When IgE autoantibodies appear in newborns at risk for atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DIANA birth cohort follows 500 infants (400 at high risk, 100 low risk) born at UZ Brussel with planned follow-up to age two years. Investigators will collect cord and infant blood samples, a one-time blood sample from both parents, non-invasive skin barrier measurements, and detailed environmental and lifestyle questionnaires to look for IgE autoantibodies and inflammatory markers. Presence and timing of self-reactive IgE will be compared between high-risk and low-risk groups and related to clinical signs of atopic dermatitis over the first two years. The study examines hereditary, environmental, and skin barrier factors that may influence the earliest development of IgE autoreactivity.

Why it matters

Who can join: the full rules

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's running

• Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)
  Jette, Brussels Capital, Belgium Recruiting

Study contacts

• Principal investigator: Inge Kortekaas Krohn, PhD — Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)
• Study coordinator: Inge Kortekaas Krohn, PhD
• Email: inge.kortekaas@vub.be
• Phone: +32 (0)2 477 4244

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.