Status unknownMS (type not specified)NCT04832269

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Exposure to methylprednisolone during pregnancy

What it measured

Main measures

  • General cognitive ability - Reynolds Intellectual Assessment Scales and Screening (RIAS)

    approx. 30 - 40 min.

    Thinking and memory

Other measures (12)

  • Structural brain development - BrainAge score

    approx. 20 min.

    MRI lesionsBlood or spinal fluid markers
  • Salivary cortisol decay curve

    approx. 5 min. per swab

  • Salivary alpha-amylase

    approx. 5 min. per swab

  • Heart rate variability

    approx. 75 min.

  • Spectral edge frequency in the EEG

    approx. 75 min.

    Nerve conduction tests
  • External assessment sheet for attention deficit / hyperactivity disorder (FBB-ADHS, German Version)

    approx. 15 - 20 min.

    Thinking and memory
  • Child Behavior Checklist (CBCL/6-18R)

    approx. 15 - 20 min.

    Thinking and memoryMood and sleep
  • Strengths and Difficulties Questionnaire (SDQ-Deu-S)

    approx. 15 - 20 min.

    Thinking and memoryPhysical function
  • Continuous Performance Test (CPT)

    approx. 15 min.

    Thinking and memory
  • Emotional excitability scale from Personality questionnaire for children between 9 and 14 years (PFK 9-14, German Version)

    approx. 15 min.

Who could take part

MS (type not specified) · 8 to 18

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Oct 2020

    2. Main results due

      Dec 2023

    3. Finished

      Dec 2024

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