Effect of Using Oxygen on the Diaper Dermatitis in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Diaper dermatitis healing scale result
研究概览
简要总结
Background: Airing the diaper area has a positive effect on dermatitis. In addition, it is reported in the literature that oxygen is effective in wound care. The aim of our study is to investigate the effect of oxygen on infant diaper dermatitis.
Method: The study population consisted of infants will admit to the neonatal intensive care unit of a public hospital in Istanbul between October 2022 and April 2023. Sixty newborns who met the study criteria will randomly divide into two as the experimental (n=30) and control (n=30) groups. Personal data form and diaper dermatitis observation form will be used to obtain the data. All babies' diapers will be changed 8 times a day. Oxygen flow will be applied to the experimental group for one hour after each diaper change. The degree of diaper dermatitis will be evaluated every 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Approved by the family for the study
- •Born between 34-
- •gestational weeks
- •No skin disease other than diaper dermatitis
- •No skin lesions of another disease other than dermatitis-related lesions in the gland area
- •Newborns who has stable vital signs
排除标准
- •Having a skin disease other than diaper dermatitis
- •Having a lesion on the skin due to another disease
- •Having a known skin allergy
- •Born before
- •gestational weeks
- •Having a gastrointestinal disease
研究组 & 干预措施
Oxygen Group
After the baby's diaper is changed, an oxygen hose placed inside the diaper will provide free oxygen flow to the diaper area.
Oxygen will be applied for 1 hour at each diaper change at a flow rate of 5L/min and at a concentration of 21% FiO2 which is equivalent to room air.
干预措施: Oxygen (Drug)
结局指标
主要结局
Diaper dermatitis healing scale result
时间窗: 72 hours
Expecting to healing diaper dermatitis symptoms at the time of intervention. The scale maximum value: 6 and minimum value: 0. As the scale score increases, the severity of dermatitis increases.
次要结局
未报告次要终点
研究者
Elif Dogan
Principal Investigator
Istanbul University - Cerrahpasa (IUC)