Effect of Topical Oil Application on Trans-epidermal Water Loss (TEWL) in Preterm Very Low Birth Weight (VLBW) Infants - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Trans Epidermal Water Loss(TEWL)
研究概览
简要总结
The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Oil application on the skin can act as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut oil, often used for traditional massage of babies by Indian communities, is culturally acceptable and Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Hours 至 168 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All preterm babies born at the study center with birth weight < 1500gms were eligible for inclusion in the study.
排除标准
- •Babies with birth weight less than 750 gms at birth
- •Babies with major congenital malformations.
- •Babies with severe asphyxia, hydrops and shock.
- •Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
- •Babies with preexisting skin infection such as multiple furuncles (2 or more skin areas - each limb, head, chest, abdomen and back are the individual areas that will be taken as one area
结局指标
主要结局
Trans Epidermal Water Loss(TEWL)
时间窗: first 7 days of life
TEWL was measured using evaporimeter(Vapometer, Delfin Technologies limited, Kuopio, Finland) at 12 hours of age and thereafter every 12 hours during the first week of life (168 hrs of life)
次要结局
- Weight(Weight first 7 days of life and 40 weeks postmenstrual age)
- Skin condition Score(Skin condition Score at day 7 of life)
- Skin colonization pattern(Skin colonization pattern at day 7 of life)