Pregnancy RelatedNCT04445298
Skin Barrier Assessment in Pregnancy and at Birth
An observational study of Pregnancy Related and Allergy, run by National Jewish Health at 1 site in United States.
Trial summary
This is a prospective birth cohort study assessing the role of maternal and environmental factors on the development of allergic diseases in children. Pregnant mothers will be enrolled and we will examine her skin barrier with skin tape strips (STS) and transepidermal water loss (TEWL), along with blood work. Read more about this study
- Who is it for?
- Ages 0 minutes to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Allergy, Atopic Dermatitis Eczema
- What is being tested?
- Transepidermal water loss, Skin tape stripping and Blood draw
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 1 Jul 2022
- 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 minutes to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: We will enroll up to 40 pregnant mothers who are expected to deliver in the fall and winter, along with up to 40 pregnant mothers who are expected to deliver in the spring and summer. The infants will then be enrolled and followed in the study.
Who may be able to join
- Pregnant women at any stage of a singleton pregnancy.
- Infant is the offspring of a woman enrolled in the study.
Who cannot join
- Use of systemic immunosuppressive drugs including oral steroids within 30 days of skin barrier assessment
- Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30 days of skin barrier assessment
- Use of topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment
- Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days, or antihistamines within 5 days of skin barrier assessment
- Has taken a bleach bath within 7 days of skin barrier assessment
- Use of emollients on the extremity being evaluated within 24 hours of skin barrier assessment
Show all 15Show fewer
- Has taken a bath or shower on the day of the skin barrier assessment
- Pregnant women with high risk pregnancies.
- Pregnancy is from an egg donation.
- Pregnant women pregnant with more than one fetus.
- Pregnant women with psychiatric and developmental co-morbidities that would render them unable to provide informed consent or perform study-related procedures.
- AIDS and HIV infection.
- A fetus with chromosomal or congenital abnormalities, a heritable hematological disorder like thalassemia or sickle cell disease in the mother.
- Infant is delivered earlier than 34 weeks gestation.
- Infant is born with a significant birth defect or medical condition where enrollment in this study is not in the infant's best interest.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Jessica Hui, MD, huij@njhealth.org
About this study
This is a prospective birth cohort study assessing the role of maternal and environmental factors on the development of allergic diseases in children. Pregnant mothers will be enrolled and we will examine her skin barrier with skin tape strips (STS) and transepidermal water loss (TEWL), along with blood work. We will then follow her offspring and perform similar testing, along with detailed questionnaires inquiring about exposures such as use of detergents and soaps, sunlight exposure, and pollution exposure. When the infant is around 12 months old, we will contact the family via telephone to see if the child developed any allergic conditions within their first year of life, such as eczema, food allergy, or wheezing. A final questionnaire will be performed.
- Being tested
- Transepidermal water loss, Skin tape stripping, Blood draw, Bacterial PCR swab
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transepidermal water lossDiagnostic test
Also called TEWL
We will assess the skin with transepidermal water loss (TEWL) by using a condenser-chamber system placed lightly on the skin. This will be performed at baseline, then after every 4 skin tape strips.
Skin tape strippingDiagnostic test
Also called STS
Adhesive skin sampling discs will be pressed against the skin in a hairless location followed by lifting it free of the skin. The discs will be evaluated for lipid content, protein, and filaggrin byproducts in the collected skin sample.
Blood drawDiagnostic test
We will draw blood to look at the vitamin D, total immunoglobulin E (IgE), and the filaggrin gene which is important in maintaining the skin barrier.
Bacterial PCR swabDiagnostic test
Also called PCR
Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with expected delivery in the fall or winter | We will enroll up to 40 women who are expected to deliver in the fall (September, October, November) and winter (December, January, February). We will then follow their infant offspring. Receives: Diagnostic Test: Transepidermal water loss; Diagnostic Test: Skin tape stripping; Diagnostic Test: Blood draw; Diagnostic Test: Bacterial PCR swab | |
| Pregnant women with expected delivery in the spring or summer | We will enroll up to 40 women who are expected to deliver in the spring (March, April, May) and summer (June, July, August). We will then follow their infant offspring. Receives: Diagnostic Test: Transepidermal water loss; Diagnostic Test: Skin tape stripping; Diagnostic Test: Blood draw; Diagnostic Test: Bacterial PCR swab | |
| Infants born in the fall or winter | The infants born to the enrolled mothers will be followed. These are infants born in the fall (September, October, November) or winter (December, January, February). Receives: Diagnostic Test: Transepidermal water loss; Diagnostic Test: Skin tape stripping; Diagnostic Test: Blood draw; Diagnostic Test: Bacterial PCR swab | |
| Infants born in the spring or summer | The infants born to the enrolled mothers will be followed. These are infants born in the spring (March, April, May) or summer (June, July, August). Receives: Diagnostic Test: Transepidermal water loss; Diagnostic Test: Skin tape stripping; Diagnostic Test: Blood draw; Diagnostic Test: Bacterial PCR swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin barrier assessment with transepidermal water loss (TEWL) will be done in every infant.
TEWL will be performed in all infants to compare skin barrier assessments between infants born in the fall and winter with those born in the spring and summer. We hypothesize greater skin barrier dysfunction in those born in the fall and winter.
Measured: 1 year
Skin barrier assessment with skin tape stripping (STS) will be done in every infant.
STS will be performed in all infants to compare skin barrier assessments between infants born in the fall and winter with those born in the spring and summer. We hypothesize greater skin barrier dysfunction in those born in the fall and winter.
Measured: 1 year
Skin barrier assessment with skin swabs for staphylococcus aureus colonization will be done in every infant.
Skin swabs for staphylococcus aureus colonization will be performed in all infants to compare skin barrier assessments between infants born in the fall and winter with those born in the spring and summer. We hypothesize greater staphylococcus aureus colonization in those born in the fall and winter.
Measured: 1 year
Skin barrier assessment with TEWL will be performed in every pregnant female and compared to her infant offspring, as well as between other pregnant females giving birth in other seasons.
We will compare the mother's skin barrier with the infant skin barrier to see if there is an association with the mother's skin barrier during pregnancy. We will perform TEWL to assess the degree of water loss before, during, and after skin tape stripping.
Measured: 1 year
Skin barrier assessment with STS will be performed in every pregnant female and compared to her infant offspring, as well as between other pregnant females giving birth in other seasons.
We will compare the mother's skin barrier with the infant skin barrier to see if there is an association with the mother's skin barrier during pregnancy. We will perform STS to determine the skin breakdown products.
Measured: 1 year
Skin barrier assessment with skin swabs for staphylococcus aureus colonization will be performed in every pregnant female and compared to her infant offspring, as well as between other pregnant females giving birth in other seasons.
We will compare the mother's skin barrier with the infant skin barrier to see if there is an association with the mother's skin barrier during pregnancy. We will perform skin swabs for staphylococcus aureus colonization to determine the presence of colonization.
Measured: 1 year
Skin barrier assessment with filaggrin gene mutation status will be determined in everyone enrolled, and we will look for the filaggrin gene mutation in both the mother and infant.
The filaggrin gene is important for skin health, and we will assess for common filaggrin gene mutations in everyone enrolled in this study via a blood draw in the mother's and cord blood in the infants.
Measured: 1 year
Vitamin D levels will be obtained and compared between individuals enrolled in this study.
Vitamin D levels will be obtained by blood draw in the pregnant mother's and cord blood in the infants. We will compare the values according to season of birth, as we hypothesize that the infants born in the fall and winter, along with their mothers, will have a lower vitamin D level.
Measured: 1 year
Questionnaires regarding exposures will be compared with the skin barrier measurements to understand exposures that lead to increased skin barrier dysfunction.
Questionnaires will be administered to capture exposures during pregnancy, such as detergents, soaps, medications, and sunlight exposure. The answers will be compared with the results of the skin barrier assessment in both pregnant women and their infants to understand which exposures lead to skin barrier dysfunction.
Measured: 1 year
Questionnaires and a follow up telephone call will allow us to see if infants born in the fall and winter have a higher incidence of allergy development.
Questionnaires and follow up telephone calls when the infant is 12 months old will determine which infants develop allergic conditions, such as atopic dermatitis, food allergy, and wheezing. We will compare the infants born in the fall and winter with those born in the spring and summer to see whether the infants born in the fall and winter have increased risk of developing allergy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start3 Aug 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald Leung, MD PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445298
- Sponsor's protocol ID
- HS3513
- Status last verified
- Sep 2020
- First submitted
- 29 Apr 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Barrier Assessment in Pregnancy and at Birth
- ClinicalTrials.gov ID
- NCT04445298
- Acronym / sponsor ID
- HS3513
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 24 Jun 2020 (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.
This is a prospective birth cohort study assessing the role of maternal and environmental factors on the development of allergic diseases in children. Pregnant mothers will be enrolled and we will examine her skin barrier with skin tape strips (STS) and transepidermal water loss (TEWL), along with blood work. We will then follow her offspring and perform similar testing, along with detailed questionnaires inquiring about exposures such as use of detergents and soaps, sunlight exposure, and pollution exposure. When the infant is around 12 months old, we will contact the family via telephone to see if the child developed any allergic conditions within their first year of life, such as eczema, food allergy, or wheezing. A final questionnaire will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with expected delivery in the fall or winter | – | Diagnostic Test: Transepidermal water loss, Diagnostic Test: Skin tape stripping, Diagnostic Test: Blood draw, Diagnostic Test: Bacterial PCR swabWe will enroll up to 40 women who are expected to deliver in the fall (September, October, November) and winter (December, January, February). We will then follow their infant offspring. |
| Pregnant women with expected delivery in the spring or summer | – | Diagnostic Test: Transepidermal water loss, Diagnostic Test: Skin tape stripping, Diagnostic Test: Blood draw, Diagnostic Test: Bacterial PCR swabWe will enroll up to 40 women who are expected to deliver in the spring (March, April, May) and summer (June, July, August). We will then follow their infant offspring. |
| Infants born in the fall or winter | – | Diagnostic Test: Transepidermal water loss, Diagnostic Test: Skin tape stripping, Diagnostic Test: Blood draw, Diagnostic Test: Bacterial PCR swabThe infants born to the enrolled mothers will be followed. These are infants born in the fall (September, October, November) or winter (December, January, February). |
| Infants born in the spring or summer | – | Diagnostic Test: Transepidermal water loss, Diagnostic Test: Skin tape stripping, Diagnostic Test: Blood draw, Diagnostic Test: Bacterial PCR swabThe infants born to the enrolled mothers will be followed. These are infants born in the spring (March, April, May) or summer (June, July, August). |
Who may qualify
- Ages
- 0 minutes to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- We will enroll up to 40 pregnant mothers who are expected to deliver in the fall and winter, along with up to 40 pregnant mothers who are expected to deliver in the spring and summer. The infants will then be enrolled and followed in the study.
Key inclusion criteria (2 listed)
- Pregnant women at any stage of a singleton pregnancy.
- Infant is the offspring of a woman enrolled in the study.
Key exclusion criteria (15 listed)
- Use of systemic immunosuppressive drugs including oral steroids within 30 days of skin barrier assessment
- Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30 days of skin barrier assessment
- Use of topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment
- Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days, or antihistamines within 5 days of skin barrier assessment
- Has taken a bleach bath within 7 days of skin barrier assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transepidermal water lossAlso: TEWLWe will assess the skin with transepidermal water loss (TEWL) by using a condenser-chamber system placed lightly on the skin. This will be performed at baseline, then after every 4 skin tape strips. | Diagnostic test | Infants born in the fall or winter, Infants born in the spring or summer, Pregnant women with expected delivery in the fall or winter, Pregnant women with expected delivery in the spring or summer |
| Skin tape strippingAlso: STSAdhesive skin sampling discs will be pressed against the skin in a hairless location followed by lifting it free of the skin. The discs will be evaluated for lipid content, protein, and filaggrin byproducts in the collected skin sample. | Diagnostic test | Infants born in the fall or winter, Infants born in the spring or summer, Pregnant women with expected delivery in the fall or winter, Pregnant women with expected delivery in the spring or summer |
| Blood drawWe will draw blood to look at the vitamin D, total immunoglobulin E (IgE), and the filaggrin gene which is important in maintaining the skin barrier. | Diagnostic test | Infants born in the fall or winter, Infants born in the spring or summer, Pregnant women with expected delivery in the fall or winter, Pregnant women with expected delivery in the spring or summer |
| Bacterial PCR swabAlso: PCRSkin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus. | Diagnostic test | Infants born in the fall or winter, Infants born in the spring or summer, Pregnant women with expected delivery in the fall or winter, Pregnant women with expected delivery in the spring or summer |
Primary outcome
Skin barrier assessment with transepidermal water loss (TEWL) will be done in every infant.
Time frame: 1 year
TEWL will be performed in all infants to compare skin barrier assessments between infants born in the fall and winter with those born in the spring and summer. We hypothesize greater skin barrier dysfunction in those born in the fall and winter.
Skin barrier assessment with skin tape stripping (STS) will be done in every infant.
Time frame: 1 year
STS will be performed in all infants to compare skin barrier assessments between infants born in the fall and winter with those born in the spring and summer. We hypothesize greater skin barrier dysfunction in those born in the fall and winter.
Skin barrier assessment with skin swabs for staphylococcus aureus colonization will be done in every infant.
Time frame: 1 year
Skin swabs for staphylococcus aureus colonization will be performed in all infants to compare skin barrier assessments between infants born in the fall and winter with those born in the spring and summer. We hypothesize greater staphylococcus aureus colonization in those born in the fall and winter.
Skin barrier assessment with TEWL will be performed in every pregnant female and compared to her infant offspring, as well as between other pregnant females giving birth in other seasons.
Time frame: 1 year
We will compare the mother's skin barrier with the infant skin barrier to see if there is an association with the mother's skin barrier during pregnancy. We will perform TEWL to assess the degree of water loss before, during, and after skin tape stripping.
Skin barrier assessment with STS will be performed in every pregnant female and compared to her infant offspring, as well as between other pregnant females giving birth in other seasons.
Time frame: 1 year
We will compare the mother's skin barrier with the infant skin barrier to see if there is an association with the mother's skin barrier during pregnancy. We will perform STS to determine the skin breakdown products.
Skin barrier assessment with skin swabs for staphylococcus aureus colonization will be performed in every pregnant female and compared to her infant offspring, as well as between other pregnant females giving birth in other seasons.
Time frame: 1 year
We will compare the mother's skin barrier with the infant skin barrier to see if there is an association with the mother's skin barrier during pregnancy. We will perform skin swabs for staphylococcus aureus colonization to determine the presence of colonization.
Skin barrier assessment with filaggrin gene mutation status will be determined in everyone enrolled, and we will look for the filaggrin gene mutation in both the mother and infant.
Time frame: 1 year
The filaggrin gene is important for skin health, and we will assess for common filaggrin gene mutations in everyone enrolled in this study via a blood draw in the mother's and cord blood in the infants.
Vitamin D levels will be obtained and compared between individuals enrolled in this study.
Time frame: 1 year
Vitamin D levels will be obtained by blood draw in the pregnant mother's and cord blood in the infants. We will compare the values according to season of birth, as we hypothesize that the infants born in the fall and winter, along with their mothers, will have a lower vitamin D level.
Questionnaires regarding exposures will be compared with the skin barrier measurements to understand exposures that lead to increased skin barrier dysfunction.
Time frame: 1 year
Questionnaires will be administered to capture exposures during pregnancy, such as detergents, soaps, medications, and sunlight exposure. The answers will be compared with the results of the skin barrier assessment in both pregnant women and their infants to understand which exposures lead to skin barrier dysfunction.
Questionnaires and a follow up telephone call will allow us to see if infants born in the fall and winter have a higher incidence of allergy development.
Time frame: 1 year
Questionnaires and follow up telephone calls when the infant is 12 months old will determine which infants develop allergic conditions, such as atopic dermatitis, food allergy, and wheezing. We will compare the infants born in the fall and winter with those born in the spring and summer to see whether the infants born in the fall and winter have increased risk of developing allergy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Donald Leung, MD PhD principal investigator
National Jewish Health
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 Pregnancy Related and Allergy, run by National Jewish Health 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 10 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica W Hui, MD (3033981245, huij@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin barrier assessment with transepidermal water loss (TEWL) will be done in every infant. (time frame: 1 year). The study lists 10 primary outcomes in all. 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 10 Sep 2020.