Quality of Life in Children After Multisystem Inflammatory Syndrome in Children

NCT07126028 | Enrolling By Invitation

• 1 other identifier: 003-05/22-1/93
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multisystem Inflammatory Syndrome in Children (MIS-C)

Keywords

risk adjustment; quality of life; Multisystem inflammatory Syndrome in Children

Outcome Measures

Primary Outcomes (2)

• To assess the quality of life of children with and treated for MIS-C 24 months after hospital discharge

  The quality of life of all surviving children with MIS-C will be examined using a validated questionnaire for at least 24 months from discharge from the hospital. The quality of life will be assessed using a questionnaire completed based on age, by parents or guardians for children under five, and by children over five years old themselves. The questionnaire used is the "Pediatric Quality of Life Inventory™ Generic Core Scales (PedsQL™ Generic Core Scales)." It investigates and gathers responses related to physical health and activity, emotional health, social activities, and school or kindergarten activities. Each response can score between 0 and 4 points, where 0 indicates the best outcome and 4 the worst. The responses are reverse-scored and linearly transformed into a scale so that higher scores represent better quality of life (for 0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0).

  from enrollment (24 weeks after hospital discharge) to the end of completing the questionnaire at 12 weeks

• The quality of life of healthy peers

  A control group of peers (healthy participants) of the same age and sex will complete the questionnaire. The quality of life will be assessed using a questionnaire completed based on age, by parents or guardians for children under five, and by children over five years old themselves. The questionnaire used is the "Pediatric Quality of Life Inventory™ Generic Core Scales (PedsQL™ Generic Core Scales)." It investigates and gathers responses related to physical health and activity, emotional health, social activities, and school or kindergarten activities. Each response can score between 0 and 4 points, where 0 indicates the best outcome and 4 the worst. The responses are reverse-scored and linearly transformed into a scale so that higher scores represent better quality of life (for 0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0).

  From enrollment to the end of completing the questionnaire at 12 weeks.

Study Arms (2)

MIS-C group

those children who survived MIS-C and were treated in the hospital

control Group

healthy peers without any acute diseases or chronic conditions

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects will be recruited by the primary care physician, who is also the responsible physician for the control patient treated by MIS-C, through random selection from the hospital records of children of the desired age. The responsible physician will then contact the parent of the potential healthy subject and offer them the opportunity to participate in the study.

You may qualify if:

• children of the same age and gender as the children in MIS-C group

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristina Lah Tomulić: lead

Study Sites (1)

Clinical Hospital Centre Rijeka, Department of Paediatrics

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location

MeSH Terms

Conditions

pediatric multisystem inflammatory disease, COVID-19 related

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assoc. prof.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 15, 2025
• Study Start: April 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: May 2026 - December 2026

Locations

CR (1)