Comprehending Atopic Risk Elements (CARE): An observational study to determine lifestyle, biophysical and environmental risk factors in the development of early-onset pediatric atopic dermatitis

Background Atopic dermatitis and food allergies affect a growing swath of the population and there is consensus that their development is determined by a confluence of inherent and environmental factors. Of the numerous influences identified, a significant proportion of them are readily accessible from birth, thereby potentially opening a path for risk stratification from birth. The CARE study aims to harness this knowledge, coupled with advances in machine learning predictive modeling, to effectively determine whether a neonate is at-risk for developing atopic dermatitis or food allergies from birth. Methods & Design The CARE study is a prospective observational study of neonates recruited 1-5 days following birth from the neonatal ward of participating medical centers. Upon recruitment, trans-epidermal water loss measurements will be taken from neonates and their biological parents, and a survey will be administered to parents to record various environmental, historic and lifestyle elements that may contribute to or protect against the development of atopic dermatitis and food allergy. Follow-up questionnaires will be administered at ages 6, 12 and 24 months. Atopic dermatitis outcome measures, primarily a modified version of the UK Working Party diagnostic criteria for atopic eczema, will be assessed at 6, 12 and 24 months and food allergy outcome measures will be assessed at 12 and 24 months of age. Discussion The data generated from the CARE trial will serve to validate the notion that easily-accessible measures of risk can enable risk stratification from birth for infants at-risk of developing atopic dermatitis and food allergies. Trial Registration [www.clinicaltrial.gov][1] [NCT04325451][2], prospectively registered on March 27, 2020 ### Competing Interest Statement MB, KG, AL & TL report personal fees from MYOR Diagnostics Ltd., during the conduct of the study; In addition, MB has patent US 2010/0285110 pending. ### Clinical Protocols ### Funding Statement This study is funded by MYOR Diagnostics ltd. The funding source played an active role in the design and execution of this study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Helsinki Committee of the Meir Medical Center, Kfar Sabba, Israel (approval number 241-20) and by the Helsinki Committee of the Poriya Medical Center, Tiberias, Israel (approval number 0107-19). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Not applicable * AD : Atopic Dermatitis CARE : Comprehending Atopic Risk Elements FA : Food allergy POEM : Patient Oriented Eczema Measurement TEWL : Trans-epidermal water loss [1]: http://www.clinicaltrial.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04325451&atom=%2Fmedrxiv%2Fearly%2F2023%2F11%2F01%2F2023.11.01.23297922.atom