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临床试验/NCT01177111
NCT01177111已完成3 期

Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 29,260 人开始时间: 2010年11月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
29,260
试验地点
1
主要终点
all cause neonatal mortality

研究概览

简要总结

Each year four million babies die during the neonatal period, with the majority occurring in developing countries. Overall, infections account for one-third of all neonatal deaths, with proportions approaching 50% in settings where neonatal mortality rates are high. Infections are predominately due to sepsis, respiratory infections, tetanus, and diarrhea. The investigators long term goal is to identify simple, affordable, and effective interventions that can be delivered at the community level in low-resource settings to reduce neonatal mortality risk due to these infections. The investigators team has conducted research in this area for the past 10 years, with specific focus on newborn vitamin A dosing and topical chlorhexidine antisepsis interventions. Previous community-based research by the investigators group of investigators and others demonstrated that newborn vitamin A dosing can reduce early infant mortality by approximately 20%, and that topical applications of chlorhexidine to the umbilical cord can prevent omphalitis and reduce neonatal mortality risk by 24%. Evidence is growing that neonatal skin plays an important role in protecting the newborn infant from invasive pathogens. Barrier function of the neonatal skin, however, is incomplete in newborn infants, especially those that are pre-term or of low birth weight. Full-body massage of newborns with mustard oil, practiced almost universally (~95%) in communities of south Asia, may further compromise skin barrier function through decreased structural integrity leading to increased trans-epidermal water loss and increased risk of percutaneous penetration by invasive pathogens. Loss of structural integrity is not seen after massage of neonatal skin with alternative topical emollients, including sunflower seed oil. Furthermore, sunflower seed oil has been shown to accelerate recovery of the skin barrier function, improve skin condition, and reduce the risk of both nosocomial infections and neonatal mortality among hospitalized newborns in low-resource settings. The specific hypothesis of this study is that substituting mustard oil with sunflower seed oil for topical applications during full body massage of newborns in the community will reduce neonatal mortality and morbidity by improving overall skin barrier function and reducing exposure to invasive pathogens.

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
— 至 28 Days(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Baby born alive
  • •Baby born in study area

排除标准

  • 未提供

研究组 & 干预措施

Mustard seed oil

Active Comparator

干预措施: Mustard seed oil (Other)

Sunflower seed Oil

Experimental

干预措施: Sunflower seed oil (Other)

结局指标

主要结局

all cause neonatal mortality

时间窗: first 28 days after birth

A neonatal death is defined as death of a live born baby before completion of reaching 28.0 days old.

neonatal morbidity

时间窗: first 28 days after birth

Probable severe disease in newborns will be defined using the current World Health Organization (WHO) Young Infant Study Algorithm and appropriate adaptations

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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