@ich.ucl.ac.uk
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Sponsor
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University College London (UK)
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Address
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Institute of Child Health
30 Guilford Street
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City/town
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London
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Zip/Postcode
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WC1N1EH
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Country
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United Kingdom
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Sponsor website:
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http://www.ich.ucl.ac.uk
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Date applied
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11/01/2005
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Last edited
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22/02/2007
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Date ISRCTN assigned
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22/07/2005
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