NCT07316465Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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. This 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. The 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. This 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/or serve as predictive factors for the development of atopic eczema.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- 1 Oct 2023
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07316465
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Oct 2023 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Newborns who are admitted post-partum to the neonatal intensive care unit (gestational age \<34 weeks) or with medical complications
Other
- Newborns not born at the maternity ward of UZ Brussel
- Parents with a poor understanding of Dutch, French or English
- Newborns with severe genetic abnormalities/birth defects
- Newborns whose parents will not be able to attend the study visits for a period of 2 years (location, working hours)
Who the study is looking for
- Newborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:
- 400 newborns with high-risk for AD-development (at least 1 parent or sibling with physician diagnosed atopic dermatitis AND/OR asthma AND/OR allergic rhinitis)
- 100 newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND/OR asthma AND/OR allergic rhinitis)
Age in the registry: 1 hour to 24 months · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB) Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.