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临床试验/NCT01758068
NCT01758068已完成不适用

Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail

Lady Hardinge Medical College0 个研究点目标入组 74 人开始时间: 2005年11月最近更新:
适应症

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

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)

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

  • Weight(first 7 days of life and 40 weeks postmenstrual age)
  • Skin condition Score(at day 7 of life)
  • Skin colonization pattern(at day 7 of life)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sushma Nangia, M.D.

Professor

Lady Hardinge Medical College

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