A randomised double-blind placebo-controlled trial of Fosphenytoin for prevention of seizures in children with acute non-traumatic encephalopathies
| ISRCTN | ISRCTN11862726 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11862726 |
| Secondary identifying numbers | SSC 819 |
- Submission date
- 11/01/2005
- Registration date
- 22/07/2005
- Last edited
- 06/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Charles Newton
Scientific
Scientific
Neurosciences Unit
Mecklenburgh Square
University College London
London
WC1N 2AP
United Kingdom
| Phone | +44 (0)20 7837 7618 |
|---|---|
| cnewton@ich.ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | A randomised double-blind placebo-controlled trial of Fosphenytoin for prevention of seizures in children with acute non-traumatic encephalopathies |
| Study acronym | FOSCOM - FOSphenytoin in non-traumatic COMa |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute non-traumatic encephalopathies |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fosphenytoin |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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. |
| Overall study start date | 28/12/2004 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 9 Months |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 500 |
| Key inclusion criteria | 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 9 months to 13 years |
| Key exclusion criteria | 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 |
| Date of first enrolment | 28/12/2004 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- Kenya
- United Kingdom
Study participating centre
University College London
London
WC1N 2AP
United Kingdom
WC1N 2AP
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Institute of Child Health
30 Guilford Street
London
WC1N1EH
England
United Kingdom
| Website | http://www.ich.ucl.ac.uk |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
