Back to resultsSweat Duct Imaging in Mother/Newborn Dyads
Primary Purpose
X-Linked Hypohidrotic Ectodermal Dysplasia
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for X-Linked Hypohidrotic Ectodermal Dysplasia
Eligibility Criteria
Inclusion Criteria:
- Healthy term newborns (37-42 weeks gestation at delivery) in the Assessment Nursery at Barnes-Jewish Hospital, St. Louis, MO
- Mother of a healthy term newborn who is enrolled in this study
Exclusion Criteria:
- Congenital abnormalities affecting skin, nails, or hair in the newborn infant
- Family history of a sweating disorder
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
Newborns
Mothers
Arm Description
Outcomes
Primary Outcome Measures
Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns
To demonstrate the ease of use of a non-invasive confocal imaging device in the evaluation and measurement of sweat ducts on the plantar surface of healthy, term newborns. These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.
To assess the sweat duct density (i.e. the number of sweat ducts) in a 6 x 6 mm area on the plantar surface of healthy, term newborns, males and females, and the palmar surface of their mothers
These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01342133
Brief Title
Sweat Duct Imaging in Mother/Newborn Dyads
Official Title
Sweat Duct Imaging in Mother/Newborn Dyads
Study Type
Observational
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edimer Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device.
Detailed Description
In this exploratory study, the investigators propose to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device (Lucid Vivascope®). This approach has the potential to be valuable in repeated sweat endpoint assessments, as the device was selected based on its ease of use, the low risk to patients of all ages, and its ability to generate quantitative data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
X-Linked Hypohidrotic Ectodermal Dysplasia
7. Study Design
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Newborns
Arm Title
Mothers
Primary Outcome Measure Information:
Title
Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns
Description
To demonstrate the ease of use of a non-invasive confocal imaging device in the evaluation and measurement of sweat ducts on the plantar surface of healthy, term newborns. These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.
Time Frame
Day 1
Title
To assess the sweat duct density (i.e. the number of sweat ducts) in a 6 x 6 mm area on the plantar surface of healthy, term newborns, males and females, and the palmar surface of their mothers
Description
These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.
Time Frame
Day 1
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy term newborns (37-42 weeks gestation at delivery) in the Assessment Nursery at Barnes-Jewish Hospital, St. Louis, MO
Mother of a healthy term newborn who is enrolled in this study
Exclusion Criteria:
Congenital abnormalities affecting skin, nails, or hair in the newborn infant
Family history of a sweating disorder
Study Population Description
The study will enroll up to twenty healthy term newborns and their mothers in the Assessment Nursery at Barnes-Jewish Hospital.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Moscoso, MD, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dorothy K Grange, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
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Sweat Duct Imaging in Mother/Newborn Dyads
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