Skin Barrier Assessment in Pregnancy and at Birth

National Jewish Health

Status: Unknown

Conditions: Food Allergy; Asthma in Children; Pregnancy Related; Atopic Dermatitis Eczema; Allergy

Treatments: Diagnostic Test: Bacterial PCR swab; Diagnostic Test: Blood draw; Diagnostic Test: Skin tape stripping; Diagnostic Test: Transepidermal water loss

Study type: Observational

Funder types: Other

Identifiers

NCT04445298

HS3513

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: Under 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

160 participants in 4 patient groups

Pregnant women with expected delivery in the fall or winter

Description:

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.

Treatment:

Diagnostic Test: Transepidermal water loss

Diagnostic Test: Blood draw

Diagnostic Test: Skin tape stripping

Diagnostic Test: Bacterial PCR swab

Pregnant women with expected delivery in the spring or summer

Description:

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.

Treatment:

Diagnostic Test: Transepidermal water loss

Diagnostic Test: Blood draw

Diagnostic Test: Skin tape stripping

Diagnostic Test: Bacterial PCR swab

Infants born in the fall or winter

Description:

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).

Treatment:

Diagnostic Test: Transepidermal water loss

Diagnostic Test: Blood draw

Diagnostic Test: Skin tape stripping

Diagnostic Test: Bacterial PCR swab

Infants born in the spring or summer

Description:

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).

Treatment:

Diagnostic Test: Transepidermal water loss

Diagnostic Test: Blood draw

Diagnostic Test: Skin tape stripping

Diagnostic Test: Bacterial PCR swab