Clinical trial NCT04445298: Skin Barrier Assessment in Pregnancy and at Birth
Official title: Skin Barrier Assessment in Pregnancy and at Birth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Allergy
Atopic Dermatitis Eczema
Asthma in Children
Food Allergy
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 160
Sex: ALL
Minimum age (years): 0
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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 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.


Eligibility criteria: Inclusion Criteria:

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 Criteria:

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.

Primary outcomes:
measure: Skin barrier assessment with transepidermal water loss (TEWL) will be done in every infant.
timeFrame: 1 year
measure: Skin barrier assessment with skin tape stripping (STS) will be done in every infant.
timeFrame: 1 year
measure: Skin barrier assessment with skin swabs for staphylococcus aureus colonization will be done in every infant.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: Vitamin D levels will be obtained and compared between individuals enrolled in this study.
timeFrame: 1 year
measure: Questionnaires regarding exposures will be compared with the skin barrier measurements to understand exposures that lead to increased skin barrier dysfunction.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Donald Leung, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: