A randomised double blind placebo controlled trial of Fosphenytoin for prevention of seizures in children with acute non-traumatic encephalopathies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11862726

Enrollment

500

Registered

2005-07-22

Start date

2004-12-28

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute non-traumatic encephalopathies Signs and Symptoms Seizure

Interventions

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 n

Eligibility

Sex/Gender

All

Inclusion criteria

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 nine months to 13 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Kenya

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026