跳至主要内容
临床试验/NCT04972747
NCT04972747Unknown不适用

SBÜ Koceli Derince Eğitim ve Araştırma Hastanesi

Derince Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年10月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
2
主要终点
The effect of skin care applied with two different oils on skin integrity and growth parameters in premature babies

研究概览

简要总结

As a result of technological advances in the field of newborns, the survival rates of very young babies have increased. With this situation, there was a need to develop new evidence-based application areas in premature babies. Nurses provide evidence-based care in many areas to term and preterm babies in the neonatal intensive care unit. One of these areas is the skin, which is known as 13% of the newborn's body weight and constitutes the largest part of the organism. Before skin care is given, knowing the skin characteristics of the newborn and performing skin care in accordance with these features will provide more benefits for the baby. The skin of newborns is different from adults in terms of both function and function. In addition, skin characteristics of term and preterm babies also differ according to the week of delivery.

Skin basically enables the newborn to explore the world by thermoregulation, as a barrier against microorganisms and chemical harmful substances, maintaining fluid-electrolyte balance, vitamin D production, fat storage and sensory-touch. The immature skin of the newborn cannot fully fulfill these functions. In another study conducted between sunflower oil and the control group, it was stated that rash and peeling were less common in the sunflower oil experiment group compared to the control group.

As a result, evidence-based knowledge of nurses about neonatal skin care should be increased in neonatal intensive care units, and appropriate nursing care should be given especially to premature newborns who are at risk due to hospitalization. Even if there is no routine procedure in our service, baby oil is massaged during care hours, but there is no study on this. The aim of this study is to contribute to the neonatal skin care literature and to provide appropriate evidence-based care in the service routine.

详细描述

The research will be carried out with preterm babies hospitalized in the 3rd Level Neonatal Intensive Care Unit of SBÜ Kocaeli Derince Training and Research Hospital, Alikahya Campus and meeting the criteria of the study. Preterm babies with a birth weight of 1000 g and above, who do not receive ventilator support, and who do not have skin damage more than 5% of the body surface between 32-36 weeks of gestation will be included in the study. Two groups will be created by randomization method.

These groups are; Sunflower oil group: Babies to whom skin care will be applied with sunflower oil.

Coconut oil group: Babies who will be treated with coconut oil

After the premature babies who meet the study criteria are divided into groups and their consent is obtained, they will be followed up by the person conducting the study, and all applications will be carried out by the same person. Information about the newborn will be filled in by the person who will perform the application by using the "Form for Identifying the Introductory and Clinical Characteristics of the Newborn".

The application will be carried out twice a day during the maintenance hours of the service. In skin care applications, body baths are applied not more than three times a week, as it may cause hypothermia in preterm babies in the ward routine. In daily skin care, body cleaning with cotton, changing the fixation points such as orogastric probe, and changing the monitor probe locations are among the routine practices. In order to hydrate and moisturize the skin in preterm and term babies, baby oil in the service is used. Skin care applied in the service routine will be applied to the preterm babies included in the study, and only sunflower oil and coconut oil will be used as moisturizers.

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 (Investigator)

盲法说明

Babies meeting the criteria will be divided into two groups by randomization method. Randomization will be done by drawing lots using two red and blue cards. 31 red and 31 blue cards will be placed in an invisible purse. For the baby who meets the criteria, a card will be drawn by another nurse working in the clinic. Massage with sunflower oil will be applied for the baby with a red card, and skin care with coconut oil will be applied for the baby with a blue card.

入排标准

年龄范围
2 Days 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Parents' agreement to participate in the research
  • Preterm babies at 32-36 gestational week
  • 1000 gr and above preterm babies
  • Non-surgical infants are included.

排除标准

  • Skin damage may occur over 5% of the body surface
  • Preterm babies monitored on mechanical ventilation
  • Preterm babies receiving phototherapy

结局指标

主要结局

The effect of skin care applied with two different oils on skin integrity and growth parameters in premature babies

时间窗: one year

Neonatal Skin Condition Score-NSCS. The scale consists of three parameters. These; dryness, redness and deterioration of skin integrity/peeling. Each parameter is scored from one to three. The lowest score that can be obtained from the scale is 3, the highest score is 9, and a total score of 16 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
Derince Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yaprak Tokdemir

Principal Investigator

Derince Training and Research Hospital

研究点 (2)

Loading locations...

相似试验