Assessment of the Role of Probiotics in Prevention of Ventilator-Associated Pneumonia in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- VAP incidence rate
研究概览
简要总结
Evaluate the preventive value of probiotics on VAP among ventilated neonates.
详细描述
MV is a critical component of neonatal intensive care, providing essential respiratory support for neonates with severe respiratory distress. However, its use is associated with an increased risk of VAP, a serious nosocomial lung infection. VAP is defined as a pneumonia diagnosed in patients undergoing MV for at least 48 hours and is recognized as the second most common nosocomial infection in neonatal and pediatric intensive care units. Its incidence ranges from 1 to 63 episodes per 1,000 ventilation days, with variability influenced by the socioeconomic and healthcare development of different regions.Given the complex pathophysiology of VAP, numerous prevention strategies have been proposed for NICUs.Among these strategies, probiotics have emerged.
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
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All term neonates who required mechanical ventilation with ETT for more than 48 hours.
排除标准
- •Early-onset neonatal sepsis
- •Pre-existing pneumonia
- •A patient who was unfit for enteral intake.
- •Prematurity <37 gestational weeks.
- •Surgical causes of mechanical ventilation
- •Multiple congenital anomalies and suspected chromosomal anomalies.
研究组 & 干预措施
Non-probiotic group
40 ventilated neonates who only received the standard of care treatment
Probiotic group
40 ventilated neonates who received commercially available probiotics
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
VAP incidence rate
时间窗: one year
Evaluation of the role of probiotics in the Prevention of neonatal VAP and examining their impact on the incidence of VAP at those neonates.
次要结局
- GIT manifestations(one year)
- Duration of MV and NICU stay(one year)
研究者
Lamiaa Khaled Zidan
Lecturer
Tanta University