Bathing Babies and Allergy

NCT03050658 | Completed

• 1 other identifier: 19587
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis; Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Skin microorganisms

  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

• Number of participants with physician-diagnosis of atopic dermatitis and allergy

  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

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy term newborn babies admitted to the Well Newborn Service at the University of Virginia.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

skin swabs

MeSH Terms

Conditions

Dermatitis, Atopic; Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 13, 2017
• Study Start: February 7, 2017
• Primary Completion: August 30, 2019
• Study Completion: May 31, 2021
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)