Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis
Recruiting · NCT07316465 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitair Ziekenhuis Brussel
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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)
Exclusion criteria
- Newborns not born at the maternity ward of UZ Brussel
- Parents with a poor understanding of Dutch, French or English
- Newborns who are admitted post-partum to the neonatal intensive care unit (gestational age \<34 weeks) or with medical complications
- 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)
Where it is running
1 location listed.
- Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB) - Jette, Brussels Capital, Belgium