NCT04445298

Skin Barrier Assessment in Pregnancy and at Birth

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: National Jewish Health · Academic / Other
• Sex: All
• Age: 0 Minutes – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2020-08-03
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-06-24
• Last updated: 2020-09-10

Locations

1 site across 1 country: United States