Status:
RECRUITING
Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and Behaviour
Lead Sponsor:
Jena University Hospital
Collaborating Sponsors:
Ruhr University of Bochum
Interdisciplinary Center of Clinical Research of the Medical Faculty Jena
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
8-18 years
Brief Summary
Introduction: Fetal exposure to glucocorticoids (GCs) used to induce fetal lung maturation in women threatened by premature labour is known to induce aberrations in brain development and stress sensit...
Detailed Description
Introduction: Multiple Sclerosis (MS) affects 1 in 1,000 people in industrialised countries, mainly women of childbearing age. To prevent MS relapses, most patients receive disease-modifying therapies...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04832269
Start Date
October 19 2020
End Date
December 31 2024
Last Update
March 6 2024
Active Locations (2)
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1
Ruhr University of Bochum
Bochum, Germany, 44791
2
University Hospital Jena
Jena, Germany, 07747