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Skin Barrier Assessment in Pregnancy and at Birth

NCT04445298 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2020-09-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Jewish Health

    lead OTHER

Principal Investigators

  • Donald Leung, MD PhD · National Jewish Health

Eligibility

Min Age
0 Minutes
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445298 on ClinicalTrials.gov