European Paediatric AFM Associated With EV-D68 Follow-up Study. (NCT03499366) | Clinical Trial Compass
UnknownNot Applicable
European Paediatric AFM Associated With EV-D68 Follow-up Study.
Norway40 participantsStarted 2018-04-09
Plain-language summary
The study is a follow-up study on children with acute flaccid paresis associated with enterovirus D68 infection. Only children living in Europe are eligible. The study aim is to clarify the outcome of the disease and investigate possible clinical correlation with outcome, including initial severity, demographic characteristics, treatment and MRI findings.
Who can participate
Age range
1 Day – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Acute flaccid paresis (AFP) at onset, and
* Enterovirus D-68 polymerase chain reaction (PCR) positive in any specimen in a timely sample (+/- 3 weeks from onset of paresis), and
* Age \<18 years at onset, and
* Magnetic resonance imaging (MRI) of spine and brain at onset with signs of myelitis.
Exclusion Criteria:
* Major trauma
* central nervous system (CNS) malignancy
* Bleeding or infarctions in CNS
* Previous demyelinating disease
* Other infections cause of myelitis is more likely
* Patient and/or legal guardian is not able/willing to sign the consent form
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Hammersmith Functional Motor scale- score at follow-up