Development of IgE autoantibodies in newborns with atopic dermatitis (DIANA): protocol of a prospective, non-interventional, observational birth cohort.

introductionAtopic dermatitis (AD) is a chronic, pruritic inflammatory skin disorder that typically begins in early childhood and affects up to 20% of children. Infants with a family history of allergic diseases or with elevated total IgE levels are at increased risk of developing AD. Emerging evidence shows that a subgroup of AD patients produce IgE autoantibodies against skin self-peptides, which are suggested to play a role in disease pathophysiology and predict the development of allergic diseases later in life. Notably, such autoantibodies have been detected in up to 15% of infants with AD under 1 year of age, indicating that IgE autoantibodies can arise early in life. The 'Development of IgE Autoantibodies in Newborns with (high risk to develop) Atopic dermatitis' (DIANA) study is a prospective birth cohort designed to address these knowledge gaps by following a target of 500 newborns during their first 24 months of life. METHODS AND DISSEMINATION: It aims to investigate the presence of IgE autoantibodies at birth (cord blood) and during early life (6, 12 and 24 months) using an immunoassay and their association with the development of AD in children from high-risk (n=400) and low-risk (n=100) families. Genetic and environmental influences are evaluated through questionnaires. Additional assessments will include skin and gut microbiome profiling using 16S rRNA sequencing (swabs), non-invasive evaluation of skin barrier function using electrical impedance spectrometry and analysis of the natural moisturising factor. We aim to decipher the underlying cause of IgE autoantibody development and allow preventive measures to counteract this. ETHICS AND DISSEMINATION: This prospective, non-interventional observational study has been approved by the Ethics Committee of Universitair Ziekenhuis Brussel/VUB (07/06/2023; EC-2023-074) and will follow Good Clinical Practice, applicable regulations and the Declaration of Helsinki. Written informed consent will be obtained from parents or legal guardians. Participation is voluntary, and consent can be withdrawn at any time. All procedures comply with GDPR to ensure data confidentiality. Participant data will be pseudonymised, with the coding key accessible only to designated study members and securely stored on a restricted-access VUB server. Findings will be disseminated through peer-reviewed publications and conference presentations. Pseudonymised data will be made available upon reasonable request in accordance with institutional policies and data protection regulations TRIAL REGISTRATION NUMBER: NCT07316465.