Clinical Trials

Skin Barrier Assessment in Pregnancy and at Birth

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	0 Minutes - 55 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04445298
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Jewish Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Donald Leung, MD PhD
Principal Investigator Affiliation	National Jewish Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pregnancy Related, Allergy, Atopic Dermatitis Eczema, Asthma in Children, Food Allergy

Arms & Interventions

Arms

: Pregnant women with expected delivery in the fall or winter

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.

: Pregnant women with expected delivery in the spring or summer

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.

: Infants born in the fall or winter

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).

: Infants born in the spring or summer

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).

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Site Contact

Jessica Hui, MD

huij@njhealth.org

3033981245

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