Prevention of Nosocomial Bacteremia and Mortality Among Neonates at a Tertiary Referral Center in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,410
- 试验地点
- 1
- 主要终点
- All-cause neonatal mortality in hospitalized neonates
研究概览
简要总结
The purpose of this study is to estimate the burden of disease, identify risk factors associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the investigators propose to study the impact of a novel package of infection control interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center in sub-Saharan Africa.
详细描述
The study is an18 month prospective quasi-experimental evaluation of nosocomial bacteremia and mortality among hospitalized neonates and will consist of a 6-month baseline period to capture the incidence and all-cause mortality of nosocomial BSIs, a 1-month implementation period of low-cost infection control strategies (including alcohol-based hand rub [AHR], 2% chlorhexidine gluconate [CHG], hospital staff education and text message-based reminders of infection control recommendation) and an 11-month intervention period.
All neonates admitted to the neonatal intensive care unit (NICU) of the University Teaching Hospital (UTH) in Lusaka, Zambia during the study period will be eligible for study enrollment. This study will determine the capacity of an innovative bundle of low cost, simple and locally available interventions that leverage new technologies and expand application of highly effective interventions in order to reduce the incidence of nosocomial bacteremia among NICU patients in a developing country setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates admitted to the study site NICU during the study period (including both "inborn" and "outborn" neonates)
排除标准
- •Neonates without documented birth date
- •Parent or guardian unavailable or unwilling to provide consent
研究组 & 干预措施
Intervention
Infection control package consisting of alcohol hand rub hand hygiene (HH), 2% chlorhexidine gluconate (CHG) body washes, infection control training, and text messages with basic Infection control reminders via SMS text
干预措施: Chlorhexidine gluconate (CHG) (Drug)
Intervention
Infection control package consisting of alcohol hand rub hand hygiene (HH), 2% chlorhexidine gluconate (CHG) body washes, infection control training, and text messages with basic Infection control reminders via SMS text
干预措施: Hand hygiene (HH) (Behavioral)
Intervention
Infection control package consisting of alcohol hand rub hand hygiene (HH), 2% chlorhexidine gluconate (CHG) body washes, infection control training, and text messages with basic Infection control reminders via SMS text
干预措施: Infection control training (Behavioral)
Intervention
Infection control package consisting of alcohol hand rub hand hygiene (HH), 2% chlorhexidine gluconate (CHG) body washes, infection control training, and text messages with basic Infection control reminders via SMS text
干预措施: Infection control reminders via SMS text (Other)
结局指标
主要结局
All-cause neonatal mortality in hospitalized neonates
时间窗: 18 months
in hospitalized neonates at University Teaching Hospital (UTH), a large tertiary referral center, in Zambia before and after the introduction of low-cost infection-control interventions.
次要结局
- Prevalence of nosocomial bacteremia caused by MDR-GNR infections among hospitalized neonates(18 months)
- Incidence of nosocomial bacteremia in hospitalized neonates(18 months)
- Attributable risk of maternal, neonatal, hospital factors and nosocomial bacteremia among hospitalized neonates(18 months)