The effects of intra uterine exposure to Tumor Necrosis Factor alpha inhibitors in infants on the development of the immune system

Recruiting

• Conditions: immunodeficiency after intra exposure to TNF alpha inhibitors; immune disorder after use of anti-inflammatory drugs during pregnancy; 10027665; 10028920

• Registration Number: NL-OMON54516
• Lead Sponsor: HagaZiekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 210

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In order to assess the effects of anti-TNFa on the development of adaptive and<br /><br>innate immunity, children exposed to anti-TNFa (with or without other<br /><br>immunosuppressive drugs) will be compared to children exposed to<br /><br>immunosuppressive drugs (but no anti-TNFa) to evaluate for differences in:<br /><br>1) immunological markers in relation to anti TNFa level (immunophenotyping of T<br /><br>and B cell subsets (in particular memory B cells at 12 months), presence of<br /><br>hypogammaglobulinaemia at 12 months)<br /><br>2) the frequency of infections</p><br>