Quality of Life in Children After Multisystem Inflammatory Syndrome in Children (NCT07126028) | Clinical Trial Compass
By InvitationNot Applicable
Quality of Life in Children After Multisystem Inflammatory Syndrome in Children
Croatia85 participantsStarted 2024-04-01
Plain-language summary
The aim of this observational study is to assess whether Multisystem Inflammatory Syndrome (MIS-C) in children affects their quality of life. The investigators will examine whether there is a correlation between paediatric mortality prediction scoring systems, specific clinical and laboratory indicators, and whether some of these can predict the level of quality of life in children 24 months after hospital discharge.
The primary questions are:
Do children who survived MIS-C have a poorer quality of life 24 months after the illness compared to their peers? Can investigators identify prognostic indicators to create preventative strategies for MIS-C?
The investigator will compare the quality of life in participants who survived MIS-C with a control group. The quality of life will be measured using a validated questionnaire.
In the first phase, data from medical records will be collected. In the second, prospective part of the study, participants, healthy peers, and their parents or guardians will be asked to complete a questionnaire about quality of life.
Who can participate
Age range
1 Month – 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:
* children of the same age and gender as the children in MIS-C group
Exclusion Criteria:
* history of acute hospitalisations in hospitals for any reason
* chronic health problems (including chronic childhood diseases and chronic physical disabilities)
Examples of chronic diseases include:
* childhood asthma
* cystic fibrosis
* congenital heart defects
* diabetes mellitus
* epilepsy
* chronic inflammatory bowel disease
* celiac disease
* rheumatological diseases such as juvenile idiopathic arthritis
* psychiatric disorders (e.g., attention deficit hyperactivity disorder and depression).
Examples of chronic physical disabilities include:
* hearing or vision impairment
* cerebral palsy
* myelomeningocele
* loss of limb function
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
To assess the quality of life of children with and treated for MIS-C 24 months after hospital discharge
Timeframe: from enrollment (24 weeks after hospital discharge) to the end of completing the questionnaire at 12 weeks
2
The quality of life of healthy peers
Timeframe: From enrollment to the end of completing the questionnaire at 12 weeks.