The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- The Number of Days Free From Diaper Dermatitis
研究概览
简要总结
The purpose of the study is to examine the safety and effectiveness of the use of coconut oil for the prevention and treatment of diaper dermatitis among NICU babies at Genesis Medical Center, Davenport.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Hours 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Babies admitted to the Genesis NICU
- •Anticipated stay in the NICU is ≥ 48 hours
- •Babies wearing diapers 24 hours a day
- •Parent willing to sign informed consent for the study
- •Parent willing to use the test products in the diaper area during the trial
- •Parent willing to not change the type or brand of diaper and wipes during the study
- •Parent willing to refrain from changing any other products whose use may have an effect of their baby's skin condition during the trial
排除标准
- •Babies with a gestational age <30 weeks
- •Babies with major congenital malformations
- •Active dermatological conditions other than diaper dermatitis that may affect trial results
- •Known sensitivity to ingredients in trial products
- •Babies whose parents have a hazelnut or coconut allergy
- •Other severe acute medical conditions that may increase the risk associated with trial participation
研究组 & 干预措施
Coconut Oil
Participants in this group will receive a generous layer of organic, unrefined coconut oil applied to the diaper area (buttocks and creases between thighs and hips) at each diaper change. This will continue until the patient is discharged or reaches the primary safety endpoint (skin that is eroded and/or blistered in the diaper area with bleeding).
干预措施: Organic, Unrefined Coconut Oil (Other)
Standard of Care
Participants in this group will receive the standard of care for preventing and treating diaper dermatitis at Genesis. This includes no treatment until a diaper dermatitis appears. If diaper dermatitis appears, participants will receive a generous layer of Medline Remedy Phytoplex Z-Guard Skin Protectant applied to the diaper area (buttocks and creases between thighs and hips) at each diaper change. This will continue until the patient is discharged or reaches the primary safety endpoint (skin that is eroded and/or blistered in the diaper area with bleeding).
干预措施: Medline Remedy Phytoplex Z-Guard Skin Protectant (Other)
结局指标
主要结局
The Number of Days Free From Diaper Dermatitis
时间窗: Once, at hospital discharge, an average of 2 weeks
The number of days free from diaper dermatitis.
The Number of Patients Experiencing Adverse Events
时间窗: Once, at hospital discharge, an average of 2 weeks
The number of patients experiencing adverse events.
次要结局
- The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used(Once, at study completion for hospital discharge, an average of 2 weeks)