How a mother's immunomodulatory drugs during pregnancy affect a newborn's immune development
Official title: 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
Run by Fundació Sant Joan de Déu · NCT07033663 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Fundació Sant Joan de Déu Academic / other |
| Locations | 3 sites (Esplugues de Llobregat, Barcelona and 2 other locations) |
| Status | Recruiting |
| Started | June 1, 2018 |
| Main results expected | December 1, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT07033663 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Prenatal education to reduce environmental exposures during pregnancy
Aimed at pregnant people, this program tests whether a classroom-style education can help reduce exposure to harmful pollutants from seafood and nearby pollution sources.
-
Interprofessional Training to Improve Care for Peri-Delivery Patients with Substance Use Disorder
This program tests INSPIRE, a set of online and in-person trainings for healthcare teams to reduce stigma and improve care for people with substance use disorder around labor, delivery, and postpartum at the University of Utah.
-
Lower-extremity blood pressure monitoring during cesarean under spinal anesthesia
This study tests whether noninvasive blood pressure monitoring from the toe is better than the arm at predicting neonatal outcomes during cesarean delivery with spinal anesthesia.
-
Care4mommies: a compassion-based approach to support moms-to-be
A compassion-based program with pregnancy-specific content is being tested to see if it helps pregnant people build self-compassion and strengthen the bond with their baby.
-
Eating more eggs during pregnancy to support fetal brain development
This test will see if pregnant women who eat 10–14 eggs per week have better fetal brain development than those who follow a general healthy prenatal diet.
-
See if extra prenatal breastfeeding education helps moms in Inland Empire breastfeed exclusively
This study tests whether supplemental breastfeeding education during pregnancy increases exclusive breastfeeding at 6 weeks after birth for first-time moms or those who didn’t breastfeed long in the past.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.