<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04445298</url>
  </required_header>
  <id_info>
    <org_study_id>HS3513</org_study_id>
    <nct_id>NCT04445298</nct_id>
  </id_info>
  <brief_title>Skin Barrier Assessment in Pregnancy and at Birth</brief_title>
  <official_title>Skin Barrier Assessment in Pregnancy and at Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Jewish Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Jewish Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective birth cohort study assessing the role of maternal and environmental&#xD;
      factors on the development of allergic diseases in children. Pregnant mothers will be&#xD;
      enrolled and we will examine her skin barrier with skin tape strips (STS) and transepidermal&#xD;
      water loss (TEWL), along with blood work. We will then follow her offspring and perform&#xD;
      similar testing, along with detailed questionnaires inquiring about exposures such as use of&#xD;
      detergents and soaps, sunlight exposure, and pollution exposure. When the infant is around 12&#xD;
      months old, we will contact the family via telephone to see if the child developed any&#xD;
      allergic conditions within their first year of life, such as eczema, food allergy, or&#xD;
      wheezing. A final questionnaire will be performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Skin barrier assessment with transepidermal water loss (TEWL) will be done in every infant.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin barrier assessment with skin tape stripping (STS) will be done in every infant.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin barrier assessment with skin swabs for staphylococcus aureus colonization will be done in every infant.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin D levels will be obtained and compared between individuals enrolled in this study.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaires regarding exposures will be compared with the skin barrier measurements to understand exposures that lead to increased skin barrier dysfunction.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Allergy</condition>
  <condition>Atopic Dermatitis Eczema</condition>
  <condition>Asthma in Children</condition>
  <condition>Food Allergy</condition>
  <arm_group>
    <arm_group_label>Pregnant women with expected delivery in the fall or winter</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregnant women with expected delivery in the spring or summer</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants born in the fall or winter</arm_group_label>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants born in the spring or summer</arm_group_label>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transepidermal water loss</intervention_name>
    <description>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.</description>
    <arm_group_label>Infants born in the fall or winter</arm_group_label>
    <arm_group_label>Infants born in the spring or summer</arm_group_label>
    <arm_group_label>Pregnant women with expected delivery in the fall or winter</arm_group_label>
    <arm_group_label>Pregnant women with expected delivery in the spring or summer</arm_group_label>
    <other_name>TEWL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Skin tape stripping</intervention_name>
    <description>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.</description>
    <arm_group_label>Infants born in the fall or winter</arm_group_label>
    <arm_group_label>Infants born in the spring or summer</arm_group_label>
    <arm_group_label>Pregnant women with expected delivery in the fall or winter</arm_group_label>
    <arm_group_label>Pregnant women with expected delivery in the spring or summer</arm_group_label>
    <other_name>STS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>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.</description>
    <arm_group_label>Infants born in the fall or winter</arm_group_label>
    <arm_group_label>Infants born in the spring or summer</arm_group_label>
    <arm_group_label>Pregnant women with expected delivery in the fall or winter</arm_group_label>
    <arm_group_label>Pregnant women with expected delivery in the spring or summer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Bacterial PCR swab</intervention_name>
    <description>Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.</description>
    <arm_group_label>Infants born in the fall or winter</arm_group_label>
    <arm_group_label>Infants born in the spring or summer</arm_group_label>
    <arm_group_label>Pregnant women with expected delivery in the fall or winter</arm_group_label>
    <arm_group_label>Pregnant women with expected delivery in the spring or summer</arm_group_label>
    <other_name>PCR</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We will obtain blood to assess the filaggrin gene mutation status, as filaggrin gene&#xD;
      mutations have been associated with increased atopic dermatitis severity and persistence.&#xD;
&#xD;
      Other blood work includes total immunoglobulin E and vitamin D.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will enroll up to 40 pregnant mothers who are expected to deliver in the fall and&#xD;
        winter, along with up to 40 pregnant mothers who are expected to deliver in the spring and&#xD;
        summer. The infants will then be enrolled and followed in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria of the pregnant women:&#xD;
&#xD;
        • Pregnant women at any stage of a singleton pregnancy.&#xD;
&#xD;
        Inclusion criteria of the infant:&#xD;
&#xD;
        • Infant is the offspring of a woman enrolled in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria of all subjects:&#xD;
&#xD;
          -  Use of systemic immunosuppressive drugs including oral steroids within 30 days of skin&#xD;
             barrier assessment&#xD;
&#xD;
          -  Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen plus&#xD;
             ultraviolet light A [PUVA], tanning beds [&gt;1 visit per week]) within 30 days of skin&#xD;
             barrier assessment&#xD;
&#xD;
          -  Use of topical corticosteroids, topical immunomodulatory agents, or topical&#xD;
             antibiotics on the extremity being evaluated within 7 days of skin barrier assessment&#xD;
&#xD;
          -  Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days,&#xD;
             or antihistamines within 5 days of skin barrier assessment&#xD;
&#xD;
          -  Has taken a bleach bath within 7 days of skin barrier assessment&#xD;
&#xD;
          -  Use of emollients on the extremity being evaluated within 24 hours of skin barrier&#xD;
             assessment&#xD;
&#xD;
          -  Has taken a bath or shower on the day of the skin barrier assessment&#xD;
&#xD;
        Exclusion criteria of the pregnant women:&#xD;
&#xD;
          -  Pregnant women with high risk pregnancies.&#xD;
&#xD;
          -  Pregnancy is from an egg donation.&#xD;
&#xD;
          -  Pregnant women pregnant with more than one fetus.&#xD;
&#xD;
          -  Pregnant women with psychiatric and developmental co-morbidities that would render&#xD;
             them unable to provide informed consent or perform study-related procedures.&#xD;
&#xD;
          -  AIDS and HIV infection.&#xD;
&#xD;
          -  A fetus with chromosomal or congenital abnormalities, a heritable hematological&#xD;
             disorder like thalassemia or sickle cell disease in the mother.&#xD;
&#xD;
        Exclusion criteria of the infant:&#xD;
&#xD;
          -  Infant is delivered earlier than 34 weeks gestation.&#xD;
&#xD;
          -  Infant is born with a significant birth defect or medical condition where enrollment&#xD;
             in this study is not in the infant's best interest.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Minutes</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donald Leung, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Jewish Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jessica W Hui, MD</last_name>
    <phone>3033981245</phone>
    <email>huij@njhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Hui, MD</last_name>
      <email>huij@njhealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>April 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04445298
org study id: HS3513
nct id: NCT04445298
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Skin barrier assessment with transepidermal water loss (TEWL) will be done in every infant.
time frame: 1 year
description: 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.
measure: Skin barrier assessment with skin tape stripping (STS) will be done in every infant.
time frame: 1 year
description: 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.
measure: Skin barrier assessment with skin swabs for staphylococcus aureus colonization will be done in every infant.
time frame: 1 year
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: Vitamin D levels will be obtained and compared between individuals enrolled in this study.
time frame: 1 year
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
arm group label: Pregnant women with expected delivery in the fall or winter
description: 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.
arm group label: Pregnant women with expected delivery in the spring or summer
description: 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.
arm group label: Infants born in the fall or winter
description: 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).
arm group label: Infants born in the spring or summer
description: 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).
intervention type: Diagnostic Test
intervention name: Transepidermal water loss
description: 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.
arm group label: Infants born in the fall or winter
arm group label: Infants born in the spring or summer
arm group label: Pregnant women with expected delivery in the fall or winter
arm group label: Pregnant women with expected delivery in the spring or summer
other name: TEWL
intervention type: Diagnostic Test
intervention name: Skin tape stripping
description: 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.
arm group label: Infants born in the fall or winter
arm group label: Infants born in the spring or summer
arm group label: Pregnant women with expected delivery in the fall or winter
arm group label: Pregnant women with expected delivery in the spring or summer
other name: STS
intervention type: Diagnostic Test
intervention name: Blood draw
description: 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.
arm group label: Infants born in the fall or winter
arm group label: Infants born in the spring or summer
arm group label: Pregnant women with expected delivery in the fall or winter
arm group label: Pregnant women with expected delivery in the spring or summer
intervention type: Diagnostic Test
intervention name: Bacterial PCR swab
description: Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.
arm group label: Infants born in the fall or winter
arm group label: Infants born in the spring or summer
arm group label: Pregnant women with expected delivery in the fall or winter
arm group label: Pregnant women with expected delivery in the spring or summer
other name: PCR
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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Minutes
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Donald Leung, MD PhD
role: Principal Investigator
affiliation: National Jewish Health
last name: Jessica W Hui, MD
phone: 3033981245
email: huij@njhealth.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
sharing ipd: Undecided