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临床试验/NCT06246864
NCT06246864尚未招募不适用

Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies

Ondokuz Mayıs University0 个研究点目标入组 60 人开始时间: 2024年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Newborn Skin Condition Score

研究概览

简要总结

While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams, hydrogel dressings, hydrocolloid dressings).

This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

详细描述

Many interventions are applied to premature babies in neonatal intensive care units due to the developing technologies in recent years. Babies in neonatal intensive care need many devices to maintain their vital functions and monitor the treatment process. The medical adhesive materials to be selected are important in determining the medical devices used in neonatal intensive care units, especially premature babies.

This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

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
Single (Participant)

入排标准

年龄范围
32 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • A newborn is a baby born between 32-36 weeks of gestation
  • No medical adhesive tape should be applied to the newborn's lips beforehand.
  • The newborn does not have any skin diseases
  • OG will be inserted into the newborn for the first time
  • Having a newborn receiving respiratory support with non-invasive mechanical ventilation, hood or free oxygen

排除标准

  • The newborn is not a baby born between 32-36 weeks of gestation
  • Applying medical adhesive tape on the newborn's lips beforehand
  • The newborn has any skin disease
  • OG has been inserted into the newborn before and detected.
  • Supporting and detecting the newborn's breathing by intubating it

结局指标

主要结局

Newborn Skin Condition Score

时间窗: The patch will be removed 24 hours after orogastric detection and a skin evaluation will be performed immediately.

NSCS allows evaluation of the newborn's skin condition. It evaluates skin dryness, redness and integrity, which are the basic characteristics of the newborn's skin. The scale consists of three parameters.

次要结局

未报告次要终点

研究者

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

Esra TURAL BUYUK

Associate Professor

Ondokuz Mayıs University

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