Skin Barrier Assessment in Pregnancy and at Birth

Pregnancy Related Clinical Trial

Official title:

Skin Barrier Assessment in Pregnancy and at Birth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04445298
• Other study ID #: HS3513
• Status: Recruiting
• Start date: August 3, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2020
• Source: National Jewish Health
• Contact: Jessica W Hui, MD
• Phone: 3033981245
• Email: huij[@]njhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy
• Asthma in Children
• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Pregnancy Related

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year