immunodeficiency after intra exposure to TNF alpha inhibitors
Conditions
Interventions
None listed
Sponsors
HagaZiekenhuis
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Infants with intra uterine exposure to anti-TNFa (with or without other immunosuppressive drugs) for maternal IBD and infants with intrauterine exposed to other immunosuppressive drugs (but no anti-TNFa) for maternal IBD OR infants with intra exposure to immunomodulating drugs because of maternal COVID-19. Parents must have sufficient understanding of the Dutch language and be able to give informed consent.
Exclusion criteria
Exclusion criteria: Infants in which informed consent is not obtained. Infants with a (possible) HIV infection, infants with an immunodeficiency as part of a known genetic or inherited disease. Infants of mothers using certolizumab or eternacept are excluded, because they are hardly present in the cohort of pregnant women with IBD. In addition, certolizumab hardly passes the placenta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In order to assess the effects of anti-TNFa on the development of adaptive and innate immunity, children exposed to anti-TNFa (with or without other immunosuppressive drugs) will be compared to children exposed to immunosuppressive drugs (but no anti-TNFa) to evaluate for differences in: 1) immunological markers in relation to anti TNFa level (immunophenotyping of T and B cell subsets (in particular memory B cells at 12 months), presence of hypogammaglobulinaemia at 12 months) 2) the frequency of infections | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Differences in other immunological markers (response to routine vaccinations (Tetanus, H Influenzae type B, Pertussis, pneumococcal conjugate vaccine), immunoglobulin levels, presence of hypogammaglobulinemia at birth, 2 and 6 months, proteomics) between children exposed to anti-TNFa (with or without other immunosuppressive drugs) and children exposed to immunosuppressive drugs (but no anti-TNFa) In order to further assess the effects of anti TNFa on the development of adaptive and innate immunity, children exposed to anti TNFa (with or without other immunosuppressive drugs) will be compared to children exposed to immunosuppressive drugs (but no anti-TNFa) and to healthy children for differences in: 2) innate and adaptive immunity by measuring immunological markers in relation to anti TNFa level (immunophenotyping of T and B cell subsets, immunoglobulin levels, presence of hypogammaglobulinemia, response to routine vaccinations (Tetanus, H Influenzae type B, Pertussis, pneumococcal conjugate vaccine), proteomics) 3) the frequency of infections 4) persistent /long term effects on the immune system by detecting epigenetic changes in mononuclear cells 5) gut microbiome Explorative objectives Infants with intra uterine exposure to immunomodulating drugs because of maternal COVID-19 will be included in a separate cohort. The objectives in this cohort will be explorative and descriptive: 1) innate and adaptive immunity: measurement of immunological markers in relation to concentration of immunomodulating drug: immunophenotyping of T and B cell subsets, immunoglobulin levels, response to routine vaccinations (Tetanus, H Influenzae type B, Pertussis, (including maternal pertussis vaccination) pneumococcal conjugate vaccine), and proteomics. 2) the frequency of infections 3) persistent /long term effects on the immune system by detecting epigenetic changes in mononuclear cells 4) gut microbiome analysis | — |
Countries
Netherlands
Outcome results
None listed