Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 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. Edible coconut oil application on the skin acts as a non permeable barrier and can help in achieving this. 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
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Hours 至 7 Days（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 < 1500g 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)
研究组 & 干预措施
Coconut Oil Application
The oil (coconut oil) was applied by the trained nurse to the entire body surface of infant except the face two times a day started as early as possible Four ml of coconut oil was applied using both hands of the caregiver in four strokes starting from the level of clavicles over the chest and abdomen till the groin, from the front of thighs, knee, leg and upto the sole, from above the shoulders over the arm and forearm till the palm continuing medially over the forearm and arm till the axilla and the final stroke was used for the back reaching over the back of the thighs till the heel. Just prior to the first application, and thereafter prior to the subsequent applications the TEWL was recorded using the portable closed chamber evaporimeter. The oil application was continued twice daily (every 12 hrs at the same time as the hour of birth e.g. 11 am and 11pm) till the completion of the seventh day (168 hrs of life)..
干预措施: Coconut Oil Application (Procedure)
No Oil Application
Babies in this group were not subjected to oil application. TEWL measurement was recorded every 12 hrs for the first week of life, at the same time as the hour of birth.
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 till first 7 days of life
次要结局
- Skin colonization pattern(at day 7 of life)
- Weight(first 7 days of life and 40 weeks postmenstrual age)
- Skin condition Score(at day 7 of life)
研究者
Sushma Nangia, M.D.
Professor
Lady Hardinge Medical College