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临床试验/NCT01342133
NCT01342133已完成不适用

Sweat Duct Imaging in Mother/Newborn Dyads

Edimer Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Congenital abnormalities affecting skin, nails, or hair in the newborn infant
  • Family history of a sweating disorder

结局指标

主要结局

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

时间窗: Day 1

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

时间窗: Day 1

These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.

次要结局

未报告次要终点

研究者

发起方
Edimer Pharmaceuticals
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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