Status:
UNKNOWN
Skin Barrier Assessment in Pregnancy and at Birth
Lead Sponsor:
National Jewish Health
Conditions:
Pregnancy Related
Allergy
Eligibility:
All Genders
Up to 55 years
Brief 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 exa...
Eligibility Criteria
Inclusion
- Inclusion criteria of the pregnant women:
- • Pregnant women at any stage of a singleton pregnancy.
- Inclusion criteria of the infant:
- • Infant is the offspring of a woman enrolled in the study.
Exclusion
- Exclusion criteria of all subjects:
- 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
- Has taken a bath or shower on the day of the skin barrier assessment
- Exclusion criteria of the pregnant women:
- 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.
- Exclusion criteria of the infant:
- 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.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04445298
Start Date
August 3 2020
End Date
July 1 2022
Last Update
September 10 2020
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206