Atopic Dermatitis Clinical Trial
— BBAOfficial title:
Skin Integrity After Newborns' First Bath And Development of Eczema and Allergy at 2 Years
Atopic dermatitis (AD) is a chronic allergic skin disease with onset in early childhood and
increasing prevalence in Westernized countries. Current well newborn guidelines for washing
babies with soap were adopted by U.S. hospitals in the 1970s, before the rise in prevalence
of allergic disease and AD (also called eczema). Increased transepidermal water-loss (TEWL)
in newborn skin at 2 days of life was recently identified as a predictor of AD and allergy
development by age 2 years. Risk for AD in babies was also linked to decreased skin
colonization with certain skin microflora, such as staphylococcal organisms. Together, these
data raise the question of whether newborn skincare guidelines have the potential to modify
a baby's risk for allergy development. Our current practice of washing babies with soap may
alter TEWL or other natural factors in skin that protect babies from development of AD and
allergy. More knowledge is needed about the impact of infant skincare practices on allergy
development.
The objective of this pilot study is to determine the impact of a baby's first bath on
his/her transepidermal water loss (TEWL) and skin microflora. Study procedures will include
collection of TEWL measurements and skin swabs for skin microflora analysis pre/post first
bath in healthy term newborns at UVA. This data will serve as preliminary data for future
studies.
Status | Recruiting |
Enrollment | 144 |
Est. completion date | January 1, 2022 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility |
Inclusion Criteria: - Healthy term (>36 weeks GA) baby - Born at UVA - Admitted to the well newborn nursery - Baby's mother is at least 18 years old and capable of providing informed consent Exclusion Criteria: - Babies born to cognitively-impaired mothers (unable to provide consent). - Babies of prisoners. - Babies of non-English speaking mothers (due to limited resources available for study conduct). - Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant or would render the participants unable to comply with the protocol. |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Health System | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in skin transepidermal water loss (TEWL) | Change in TEWL, before (baseline) versus after baby's first bath, will be measured. | Within baby's first 72 hr of life, TEWL will be measured at baseline and then at 18 to 36 hours after their first bath in the hospital | |
Secondary | Skin microorganisms | Skin will be swabbed for microflora analysis before and after baby's first bath | Within baby's first 72 hr of life, skin will be swabbed for microflora at baseline and then at 18 to 36 hours after their first bath in the hospital | |
Secondary | Number of participants with physician-diagnosis of atopic dermatitis and allergy | Prevalence of physician-diagnosed AD and allergy will be calculated among subjects at 2 years | At 2 years of life, subjects will be assessed for any physician-diagnosis of atopic dermatitis (AD) or allergy during their first 24 months of life |
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