When IgE autoantibodies appear in newborns at risk for atopic dermatitis
Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort
This study will test whether newborns with a family history of allergy already have self-reactive IgE antibodies at birth and whether those antibodies link to later atopic eczema.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 1 Hour to 24 Months |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Jette, Brussels Capital) |
| Trial ID | NCT07316465 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are newborns delivered at the UZ Brussel maternity ward whose parents can communicate in Dutch, French, or English, including 400 infants with at least one first-degree relative with diagnosed atopic dermatitis, asthma, or allergic rhinitis and 100 low-risk controls.
Not a fit: Newborns born elsewhere, those admitted to neonatal intensive care (gestational age <34 weeks) or with major birth defects, and families unable to attend follow-up visits are not eligible and are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could identify early biological markers that predict which infants are likely to develop atopic dermatitis, enabling earlier monitoring or preventive strategies.
How similar studies have performed: Prior studies have detected IgE autoantibodies in a subset of infants and people with atopic dermatitis, but large prospective birth-cohort data linking early-life autoreactivity to later AD are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jette, Brussels Capital
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.