Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 2
Healthy Volunteers: t
View:

⁃ 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)

Locations
Other Locations
Belgium
Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)
RECRUITING
Jette
Contact Information
Primary
Inge Kortekaas Krohn, PhD
inge.kortekaas@vub.be
+32 (0)2 477 4244
Backup
Carine Vleminckx
carine.vleminckx@uzbrussel.be
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 500
Treatments
Other: 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.
Sponsors
Leads: Universitair Ziekenhuis Brussel
Collaborators: Vrije Universiteit Brussel, Jette, Belgium

This content was sourced from clinicaltrials.gov