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Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and Behaviour

NCT04832269 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-03-06

No results posted yet for this study

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 sensitivity, cognitive dysfunction and neuro-psychiatric disorders in later life which all predict early brain ageing. Another common source of fetal GC exposure is the treatment of relapses in multiple sclerosis (MS), the most common neurological disease in young women. Despite the lack of studies, the 300-fold higher dosage of GCs for MS relapse treatment compared to obstetric indications is considered harmless for the fetus . Objectives: To examine the effects of GCs for MS relapse treatment during pregnancy on offspring structural and functional brain development, stress sensitivity, and cognitive and behavioural performance. Methods: Epidemiological multi-centre cohort study in 80 children and adolescents aged 8 to 18 years whose mothers received GCs to treat a MS relapse during pregnancy compared to unexposed participants. Expected Impact: Creating a guideline-changing evidence-based risk-benefit assessment regarding benefits of the MS relapse therapy for the mother and potential harm to the child.

Conditions

Interventions

OTHER

Exposure to methylprednisolone during pregnancy

Exposure to methylprednisolone during pregnancy in the context of an MS relapse therapy

Sponsors & Collaborators

  • Ruhr University of Bochum

    collaborator OTHER

  • Interdisciplinary Center of Clinical Research of the Medical Faculty Jena

    collaborator UNKNOWN

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • Florian Rakers · University Hospital Jena

  • Matthias Schwab, Prof. Dr. · University Hospital Jena

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04832269 on ClinicalTrials.gov