Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality: A Cluster Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,600
- 试验地点
- 24
- 主要终点
- Incidence of hospital-acquired infection
研究概览
简要总结
This 4-year cluster randomized controlled trial aims to determine whether implementation of Evidence-based Practice for Improving Quality (EPIQ) method can reduce hospital-acquired infection in Chinese Neonatal Intensive Care Units (NICUs).
详细描述
Following randomization into two groups, the intervention NICUs (n = 12) will receive training in the EPIQ method and then develop, implement, and document evidence-based practice changes to reduce hospital-acquired infection. Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support. Control NICUs (n = 12) will collect neonatal data and continue to provide standard care. Study subjects will be all preterm infants born at <34 weeks' gestation and admitted to participating NICUs during the trial (estimated n = 5,200 per year). Data analysis will be conducted to compare neonatal outcomes and health-care resources used between the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at <34 weeks' gestation
- •Admitted to the participating NICUs within 7 days after birth
- •Admitted to the participating NICUs between May 1, 2015 and April 30, 2018
排除标准
- •Infants with major congenital anomalies
- •Infants who are moribund on admission (a decision is made to provide only palliative care)
研究组 & 干预措施
Control sites
Continue current practices
EPIQ sites
Use Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection
干预措施: Evidence-based Practice for Improving Quality (EPIQ) method (Behavioral)
结局指标
主要结局
Incidence of hospital-acquired infection
时间窗: Three years
Combined cases of following types of hospital-acquired infection: ventilation associated pneumonia, central line-associated blood stream infection (CLABSI), blood stream infections excluding CLABSI, urinary tract infections, meningitis, clinical sepsis
次要结局
- Incidence of ventilation associated pneumonia(Three years)
- Days on antibiotics(Three years)
- Incidence of meningitis(Three years)
- Incidence of central line-associated blood stream infection(Three years)
- Days on total parenteral nutrition(Three years)
- Incidence of blood stream infection excluding CLABSI(Three years)
- Incidence of clinical sepsis(Three years)
- Incidence of urinary tract infections(Three years)
- Incidence of stage ≥2 necrotizing enterocolitis(Three years)
- Days on ventilation support(Three years)
- Days on inotropes(Three years)
- All cause mortality(Three years)
- Infection-related mortality(Three years)