'Barrier dysfunction in Atopic newBorns studY' (BABY): protocol of a Danish prospective birth cohort study.

Skin barrier development and dysfunction in premature and mature newborns is important for the risk of atopic dermatitis (AD). The Barrier dysfunction in Atopic newBorns studY (BABY) Cohort is a prospective birth cohort study of 150 preterm children (gestational age (GA) below 37+0) and 300 term children (GA 37+0 to 41+6). Skin barrier is assessed through transepidermal water loss, tape stripping, Raman-spectroscopy and microbiome sampling. Clinical examinations are done and DNA from buccal swabs is collected for genetic analyses. Thymus size is assessed by ultrasound examination. Information on pregnancy, delivery, parental exposures and diseases are collected, and structured telephone interviews are conducted at 18 and 24 months to assess exogenous exposures in the child and onset of AD. Hanifin and Rajka criteria as well as The UK Working Party's Diagnostic Criteria for Atopic Dermatitis are used to diagnose AD. Severity of AD is assessed using the Eczema Area and Severity Index (EASI) and Patient Oriented Eczema Measure (POEM). The study is approved by the scientific Ethical Committee of the Capital Region (H-16042289 and H-16042294).Outcomes will be presented at national and international conferences and in peer-reviewed publications.

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Competing interests: JPT reports grants from The Leo Foundation, The Novo Nordisk Foundation, Pfizer, The Lundbeck Foundation and grants from Savværksejer Jeppe Juhl og hustru Ovita Juhls Mindelegat, during the conduct of the study. JPT has been an advisor, investigator and speaker for AbbVie, Regeneron, Pfizer, Sanofi Genzyme, LEO Pharma and Eli Lilly and Company.LS reports personal fees from AbbVie, Eli Lilly, Novartis, Sanofi, Celgene, LEO Pharma and Almirall, outside the submitted work. LS reports non-financial support from AbbVie, Sanofi, Janssen and grants from Novartis, Janssen and Sanofi.TG, A-SH-H, MRR, NHR and MHK report grants from Herlev and Gentofte Hospital Research Foundation during the conduct of the study.