Skin Barrier Assessment in Pregnancy and at Birth

September 8, 2020 updated by: National Jewish Health
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will enroll up to 40 pregnant mothers who are expected to deliver in the fall and winter, along with up to 40 pregnant mothers who are expected to deliver in the spring and summer. The infants will then be enrolled and followed in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other Names:
  • TEWL
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.
Other Names:
  • STS
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.
Other Names:
  • PCR
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.
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.
Other Names:
  • TEWL
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.
Other Names:
  • STS
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.
Other Names:
  • PCR
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).
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.
Other Names:
  • TEWL
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.
Other Names:
  • STS
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.
Other Names:
  • PCR
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).
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.
Other Names:
  • TEWL
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.
Other Names:
  • STS
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.
Other Names:
  • PCR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin barrier assessment with transepidermal water loss (TEWL) will be done in every infant.
Time Frame: 1 year
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
Skin barrier assessment with skin tape stripping (STS) will be done in every infant.
Time Frame: 1 year
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
Skin barrier assessment with skin swabs for staphylococcus aureus colonization will be done in every infant.
Time Frame: 1 year
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
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.
Time Frame: 1 year
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
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.
Time Frame: 1 year
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
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.
Time Frame: 1 year
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
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.
Time Frame: 1 year
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
Vitamin D levels will be obtained and compared between individuals enrolled in this study.
Time Frame: 1 year
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
Questionnaires regarding exposures will be compared with the skin barrier measurements to understand exposures that lead to increased skin barrier dysfunction.
Time Frame: 1 year
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
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.
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Jewish Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donald Leung, MD PhD, National Jewish Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS3513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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