Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFundació Sant Joan de Déu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
High-exposed group: monoclonal treatment throughout pregnancy.
Low-exposed group: monoclonal treatment limited to the first/second trimester.
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.
Disqualifiers
None
Trial population
Pregnant women with immune-mediated inflammatory or oncologic diseases. 90 mother-child pairs: 15 per each of the 6 disease groups: rheumatology, neuroimmunology, dermatology, inflammatory bowel disease, allergy, and oncology.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Monoclonal antibody
Drugnon-intervention. Drug used in clinical practice as per practitioner decision
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Pregnant women with chronic inflammatory and/or oncological diseases exposed to mAb during pregnancy1 intervention
Trial outcomes
Primary outcomes
1
Growth
Growth will be measured with OMS scale. The World Health Organization (WHO) Child Growth Standards (0-5 years) and WHO Growth Reference (5-19 years) use Z-scores to assess growth, typically ranging from -6 to +6, with most values between -3 and +3. Higher scores indicate greater body size, which can mean better growth (e.g., height-for-age) or a worse outcome (e.g., overweight or obesity in BMI-for-age), depending on the growth index used.
Time frame
first 12 months of age2
Neurodevelopment
Neurodevelopment will be measured with Haizea-Llevant scale. The Haizea-Llevant scale is a standardized tool used in Spain to assess neurodevelopment in children aged 0 to 5 years, based on the Denver Developmental Screening Test. It evaluates development across four domains, and scores are reported as age of acquisition of milestones or percentile ranges, with higher scores indicating better neurodevelopmental outcomes; there is no fixed minimum or maximum, as it depends on age-specific milestones. A child scoring below the 3rd percentile in one or more areas may indicate developmental delay and require further evaluation.
Time frame
first 12 months of age3
Infection history
Number and type of infections will be recorded
Time frame
first 12 months of age4
Vaccine response
IgG responses to tetanus, diphtheria and pneumococcus
Time frame
first 12 months of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Sant Joan de Déu
Lead sponsor
Hospital Clinic of Barcelona
Collaborator
Hospital Vall d'Hebron
Collaborator
Source ClinicalTrials.gov