Sweat Duct Imaging in Mother/Newborn Dyads

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Brief Title

Sweat Duct Imaging in Mother/Newborn Dyads

Official Title

Sweat Duct Imaging in Mother/Newborn Dyads

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.
    


Study Type

Observational


Primary Outcome

Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns


Condition

X-Linked Hypohidrotic Ectodermal Dysplasia


Study Arms / Comparison Groups

 Newborns
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

28

Start Date

April 2011

Completion Date

July 2011

Primary Completion Date

April 2011

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Lisa Moscoso, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01342133

Organization ID

ECP-005


Responsible Party

Sponsor

Study Sponsor

Edimer Pharmaceuticals


Study Sponsor

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


Verification Date

June 2012