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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Growth
Timeframe: first 12 months of age
Neurodevelopment
Timeframe: first 12 months of age
Infection history
Timeframe: first 12 months of age
Vaccine response
Timeframe: first 12 months of age
Hypersensitivity
Timeframe: first 12 months of age
Immune Profiling in neonatal samples: Spectral flow cytometry
Timeframe: first 12 months of age
Immune Profiling in neonatal samples: T cell function
Timeframe: first 12 months of age
Immune Profiling in neonatal samples: B cell function
Timeframe: first 12 months of age
Immune Profiling in neonatal samples: Cytokine profiling
Timeframe: first 12 months of age
Immune Profiling in neonatal samples: IMD Monitoring
Timeframe: first 12 months of age
Immune Profiling in neonatal samples: Vaccine responses
Timeframe: first 12 months of age