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Bathing Babies and Allergy (BBA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03050658
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Information provided by (Responsible Party):
Julia Wisniewski, MD, University of Virginia

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.

Condition or disease
Atopic Dermatitis Allergy

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 144 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skin Integrity After Newborns' First Bath And Development of Eczema and Allergy at 2 Years
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Eczema

Primary Outcome Measures :
  1. Change in skin transepidermal water loss (TEWL) [ Time Frame: 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 ]
    Change in TEWL, before (baseline) versus after baby's first bath, will be measured.

Secondary Outcome Measures :
  1. Skin microorganisms [ Time Frame: 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 ]
    Skin will be swabbed for microflora analysis before and after baby's first bath

  2. Number of participants with physician-diagnosis of atopic dermatitis and allergy [ Time Frame: 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 ]
    Prevalence of physician-diagnosed AD and allergy will be calculated among subjects at 2 years

Biospecimen Retention:   Samples Without DNA
skin swabs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy term newborn babies admitted to the Well Newborn Service at the University of Virginia.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03050658

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Contact: Katherine A Boguszewski 434-243-9663
Contact: Julia Wisniewski, MD 4342439663

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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Katherine Boguszewski    434-243-9663   
Principal Investigator: Julia A Wisniewski, MD         
Sponsors and Collaborators
University of Virginia
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Responsible Party: Julia Wisniewski, MD, Assistant Professor, University of Virginia Identifier: NCT03050658    
Other Study ID Numbers: 19587
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate