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. 2020 Jul 12;10(7):e033801.
doi: 10.1136/bmjopen-2019-033801.

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

Trine Gerner  1   2 , Anne-Sofie Halling  1   2 , Maria Rasmussen Rinnov  1   2 , Nina Haarup Ravn  1   2 , Mette Hjorslev Knudgaard  1   2 , Charlotte Menné Bonefeld  3 , Caroline Ewertsen  4 , Simon Trautner  5 , Ivone Jakaša  6 , Sanja Kezic  7 , Lone Skov  1   2 , Jacob P Thyssen  8   2
Affiliations

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

Trine Gerner et al. BMJ Open. .

Abstract

Introduction: Skin barrier development and dysfunction in premature and mature newborns is important for the risk of atopic dermatitis (AD).

Methods and analysis: 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).

Ethics and dissemination: 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.

Keywords: Raman; TEWL; atopic dermatitis; birth cohort; preterm; skin barrier.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Scheduled investigations for preterm children in the BABY Cohort. AD, atopic dermatitis; BABY, Barrier dysfunction in Atopic newBorns studY; mo, months; TEWL, transepidermal water loss.
Figure 2
Figure 2
Scheduled investigations for term children in the BABY Cohort. AD, atopic dermatitis; BABY, Barrier dysfunction in Atopic newBorns studY; mo, months; TEWL, transepidermal water loss.
See this image and copyright information in PMC

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