Effects of MS relapse therapy on children's brain development
Effects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain Development
This study looks at how a specific treatment for multiple sclerosis during pregnancy affects the brain development and behavior of children aged 8 to 18 whose mothers received the treatment compared to those who didn't.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 2 sites (Bochum and 1 other locations) |
| Trial ID | NCT04832269 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of glucocorticoid treatment for multiple sclerosis relapses during pregnancy on the neurocognitive development and behavior of offspring. It involves a multi-center cohort of 80 children and adolescents aged 8 to 18 years, comparing those exposed to methylprednisolone during pregnancy with those whose mothers did not receive this treatment. The study aims to assess structural and functional brain development, stress sensitivity, and cognitive performance in these children. By examining these factors, the research seeks to clarify the potential long-term effects of maternal glucocorticoid exposure on child development.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 8 to 18 whose mothers received glucocorticoid treatment for MS relapses during pregnancy.
Not a fit: Patients who experienced perinatal complications or maternal substance abuse during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety of glucocorticoid use during pregnancy and its effects on child development.
How similar studies have performed: While there is limited research specifically on this topic, studies on glucocorticoid effects during pregnancy have shown mixed results, indicating the need for further investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bochum and 1 other locations
- Ruhr University of Bochum — Bochum, Germany (Recruiting)
- University Hospital Jena — Jena, Germany (Recruiting)
Study contacts
- Principal investigator: Florian Rakers — University Hospital Jena
- Study coordinator: Michelle Dreiling, Dr.
- Email: michelle.dreiling@med.uni-jena.de
- Phone: +493641 9 32 35 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.