BridgeMD
Prediction and prevention of infantile spasms in high risk children
EU CTIS ID: 2024-517488-22-00
What this study is testing
This study aims to prevent infantile spasm syndrome in high risk children (tuberous sclerosis or large vascular injury) under 1-yr old by vigabatrin prophylactic medication.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All children aged <1yr old with tuberous sclerosis (but not anymore after 11/2023), or large vascular cortical injury (large infarc-tion/hemorrhage/infection/trauma, HIE II-III including MRI criteria 2b and 3 involving cortical lesion or early stage MRI, imaged within first 5 days, general swelling of the cerebrum hemispheres and simultaneous extensive cortical/subcortical restricted diffusion finding in the ADC map). Large cortical injury is defined as almost the whole area of a. cerebri anterior or posterior, or about half of the area of a. cerebri media. Additionally, a grade IV intraventricular hemorrhage (including hemorrhagic infarction in the parenchyma) or grade III-IV PVL (containing porencephalic cyst) in premature infants. Brain MRI must have been done earlier as a part of normal clinical diagnostics.Parents must have sufficient Finnish, Swedish or English (or the native language of the research center country) language skills.
You likely can't join if
- Patient has not allowed to have received VGB for any reason before. A patient will not be recruited if he/she is already participating in another medication intervention study, or the cause of the cortical injury is child abuse. Or child has had infantile spasms before.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.