Infantile Spasms (IS) Nervous System Diseases Other generalized epilepsy and epileptic syndromes
Conditions
Interventions
All infants and children will receive initial IS conventional therapy, consisting of Vigabatrin (VGB) administration (as well as vitamin B6), followed after a two week period by Adrenocorticotropic Ho
Sponsors
Hôpital Sainte-Justine (Montréal) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 3 - 18 months, either sex, with new onset infantile spasms 2. Electroencephalogram (EEG) showing hypsarrhythmia or modified hypsarrhythmia 3. Children not receiving treatment for infantile spasms at the time of the initial visit, i.e. vigabatrin or synacthen 4. Parents or legal guardian agree to sign the consent form
Exclusion criteria
Exclusion criteria: 1. Age under 3 months or over 18 months at onset of spasms 2. Degenerative neurological disorder because their relentless course toward a poor outcome regardless of therapeutic interventions would limit the possibility of generalising our findings to all children with infantile spasms 3. Pre-existing medical condition where steroids would be contraindicated 4. Families unable to comply with follow-up visits or agree to informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intelligence Quotient (IQ) scores are evaluated with Bayley scales at time 0 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Autistic behaviour 2. Longitudinal development and pattern of developmental progress in infants and children 3. Occurrence of IS | — |
Countries
Canada
Outcome results
None listed