Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-02 @ 9:24 PM
Study NCT ID:
NCT03050658
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2017-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bathing Babies and Allergy
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Skin Integrity After Newborns' First Bath And Development of Eczema and Allergy at 2 Years
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBA
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: