跳至主要内容
临床试验/NCT06286813
NCT06286813招募中不适用

The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit

Marmara University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2024年3月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Neonatal skin condition score

研究概览

简要总结

This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.

Interventional research with two parallel groups and no control group

详细描述

The study was conducted in the Neonatal intensive care unit (NICU) of a training and research hospital.The total number of infants admitted to the NICU was 28. Each nurse is responsible for the care of 3 or 4 newborn babies.

Skin are routines in the NICU: A skin condition assessment score is routinely performed every day (09.00 am) in all infants and moisturizing products are used for their skin care. Therefore, there was no control group in the study.

Extra virgin olive oil and almond oil are among the skin care products used in the clinic routines. Therefore, the effects of the currently used oils were compared in the study

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 Hour 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates who were born at 37-42 weeks of gestation, were planned to be hospitalized in the NICU for at least 5 days, had a post-natal age of 0-72 hours, and were received written and verbal consent from parents were included in the study.

排除标准

  • ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.

研究组 & 干预措施

Almond oil group

Experimental

On the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., almond oil (10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days.

干预措施: Plant (natural) oils (Other)

Extra Virgin Olive Oil Group

Experimental

On the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., extra virgin olive oil(10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days.

干预措施: Plant (natural) oils (Other)

结局指标

主要结局

Neonatal skin condition score

时间窗: 5 days

This is a three-point Likert-type scale to evaluate dryness, redness, peeling / deterioration in newborn baby skin. For each criterion in the evaluation of the scale score; 1 refers to the best and 3 to the worst skin condition. The highest and lowest scores on the scale are 9 and 3, respectively. A higher scale score indicates poorer skin condition

Skin moisture meter(DMM):

时间窗: 5 days

The product shows the moisture level (0%-99.9%) in contact with the skin and does not harm the skin. It provides measurement results with high precision

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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