Pregnancy Exposure to TNF alpha inhibitors and Immunological effecT in infants
- Conditions
- immunodeficiency, inflammatory bowel disease
- Registration Number
- NL-OMON22495
- Lead Sponsor
- haga ziekenhuis, den Haag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
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 Parents must have sufficient understanding of the Dutch language and be able to give informed consent. Parents must own a smartphone in order to be able to use the InfectionApp.
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, golimumab or eternacept are excluded, because they are hardly present in the cohort of pregnant women with IBD. In addition, certolizumab hardly passes the placenta
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>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)<br>2) the frequency of infections
- Secondary Outcome Measures
Name Time Method