NCT04445298

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

April 29, 2020

Last Update Submit

September 8, 2020

Conditions

Pregnancy RelatedAllergyAtopic Dermatitis EczemaAsthma in ChildrenFood Allergy

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

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 lossDiagnostic Test: Skin tape strippingDiagnostic Test: Blood drawDiagnostic Test: Bacterial PCR swab

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 lossDiagnostic Test: Skin tape strippingDiagnostic Test: Blood drawDiagnostic Test: Bacterial PCR swab

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 lossDiagnostic Test: Skin tape strippingDiagnostic Test: Blood drawDiagnostic Test: Bacterial PCR swab

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 lossDiagnostic Test: Skin tape strippingDiagnostic Test: Blood drawDiagnostic Test: Bacterial PCR swab

Interventions

Transepidermal water lossDIAGNOSTIC_TEST

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.

Also known as: TEWL
Infants born in the fall or winterInfants born in the spring or summerPregnant women with expected delivery in the fall or winterPregnant women with expected delivery in the spring or summer
Skin tape strippingDIAGNOSTIC_TEST

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.

Also known as: STS
Infants born in the fall or winterInfants born in the spring or summerPregnant women with expected delivery in the fall or winterPregnant women with expected delivery in the spring or summer
Blood drawDIAGNOSTIC_TEST

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.

Infants born in the fall or winterInfants born in the spring or summerPregnant women with expected delivery in the fall or winterPregnant women with expected delivery in the spring or summer
Bacterial PCR swabDIAGNOSTIC_TEST

Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.

Also known as: PCR
Infants born in the fall or winterInfants born in the spring or summerPregnant women with expected delivery in the fall or winterPregnant women with expected delivery in the spring or summer

Eligibility Criteria

Age0 Minutes - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Pregnant women at any stage of a singleton pregnancy.
  • Infant is the offspring of a woman enrolled in the study.

You may not qualify if:

  • 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
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will obtain blood to assess the filaggrin gene mutation status, as filaggrin gene mutations have been associated with increased atopic dermatitis severity and persistence. Other blood work includes total immunoglobulin E and vitamin D.

MeSH Terms

Conditions

HypersensitivityFood Hypersensitivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System DiseasesHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Donald Leung, MD PhD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica W Hui, MD

CONTACT

3033981245huij@njhealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

June 24, 2020

Study Start

August 3, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

US(1)