How a mother's immunomodulatory drugs during pregnancy affect a newborn's immune development
Study of the Impact of Intrauterine Exposure to Immunomodulatory Drugs on the Development of the Immune System of Children Born to Mothers With Chronic Inflammatory or Oncologic Diseases: The NEWborn-IMM-PACT Study
This project tests whether babies born to mothers who took immunomodulatory drugs during pregnancy have measurable changes in their immune system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | Fundació Sant Joan de Déu Academic / other |
| Locations | 3 sites (Esplugues de Llobregat, Barcelona and 2 other locations) |
| Trial ID | NCT07033663 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational cohort that follows infants born to women with chronic inflammatory or oncologic diseases who received biologic immunomodulatory drugs during pregnancy. Mothers and infants are grouped by exposure level (high, low, and non‑exposed controls) and babies are seen at birth and at 3, 6, and 12 months for clinical exams and blood sampling. Laboratory analyses include serum drug levels, extended T and B cell maturation and function testing, assessment of the integrity of the drug target pathway, and epigenetic fingerprinting, and investigators will develop an in vitro organoid platform to model fetal immune effects. The study is being carried out at three major hospitals in Barcelona and aims to produce evidence to inform recommendations for medication use in pregnancy.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with autoimmune, inflammatory, allergic, or oncologic diseases who either continued monoclonal antibody or other biologic immunomodulatory therapy during pregnancy, including those with high or low exposure levels and control subjects without placental‑crossing biologics.
Not a fit: Patients unlikely to benefit include pregnant women not exposed to immunomodulatory drugs, those treated with agents that do not cross the placenta, or those unable to attend the scheduled follow-up visits.
Why it matters
Potential benefit: If successful, the findings could help doctors choose safer medications during pregnancy and guide newborn monitoring and vaccination decisions.
How similar studies have performed: Previous studies have shown some biologics can cross the placenta and influence neonatal immunity, but comprehensive prospective cohorts combining cellular, epigenetic, and organoid analyses are limited, making this approach partially novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pregnant women with immune-mediated inflammatory or oncologic diseases, categorized into: 1. High-exposed group: monoclonal treatment throughout pregnancy. 2. Low-exposed group: monoclonal treatment limited to the first/second trimester. 3. Non-exposed group: No monoclonal exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease. \-
Where this trial is running
Esplugues de Llobregat, Barcelona and 2 other locations
- Hospital Sant Joan de Déu — Esplugues de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital Universitari Vall d'Hebrón — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Laia Alsina, MD, PhD
- Email: frecerca.aro@sjd.es
- Phone: +34 936009733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.