[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595531":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":22,"locations":28,"responsibleParty":65,"collaborators":67,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":10,"maxAge":10,"enrollmentInfo":81,"targetDuration":84,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Fundació Sant Joan de Déu","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant women with chronic inflammatory and\u002For oncological diseases exposed to mAb during pregnancy",null,"Study Population:\n\nInclusion criteria: Pregnant women with immune-mediated inflammatory or oncologic diseases, categorized into:\n\n1. High-exposed group: IMD treatment throughout pregnancy.\n2. Low-exposed group: IMD treatment limited to the first\u002Fsecond trimester.\n3. Non-exposed group: No IMD exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease.\n\nNewborns and an age- and sex-matched healthy control group (0-12 months) will be included.\n\nExclusion criteria for mother and child: lack of signed informed consent, primary immunodeficiencies, active infection at the time of sampling or significant comorbidities.",[13],"Drug: Monoclonal antibody",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Monoclonal antibody","non-intervention. Drug used in clinical practice as per practitioner decision",[9],[21],"non-intervention. Drug used in clinical practice",[23],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Laia Alsina, MD, PhD","CONTACT","+34 936009733","frecerca.aro@sjd.es",[29,46,57],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Hospital Sant Joan de Déu","RECRUITING","Esplugues de Llobregat","Barcelona","08950","Spain","ES",{"type":38,"coordinates":39},"Point",[40,41],2.08809,41.37732,{"lat":41,"lon":40},[44],{"name":45,"role":25,"phone":26,"phoneExt":10,"email":27},"Laia Alsina Manrique Principal Investigator",{"facility":47,"status":31,"city":33,"state":10,"zip":48,"country":35,"countryCode":36,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Hospital Clínic de Barcelona","08035",{"type":38,"coordinates":50},[51,52],2.15899,41.38879,{"lat":52,"lon":51},[55],{"name":56,"role":25,"phone":26,"phoneExt":10,"email":27},"Nuria Baños",{"facility":58,"status":31,"city":33,"state":10,"zip":48,"country":35,"countryCode":36,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Hospital Universitari Vall d'Hebrón",{"type":38,"coordinates":60},[51,52],{"lat":52,"lon":51},[63],{"name":64,"role":25,"phone":26,"phoneExt":10,"email":27},"Paula Tagliani",{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[68,70],{"name":69,"class":6},"Hospital Clinic of Barcelona",{"name":71,"class":6},"Hospital Vall d'Hebron","100595531","impact-of-in-utero-exposure-to-immunomodulatory-drugs-on-neonatal-immune-system-development-100595531",false,"NCT07033663","Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System 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","NEWbornIMMPACT","Inclusion Criteria:\n\nPregnant women with immune-mediated inflammatory or oncologic diseases, categorized into:\n\n1. High-exposed group: monoclonal treatment throughout pregnancy.\n2. Low-exposed group: monoclonal treatment limited to the first\u002Fsecond trimester.\n3. 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.\n\n   \\-","ALL",{"count":82,"type":83},90,"ESTIMATED","12 Months","OBSERVATIONAL","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.\n\nWhy 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.\n\nHow 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.\n\nWho 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.",[88,89],"Pregnancy Related","Immune-mediated Diseases",[91,92,93],"monoclonal antibodies","pregnancy","immunomodulators","2025-08-11",{"date":96,"type":97},"2025-08-15","ACTUAL",{"date":99,"type":97},"2018-06-01",{"date":101,"type":83},"2028-05-01",{"name":5,"class":6},3]