Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT04832269
Eligibility Criteria:
Inclusion Criteria:
* MS diagnosis was made based on the McDonald criteria valid at the time of diagnosis
* Written consent by the legal guardians of the participating child following a detailed oral and written education
* Exposed group (n=40): Children and adolescents (aged 8 to 18 years) of mothers with prenatal exposition to MP in the context of a MS relapse therapy
* Non-exposed group (n=40): Children and adolescents of mothers suffering from MS without MP therapy during pregnancy (aged 8 to 18 years) matched for age, gender and social background
Exclusion Criteria:
* Perinatal complications such as cerebral bleeding, neonatal intensive care with ventilation, prenatal therapy with glucocorticoids except for an MS relapse
* Maternal abuse of noxious agents during pregnancy
* Long-term glucocorticoid medication (e.g. asthma)
* Preterm births (before 36 weeks of pregnancy)
* Severe disease making an examination impossible (e.g. mental retardation)
* disease-modifying therapy during pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT04832269
Study Brief:
Protocol Section:
NCT04832269