Efficacy of Breast Milk in Healing of Skin Damage Due to Tape Peeling in Premature Babies: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- skin damage
研究概览
简要总结
The population of the research will be preterm infants born 35-36 weeks of gestation, hospitalized in the Neonatal Intensive Care Unit of Karaman State Hospital, whose skin is damaged due to Intravenous (IV) vascular access fixation bands, and whose skin has not been subjected to any other application before. Calculation of the sample number of the research; It was determined that at least 24 newborns should be assigned to each group (α = 0.05 and β = 0.19) to show that the 1 degree difference between the cream group and the breast milk group was significant for 80.7% strength. It is planned to take a premature baby. As data collection tools, Premature Babies Descriptive Information Form, Newborn Skin Condition Assessment Scale, Medical Adhesives and Solvents Used in the Neonatal Intensive Care Unit, Human Milk and routine care will be used.
详细描述
Randomization The process of inclusion of newborns into groups will be randomly assigned using the computer program (https://www.randomizer.org). Which letter will be the breast milk or routine care group was determined by the closed opaque envelope method at the beginning of the study. Accordingly, the letter A will be used for the breast milk group and the letter B will be used for the cream group. According to the black bag drawn randomly by an independent nurse from the research, which group it will be in will be determined.
Hypotheses H1: The use of topical breast milk is more effective than the routine care in the healing of skin damage due to tape stripping, which is used in the detection of IV vascular access in premature babies.
H2: The use of routine care is more effective than topical breast milk in the healing of skin damage due to tape stripping, which is used in the detection of IV vascular access in premature babies.
Variables of the Study Dependent variables: Scores from the newborns' "Neonatal Skin Condition Assessment Scale".
Independent variables: Sociodemographic characteristics, two different methods including breast milk and routine care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written and verbal consent of the parents,
- •The newborn is less than 37 weeks of gestation,
- •Being in the Neonatal Intensive Care Unit,
- •The intravenous catheter has been fixed to the skin with a silk patch,
- •For intravenous catheter fixation, the bands remain on the skin for a minimum of 24 hours and a maximum of 32 hours,
- •While removing the adhesive tape, remove it slowly and carefully by softening the tape with cotton moistened with water,
- •The parent speaks and understands Turkish comfortably,
- •Stable health status
- •Having spontaneous breathing
- •Not being exposed to a painful procedure at least half an hour before the interventions.
- •Not taking opioid or non-opioid analgesics
- •Not receiving any antibiotic treatment,
- •Having breast milk
排除标准
- •Parent's inability to speak and understand Turkish easily,
- •Parents do not give written and verbal consent,
- •Intravenous catheter not fixed to the skin with a silk patch,
- •For intravenous catheter fixation, the bands should not remain on the skin for a minimum of 24 hours and a maximum of 32 hours,
- •Removal of the intravenous catheter from the skin using a solvent solution,
- •Having ventilator support
- •Presence of congenital anomaly
- •Using analgesic / narcotic analgesic drugs
- •Receiving any antibiotic treatment,
- •Continuous sedative treatment
- •Discontinuation of topical breast milk or cream application procedure for any reason
- •Parent's wish to leave the study
结局指标
主要结局
skin damage
时间窗: 3 weeks
The change in skin damage after the intervention with newborn skin condition assessment scalewill be monitored.
次要结局
未报告次要终点
研究者
Ayse Sonay Turkmen, Prof.Dr
Prof.Dr
Karamanoğlu Mehmetbey University