跳至主要内容
临床试验/NCT00434408
NCT00434408已完成3 期

Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 28,797 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
28,797
试验地点
1
主要终点
omphalitis among live born infants.

研究概览

简要总结

A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution

详细描述

Of the annual four million neonatal deaths, 99% occur in developing countries, and more than one-third globally can be attributed to infections. In areas with high-mortality rates, the proportion attributable to infections is as high as 50%. Many infections in infants can be prevented or treated with already existing measures, yet finding the best way to provide these measures in communities that are limited in resources need to be identified. Applying chlorhexidine to the umbilical cord of newborns may be a simple way to help reduce neonatal mortality and morbidity in the community at low cost.

A study by our group was recently completed in Nepal. It was a large community-based, factorial-designed trial in southern Nepal to: (1) assess the impact of newborn total body skin cleansing with 0.25% chlorhexidine on neonatal mortality and morbidity and (2) assess the impact of cleansing of the umbilical stump with 4% chlorhexidine on omphalitis and neonatal mortality.

The results of these studies have suggested that chlorhexidine antisepsis interventions may significantly reduce neonatal mortality and omphalitis. A single full body cleansing of the neonate with chlorhexidine as soon as possible after birth reduced mortality among low birth weight (LBW) infants by 28%. Repeated cleansing of the umbilical stump with chlorhexidine reduced the rate of severe cord infection by 75% and, if this treatment was begun within the first 24 hours following birth, reduced neonatal mortality by 34%.

In rural Bangladesh, over 90% of women deliver at home with only untrained local women or family members in attendance, and low birth weight babies are delivered approximately 30% of the time. The overall neonatal mortality rate exceeds 36 per 1000 live births and in order to reduce this burden, simple, cost-effective interventions that can be delivered at the community level are urgently needed. Given the potential impact of repeated chlorhexidine cleansing of the cord demonstrated in the Nepal trial, a replication study of this regimen and further investigations of more simple regimens are necessary. The number of treatments necessary to reduce neonatal mortality has important programmatic implications for who can deliver the intervention, and how it is packaged.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Minute 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • live-born infants delivered in one of three upazillas of Sylhet District (Zakiganj, Khanaighat, Beanibazar)
  • married women of reproductive age within their individual target areas listed above

排除标准

  • individuals outside of the target area in Sylhet(Zakiganj, Khanaighat, Beanibazar)
  • infants not met at home by a project worker during the first seven days of life

结局指标

主要结局

omphalitis among live born infants.

时间窗: 3 Month intervals

neonatal mortality

时间窗: 3 Month intervals

次要结局

  • newborn care practices(3 Years)
  • care seeking behaviors(3 Years)
  • morbidity measures, including sepsis and omphalitis(3 Years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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