Atopic DermatitisBBANCT03050658
Bathing Babies and Allergy
An observational study of Atopic Dermatitis and Allergy, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Allergy
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy term newborn babies admitted to the Well Newborn Service at the University of Virginia.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22903
About this study
Official 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.
Read the 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:
- Record health information about the subject.
- Record the amount of vernix covering the subject's skin.
- Measure skin TEWL (see TEWL below).
- 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.
- Conditions
- Atopic Dermatitis, Allergy
- Medical subject headings
- Dermatitis, Atopic, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin transepidermal water loss (TEWL)
Change in TEWL, before (baseline) versus after baby's first bath, will be measured.
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
Skin will be swabbed for microflora analysis before and after baby's first bath
Measured: 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
Prevalence of physician-diagnosed AD and allergy will be calculated among subjects at 2 years
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start7 Feb 2017
- Primary completion30 Aug 2019
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Kellams, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050658
- Sponsor's protocol ID
- 19587
- Acronym
- BBA
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2017
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Integrity After Newborns' First Bath And Development of Eczema and Allergy at 2 Years
- ClinicalTrials.gov ID
- NCT03050658
- Acronym / sponsor ID
- BBA / 19587
- Conditions
- Atopic Dermatitis, Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Record health information about the subject.
- Record the amount of vernix covering the subject's skin.
- Measure skin TEWL (see TEWL below).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy term newborn babies admitted to the Well Newborn Service at the University of Virginia.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Allergy, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.