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临床试验/NCT07072130
NCT07072130已完成不适用

The Effect of Using Two Different Skin Cleansing Cotton Swabs on the Skin Condition of Term Newborns During Diaper Care for Meconium Removal

Acibadem University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
2
主要终点
Change in score of skin condition

研究概览

简要总结

The aim of this study was to determine the effect of two different skin cleansing cotton wipes on skin condition during meconium removal diaper care in term newborns.

The following hypotheses were tested: (a) There is no difference between the effect of using wet cotton and baby oil-impregnated skin cleansing cotton on skin condition during meconium removal diaper care in term newborns. (b) There is a difference between the effect of using wet cotton and baby oil-impregnated skin cleansing cotton on skin condition during meconium removal diaper care in term newborns.

详细描述

Newborns pass a substance called meconium in the first 24-48 hours through feces. Meconium is a sticky substance consisting of epithelial cells containing green, brown and dark colored mucus. Although meconium can be cleaned with soft tissue wipes that do not contain alcohol and odor or cotton soaked with water, it is difficult to clean because of its adhesive structure. Diaper care practices, wiping, rubbing procedures and materials used during care are important parameters that may threaten skin integrity and should be taken into consideration. In the literature, skin disorders in the diaper area are among the most common skin problems encountered by newborns in the first year. The skin of newborns is different from that of adults. The function of the epidermis is not yet complete and studies have reported that it continues to complete the maturation process in the first year of life.

However, the gland area in infants has higher hydration and pH levels than other areas. The change in skin pH affects the ionization level of molecules and topical absorption. Friction and prolonged exposure of this area to feces further increase the skin pH and potentiate the action of skin irritating fecal enzymes. Therefore, it is important to keep the diaper area clean at all times and maintain adequate hydration.

It is an important necessity to develop a special method for easier removal of meconium formed in the first days of life without damaging the skin integrity. In this study, skin condition score was evaluated by using wet cotton and baby oil-impregnated skin cleansing cotton during diaper care for meconium removal.

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
None

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns 38 gestational weeks and older
  • Healthy newborns
  • Newborns who defecate their first meconium

排除标准

  • Newborns with abnormal skin condition
  • Newborns with gastrointestinal tract disease
  • Newborns with parental history of skin disease
  • Newborns with developmental delay
  • Newborns with meconium defecation before the first skin assessment

结局指标

主要结局

Change in score of skin condition

时间窗: 1 hour after birth; immediately after the first meconium diaper care; 3 hours and 6 hours after the first meconium diaper care.The change in these time period will be measured.

Skin condition was measured using a validated and reliable skin condition score. The scale consists of three items and each item includes an evaluation criterion. These are dryness, erythema and disruption/peeling of skin integrity, respectively. Each item of the three-point Likert scale is scored from 1 to 3. The lowest score that can be obtained from the scale is 3 and the highest score is 9; a high total score indicates that the skin condition of the newborn is poor.

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra Kan Onturk

Assoc. Prof.

Acibadem University

研究点 (2)

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