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临床试验/NCT00109616
NCT00109616已完成3 期

Newborn Antiseptic Washing and Neonatal Mortality-Nepal

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)3 个研究点 分布在 2 个国家目标入组 17,000 人开始时间: 2002年10月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
17,000
试验地点
3
主要终点
neonatal mortality

研究概览

简要总结

Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver babies at home without a skilled birth attendant.

The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and water or an antiseptic solution for the first few days of life can reduce umbilical cord infections.

详细描述

While significant progress has been made in reducing preschool child mortality in developing countries over the past 20 years, much less progress has been made in reducing neonatal mortality and morbidity. Neonatal mortality rates are high in Nepal; a significant proportion of which are due to sepsis. In addition, the vast majority of women deliver babies at home without a skilled birth attendant and early neonatal care is routinely used in rural areas. Previous hospital-based research in Malawi suggested that newborn cleansing with a dilute chlorhexidine solution could reduce early infant mortality. This project evaluates the use of a simple intervention at the community level and the impact on neonatal mortality.

Comparisons: Two nested community-based randomized trials are being conducted. The first compares the neonatal mortality rates between newborn infants randomized to receive a whole body skin cleansing soon after birth with baby wipes impregnated with 0.25% chlorhexidine compared with newborns cleaned with baby wipes with a placebo solution. The second trial compares the rates of umbilical cord infections among children assigned to three groups:

  • education of the mother on clean cord care alone;
  • education of the mother plus routine washing of the cord and stump with soap and water solution for the first 10 days of life; -OR-
  • education of the mother plus routine washing of the cord and stump with a 4% chlorhexidine solution.

Enrolled infants are visited on a regular basis during the first month of life to record vital status and grade the cord for signs of infection.

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
Double

入排标准

年龄范围
1 Minute 至 10 Days(Child)
性别
All
接受健康志愿者

入选标准

  • All liveborn infants born in the study area

排除标准

  • Newborn infants who died prior to study staff arriving to conduct the interventions

结局指标

主要结局

neonatal mortality

umbilical cord infection

次要结局

未报告次要终点

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (3)

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