Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2020-08-03
2022-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Transepidermal water loss
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 stripping
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 draw
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 swab
Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.
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.
Transepidermal water loss
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 stripping
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 draw
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 swab
Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.
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).
Transepidermal water loss
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 stripping
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 draw
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 swab
Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.
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).
Transepidermal water loss
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 stripping
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 draw
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 swab
Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.
Interventions
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Transepidermal water loss
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 stripping
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 draw
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 swab
Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
• Infant is the offspring of a woman enrolled in the study.
Exclusion Criteria
* 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
* 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.
0 Minutes
55 Years
ALL
Yes
Sponsors
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National Jewish Health
OTHER
Responsible Party
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Principal Investigators
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Donald Leung, MD PhD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Locations
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National Jewish Health
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS3513
Identifier Type: -
Identifier Source: org_study_id
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