Role of Lactoferrin 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
- 50
- 试验地点
- 1
- 主要终点
- Prevention of VAP
研究概览
简要总结
The aim of the study is to
- Evaluate the preventive value of Lactoferrin on VAP among ventilated neonates.
- Evaluate the Primary outcome of Lactoferrin on:
Sepsis, Feeding intolerance, Vomiting, Constipation or diarrhea 3. Evaluate the effect of Lactoferrin in critically ventilated neonates on:
Incidence of VAP Duration of mechanical ventilation Duration of hospital stay
详细描述
Randomised controlled trial
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
- 0 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates requiring mechanical ventilation.
- •Gestational age: (GA 28-36 weeks).
- •Expected need for mechanical ventilation for ≥ (48hours)
排除标准
- •Congenital anomalies of the lung or airway.
- •Major congenital heart disease.
- •Proven early-onset sepsis at enrollment.
- •Severe perinatal asphyxia (e.g., Apgar < 3 at 5 minutes or seizures).
- •Known contraindication or allergy to lactoferrin.
- •Severe gastrointestinal pathology (e.g., NEC stage II or higher).
- •Any condition deemed by the clinical team to interfere with study participation.
研究组 & 干预措施
Lactoferrin group
Neonates who will receive oral lactoferrin supplementation.
干预措施: Lactoferrin in prevention of VAP (Dietary Supplement)
Control
who Will not receive
干预措施: Control (Other)
结局指标
主要结局
Prevention of VAP
时间窗: during NICU stay
Incidence of ventilator-associated pneumonia during mechanical ventilation.
Prevention of VAP
时间窗: From enrollment until day 28 of life or NICU discharge, whichever occurs first.
Diagnosis of VAP using the CDC/NHSN clinical and radiological criteria for neonatal ventilator-associated events. Outcome measured as the percentage (%) of enrolled neonates who develop VAP during NICU stay or up to 28 days of life.
次要结局
未报告次要终点
研究者
Dalia Mohamed Salah
Lecturer
Tanta University