Prediction and prevention of infantile spasms in high risk children

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517488-22-00

Enrollment

140

Registered

2024-09-13

Start date

2018-05-28

Completion date

Unknown

Last updated

2026-01-02

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

Conditions

HIE II-III including MRI-criteria 2b and 3, Patients in high risk for infantile spasm syndrome (age under 1 yr old): -tuborous sclerosis (not after 11/2023) -large vascular cortical injury (large infarction/hemorrhage/infection/trauma, with also cortical lesions -grade IV intraventricular hemorrhage (including hemorrhagic infarct in brain parenchyma) -grade III-IV PVL (including porencephalic cyst) in preterms

Brief summary

Efficacy: whether patient gets infantile spasm syndrome or not

Detailed description

Is there a difference between groups in neurocognitive development? Can eye tracking analysis predict EEG changes, neurocognitive development or onset of infantile spasm syndrome?

Interventions

DRUGSabrilex 500 mg rakeet oraaliliuosta varten

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Efficacy: whether patient gets infantile spasm syndrome or not	—

Secondary

Measure	Time frame
Is there a difference between groups in neurocognitive development? Can eye tracking analysis predict EEG changes, neurocognitive development or onset of infantile spasm syndrome?	—

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026