Development, implementation, and evaluation of a Neonatal Infection Reduction Bundle for sustained reduction in late-onset sepsis in the Neonatal Intensive Care Unit of a tertiary care hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,347
- 试验地点
- 1
- 主要终点
- Rates of the Late onset neonatal sepsis episodes(culture proven or probable sepsis treated with seven days of antibiotics) that occurs after 72 hours of birth
研究概览
简要总结
Neonatal infection in a neonatal intensive care unit is a major challenge for the healthcare professionals, as infections are the leading cause of neonatal morbidity and mortality, apart from prematurity.
The hypothesis of the study is that a customized neonatal infection reduction bundle can reduce late-onset neonatal sepsis in a sustained manner amongst neonates admitted to the NICU.
The study is designed to develop a neonatal infection reduction care bundle based on the analysis of the observational period and systematic review of the interventional studies done for late-onset neonatal sepsis reduction in neonates admitted to the neonatal intensive care unit. Also, a qualitative study will be conducted to look into the factors influencing the sustainability of infection reduction practices among the healthcare providers working in the neonatal intensive care unit. These factors will be looked into while devising the care bundle and addressed during the implementation of the neonatal infection reduction bundle in the unit. The neonatal infection reduction care bundle devised will be implemented over a period of three months and there after continued in the unit. During this phase multiple iterative steps will be taken to ensure compliance to the bundle, using the Plan-Do-Study-Act cycles.The impact of the bundle will be assessed by the reduction in the late-onset sepsis rates using the interrupted time series chart(post interventional phase).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All neonates admitted in the neonatal intensive care unit(level2 and 3).
排除标准
- •Suspected or proven neonatal sepsis at time of admission Infection within 48 hours of life.
结局指标
主要结局
Rates of the Late onset neonatal sepsis episodes(culture proven or probable sepsis treated with seven days of antibiotics) that occurs after 72 hours of birth
时间窗: at 7 days of admission to neonatal intensive care unit
次要结局
- Factors influencing sustainability of the infection reduction practices by the care providers(7days of admission of newborn to the unit)
研究者
Dr Suprabha K Patnaik
Bharati Vidyapeeth deemed to be university Medical college