Clinical Research Directory

Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development

Sponsor: Fundació Sant Joan de Déu

Summary

What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy. These treatments are necessary for women with autoimmune, inflammatory, allergic, or cancer-related diseases who cannot stop their medication while pregnant. Why is it important? Although these treatments help keep the mother and baby healthy, some medications can cross the placenta and affect the baby's immune system. Since pregnant women are usually not included in clinical trials, the investigators still don't know exactly how these drugs might influence the baby's immune development. How will the investigators do it? The investigators will follow a group of pregnant women receiving these treatments and monitor their babies at birth, and at 3, 6, and 12 months. The study will take place in three leading hospitals in Spain: Hospital Sant Joan de Déu, Hospital Clínic, and Vall d'Hebron. The investigators will also use organoid models in the lab to better understand how these drugs affect fetal development. Who will benefit? This study will help parents concerned about the impact of treatments during pregnancy on their child's health. It will also give doctors the evidence they need to make safer treatment decisions, and support the creation of new clinical guidelines to protect both mothers and babies.

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

Key Details

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Locations (3)