Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- patient characteristics all cause mortality
研究概览
简要总结
The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants thought/diagnosed to have late or early onset sepsis.
排除标准
- •Pentoxifylline or Pentaglobin has already been given
- •Pentoxifylline or Pentaglobin is thought to be needed or contra-indicated
- •Major congenital anomaly
- •Intraventricular hemorrhage (Grade 3 veya 4)
- •Congenital infections
- •Inborn errors of metabolism
研究组 & 干预措施
Placebo group
Receiving standard treatment plus placebo (5 mls/Kg of normal saline intravenously given over 4 hours).
干预措施: Pentoxifylline, pentaglobin (Drug)
Pentoxifylline group
Standard treatment plus 6 mg/Kg of Pentoxifylline intravenously (given over 4 hours) daily for three days.
干预措施: Pentoxifylline, pentaglobin (Drug)
Pentaglobin group
Standard treatment plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days
干预措施: Pentoxifylline, pentaglobin (Drug)
Pentoxifylline plus Pentaglobin group
Standard treatment plus 6 mg/Kg of Pentoxifylline plus 250 mg/Kg of Pentaglobin intravenously (given over 4 hours) daily for three days.
干预措施: Pentoxifylline, pentaglobin (Drug)
结局指标
主要结局
patient characteristics all cause mortality
时间窗: two years
Does adjuvant Pentoxifylline or Pentoxifylline plus IgM-enriched IVIG reduce mortality from Neonatal sepsis
次要结局
- Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels(two years)
- Effect the production of pro-inflammatory bio-markers.(two years)