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临床试验/NCT00198627
NCT00198627已完成不适用

Etiology, Prevention, and Treatment of Neonatal Infections in the Community

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 16,359 人开始时间: 2003年12月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
16,359
试验地点
1
主要终点
Health workers will visit households at three month intervals for 18 months and survey the status of the babies.

研究概览

简要总结

The purpose of this study is to determine what are the major types of bacteria that cause newborn infections in the community in rural Bangladesh and whether providing an obstetric and neonatal care package will reduce neonatal deaths by 40%.

详细描述

The study seeks answers to two questions:

  1. What are the major bacterial pathogens responsible for serious neonatal infections in the community in rural Bangladesh?
  2. Can provision of a package of obstetric and neonatal care, including active surveillance for serious neonatal illness and referral to hospital, and identification of barriers to care-seeking and design of strategies to address them reduce neonatal mortality rates by at least 40% compared to communities in which such services are not provided?

Despite significant decline in infant and child mortality rates in recent decades, neonatal mortality rates remain unacceptably high. Of the 8 million infant deaths that occur worldwide each year, approximately 4 million occur in the neonatal period.

Hence, the specific aims of the study include:

  1. identifying the principal agents of serious bacterial infections in Bangladeshi neonates in the community
  2. evaluating the impact of introducing a package of essential obstetric and neonatal care practices in the community, including identifying barriers to care-seeking and design of strategies to address those barriers and
  3. building capacity within Bangladesh by training Bangladeshi scientists in epidemiological and microbiological techniques, clinical research methods and best clinical practice through an on-going collaboration with Dhaka Shishu (Children) Hospital and the International Centre for Diarrhoeal Disease Research, Bangladesh.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pregnant women (any age)

排除标准

  • children (outside newborn period)

结局指标

主要结局

Health workers will visit households at three month intervals for 18 months and survey the status of the babies.

次要结局

  • At anytime during the study, if the baby shows symptoms of serious infection, the health worker will offer advice on where to go for treatment, or offer to treat the baby at home.

研究者

研究点 (1)

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