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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03050658
Other study ID # 19587
Secondary ID
Status Recruiting
Phase N/A
First received February 6, 2017
Last updated February 10, 2017
Start date February 7, 2017
Est. completion date January 1, 2022

Study information

Verified date February 2017
Source University of Virginia
Contact Katherine A Boguszewski
Phone 434-243-9663
Email KEB5UN@hscmail.mcc.virginia.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The UVA study team will perform all study-related procedures and will collect all data. Contact information and permission for the study team to contact the subject's family will be obtained at enrollment.

Pre-bath Procedures: Prior to the first bath, a study team member will:

1. Record health information about the subject.

2. Record the amount of vernix covering the subject's skin.

3. Measure skin TEWL (see TEWL below).

4. Procure skin swabs for microflora analysis (see Skin swabs below)

Post-bath Procedures: Following the subject's first bath, a study team member will repeat pre-bath procedures.

TEWL Procedure TEWL measurement will be performed using the Tewameter - a non-invasive, wand-like instrument that sits atop skin like a stethoscope and measures the water evaporating from the skin. TEWL is a validated non-invasive procedure for assessment of newborn skin integrity.

Skin Swabs Skin swabs, softer than Q-tips, will be wiped across the skin with soft pressure to allow transfer of the baby's skin microflora onto the swab for analysis of skin-colonizing microorganisms, according to established methods.

AD and allergy development by 2 years The medical charts of enrolled subjects will be reviewed at 24 months of life to determine the incidence of any physician-diagnosis of AD or allergic disease. Subjects who have no physician-diagnosis of AD or allergy in their medical record will be contacted according to the contact information they provided at enrollment. Investigators will get a medical release signed with informed consent so the study team can contact the PCP of the subject if they are not followed at UVA.

None of these procedures are part of routine care in newborns. All procedures are being done solely for research purposes and pose minimal risk to subjects.


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
United States University of Virginia Health System Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

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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