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

BackgroundAtopic 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 & DesignThe 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. DiscussionThe 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 Registrationwww.clinicaltrial.gov NCT04325451, prospectively registered on March 27, 2020