[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617272":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":27,"locations":35,"responsibleParty":52,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":85,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Infants born at UZ Brussel","Cord blood, blood drawl at 6, 12 and 24 months of age, electrical impedance spectroscopy, natural moisturizing factor, skin swab, stool swab, questionnaires, skin check (disease scores). These interventions will be the same for all participants.",[12],"Other: Development of atopic dermatitis with\u002Fwithout IgE autoantibodies",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":18},"Development of atopic dermatitis with\u002Fwithout IgE autoantibodies","No studies have been performed on the presence of IgE autoantibodies at birth and whether this is related to AD development, prediction of the development of atopic diseases (biomarker) or clinical relevance in the pathophysiology. Causative environmental and hereditary factors still need to be unraveled. We assume that newborns with IgE autoantibodies are prone to develop atopic dermatitis and its comorbidities (food allergy, allergic asthma\u002F rhinitis) . In case IgE autoantibodies are identified in cord blood, this may originate from the mother and passes to the child due to maternal spillover , or it is produced by the fetus (prenatally) who produces IgE autoantibodies him\u002Fherself or by the infant in early life.\n\nThis project aims to insights to the understanding of the first stages of IgE autoantibody development, its relation to AD and other allergic diseases as well as heredity and environmental factors. The endpoints study hold the potential to improve prevention and\u002For prognosis.",[9],null,[20,24],{"name":21,"affiliation":22,"role":23},"Jan Gutermuth, MD PhD","Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)","STUDY_DIRECTOR",{"name":25,"affiliation":22,"role":26},"Inge Kortekaas Krohn, PhD","PRINCIPAL_INVESTIGATOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":18,"email":31},"CONTACT","+32 (0)2 477 4244","inge.kortekaas@vub.be",{"name":33,"role":29,"phone":18,"phoneExt":18,"email":34},"Carine Vleminckx","carine.vleminckx@uzbrussel.be",[36],{"facility":22,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Jette","Brussels Capital","1090","Belgium","BE",{"type":44,"coordinates":45},"Point",[46,47],4.33419,50.87309,{"lat":47,"lon":46},[50,51],{"name":25,"role":29,"phone":30,"phoneExt":18,"email":31},{"name":33,"role":29,"phone":18,"phoneExt":18,"email":34},{"type":26,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Inge Kortekaas","Assistant professor",[56],{"name":57,"class":6},"Vrije Universiteit Brussel","100617272","birth-cohort-development-of-ige-autoantibodies-in-newborns-with-high-risk-of-atopic-dermatitis-100617272",false,"NCT07316465","Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis","Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort","DIANA","Inclusion Criteria:\n\nNewborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:\n\n* 400 newborns with high-risk for AD-development (at least 1 parent or sibling with physician diagnosed atopic dermatitis AND\u002FOR asthma AND\u002FOR allergic rhinitis)\n* 100 newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND\u002FOR asthma AND\u002FOR allergic rhinitis)\n\nExclusion Criteria:\n\n* Newborns not born at the maternity ward of UZ Brussel\n* Parents with a poor understanding of Dutch, French or English\n* Newborns who are admitted post-partum to the neonatal intensive care unit (gestational age \\\u003C34 weeks) or with medical complications\n* Newborns with severe genetic abnormalities\u002Fbirth defects\n* Newborns whose parents will not be able to attend the study visits for a period of 2 years (location, working hours)",true,"ALL","1 Hour","24 Months",{"count":71,"type":72},500,"ESTIMATED","INTERVENTIONAL",[75],"NA","Previous research has shown that some patients with atopic eczema have specific self-reactive antibodies, known as IgE autoantibodies, that react to their own skin cells, referred to as \"self-reactive antibodies\" or \"autoantibodies\". It is not yet known when and how these self-reactive antibodies develop, so this is what we aim to investigate.\n\nThis study aims to examine the presence of self-reactive antibodies at birth. In other words, the investigators want to study the earliest stage of developing antibodies that target the body's own skin cells. Additionally, factors that contribute to the development of these self-reactive antibodies will be explored as well as the correlation with the development of atopic eczema.\n\nThe study will involve newborns who are at an increased risk of developing atopic eczema due to a family history of asthma, hay fever, or atopic eczema. There will also be a control group of newborns without these characteristics. The study's approach is to examine a portion of the umbilical cord blood, which is routinely collected after birth, to investigate self-reactive antibodies. The goal is to determine whether these self-reactive antibodies are linked to the development of atopic eczema in the first two years of life. For this purpose, follow-ups will be conducted at the ages of 6, 12, and 24 months.\n\nThis study will contribute to an increased understanding of the prevalence of self-reactive antibodies and the factors influencing their development. Moreover, the study will determine whether these antibodies play a role in the prevention of and\u002For serve as predictive factors for the development of atopic eczema.",[78,79,80,81,82,83,84],"Atopic Dermatitis (AD)","Autoantibody","Auto-Immunity","Microbiome, Human","Allergic Disease","IgE-Mediated Hypersensitivity","Newborn Infant",[86,87,88,89,64],"Birth cohort","Autoantibodies","IgE","Atopic dermatitis","2025-12-18",{"date":92,"type":93},"2026-01-05","ACTUAL",{"date":95,"type":93},"2023-10-01",{"date":97,"type":72},"2030-12-31",{"name":5,"class":6},1]