Expired Study
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St. Louis, Missouri 63110


Purpose:

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.


Study summary:

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.


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 is Available At:


Original ID:

ECP-005


NCT ID:

NCT01342133


Secondary ID:


Study Acronym:


Brief Title:

Sweat Duct Imaging in Mother/Newborn Dyads


Official Title:

Sweat Duct Imaging in Mother/Newborn Dyads


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Edimer Pharmaceuticals


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lisa Moscoso, MD, PhD
Principal Investigator
Washington University School of Medicine

Study Dates

Start Date:April 2011
Completion Date:July 2011
Completion Type:Actual
Primary Completion Date:April 2011
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 26, 2012
First Received Date:April 22, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns
Time Frame:Day 1
Safety Issues:False
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
Outcome Type:Primary Outcome
Measure: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
Time Frame:Day 1
Safety Issues:False
Description:These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Newborns
Study Arm Type:Other
Arm Name:Mothers

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Edimer Pharmaceuticals

Samples and Retentions

Study Population: The study will enroll up to twenty healthy term newborns and their mothers in the Assessment Nursery at Barnes-Jewish Hospital.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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