Actively Recruiting

Phase Not Applicable
Age: 1Hour - 24Months
All Genders
Healthy Volunteers
NCT07316465

Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis

Led by Universitair Ziekenhuis Brussel · Updated on 2026-01-05

500

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

Sponsors

U

Universitair Ziekenhuis Brussel

Lead Sponsor

V

Vrije Universiteit Brussel

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis

Who Can Participate

Age: 1Hour - 24Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborns planned to be born at the maternity ward of UZ Brussel
  • 400 newborns with high risk for atopic dermatitis (at least 1 parent or sibling with doctor-diagnosed atopic dermatitis, asthma, or allergic rhinitis)
  • 100 newborns with low risk for atopic dermatitis (no parents or siblings with history of atopic dermatitis, asthma, or allergic rhinitis)
Not Eligible

You will not qualify if you...

  • Newborns not born at the maternity ward of UZ Brussel
  • Parents with poor understanding of Dutch, French, or English
  • Newborns admitted post-partum to neonatal intensive care unit (gestational age less than 34 weeks) or with medical complications
  • Newborns with severe genetic abnormalities or birth defects
  • Newborns whose parents cannot attend study visits for 2 years due to location or work schedule

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)

Jette, Brussels Capital, Belgium, 1090

Actively Recruiting

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Research Team

I

Inge Kortekaas Krohn, PhD

CONTACT

C

Carine Vleminckx

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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