Hydrocolloid Dressing for Diaper Dermatitis in NICU Hospitalized Neonates and Young Infants: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in diaper dermatitis severity score
研究概览
简要总结
Diaper dermatitis (commonly known as diaper rash) is one of the most frequent skin problems in newborns and infants, especially in neonatal intensive care units (NICUs). This study was designed to compare two treatment approaches for diaper dermatitis: hydrocolloid dressings and a cream containing 40% zinc oxide. The severity of diaper rash was evaluated at the beginning of treatment and at 24, 48, and 72 hours of follow-up.
详细描述
Diaper dermatitis (diaper rash) is a common skin problem in neonates and infants, often associated with prolonged exposure of the skin to moisture, urine, and stool. Infants hospitalized in neonatal intensive care units (NICUs) are particularly vulnerable due to frequent stools, immature skin, and exposure to irritants. This study was conducted to evaluate the effectiveness of hydrocolloid dressings compared with standard barrier cream containing 40% zinc oxide in the management of diaper dermatitis. A total of 44 infants hospitalized in a NICU and clinically diagnosed with diaper dermatitis were included. Infants were allocated into two groups: the intervention group received hydrocolloid dressings applied to the affected area, while the control group received zinc oxide cream. The severity of diaper dermatitis was assessed using a standardized clinical evaluation scale at baseline and at 24, 48, and 72 hours after initiation of the intervention. The primary aim was to compare changes in severity scores and healing time between the two treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization in the NICU
- •Body weight greater than 1000 g at the start of the intervention
- •Gestational age above 26 weeks
- •Diaper dermatitis diagnosis confirmed by a clinician
- •Clinically stable condition at enrollment
- •Written informed consent obtained from parents or legal guardians
排除标准
- •Congenital skin anomalies
- •Dermatitis due to other dermatological conditions
- •Systemic bacterial or fungal infections
- •Receiving immunosuppressive treatment
研究组 & 干预措施
Hydrocolloid dressing
干预措施: Hydrocolloid dressing (Device)
Zinc oxide cream (Control group)
干预措施: Zinc oxide cream %40 (Drug)
结局指标
主要结局
Change in diaper dermatitis severity score
时间窗: Baseline, 24 hours, 48 hours, and 72 hours after initiation of intervention.
The severity of diaper dermatitis will be assessed using the Clinical Evaluation Scale for Characterization of the Severity of Diaper Dermatitis (Stamatas \& Tierney, 2014). Scores range from 0 (no dermatitis) to 3.0 (severe dermatitis), with 0.5-point increments. Higher scores indicate greater severity.
Time to complete healing of diaper dermatitis
时间窗: Within 72 hours after initiation of intervention.
Complete healing is defined as a diaper dermatitis score of "0" on the Clinical Evaluation Scale. The proportion of infants achieving complete healing within 72 hours will be compared between groups.
次要结局
未报告次要终点
研究者
Gozde AKSUCU
Assistant Professor (PhD)
University of Beykent