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临床试验/NCT04720989
NCT04720989已完成不适用

The Effect of Cleansing Product Used in the First Bathing on Transepidermal Water Loss and Skin Ph in Late Preterm and Term Infants: A Multicenter, Evaluative Blind Randomized Controlled Study

Akdeniz University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Transepidermal Water Loss

研究概览

简要总结

The aim of this study is to determine the effect of the newborn's first bath with a cleaning product and only water on the barrier function of the skin.

详细描述

Studies in the literature on the effects of newborn bath types on the effects of body temperature on newborn crying times, on the effects of newborn behavior and stress, the views and practices of mothers with newborn babies on baby bathing, and the effects of bath types on the umbilical cord in term babies, and the effects of bath products on newborns. It seems that there are studies done. However, although studies on the effect of the cleaning product used in the first bath of late preterm and term newborns on the skin barrier are limited in number for term newborns, there are almost no studies for late preterm newborns. The hypotheses of this study are as follows; 1. In late preterm and term newborns, the first bath with cleaning product protects the newborns' Transepidermal Fluid Loss better than the first bath with only water. 2. In late preterm and term newborns, the first bath with cleansing product keeps the skin pH levels of newborns at a more optimal level compared to the first bath with only water.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
34 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Born between 34 weeks + 0 days and 42 weeks + 6 days (late preterm and term),
  • With a body weight of 1800g or more,
  • Spontaneous breathing,
  • Preterms with stable physiological parameters will be included in the study.

排除标准

  • Receiving mechanical ventilation support,
  • Mother's baby with HIV, Hepatitis B,
  • Preterms who had a bath before the intervention,
  • Surgical operation and incision in any area,
  • Preterms with a central catheter,
  • Preterms with systemic infections,
  • Preterms using sedatives and / or muscle relaxants,
  • Preterms with congenital or chromosomal anomalies

结局指标

主要结局

Transepidermal Water Loss

时间窗: Change from Baseline (10 minutes before first bathing) Transepidermal Water Loss at 10 minutes and 30 minutes after bathing.

Among the outcome criteria, the skin barrier function will be evaluated first. Skin barrier function will be evaluated by measuring Transepidermal Water Loss (TESK). To measure transepidermal water loss, it will be measured by closed chamber evaporation using VapoMeter SWL-2 ™ (Delfin Technologies Ltd).

次要结局

  • Skin pH Level(Change from Baseline (10 minutes before first bathing) skin pH at 10 minutes and 30 minutes after bathing.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Halil Ibrahim Tasdemir

Research Assistant, Doctoral Candidate

Akdeniz University

研究点 (2)

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