Effects of Melatonin as a Novel Antioxidant and Free Radicals Scavenger in Neonatal Sepsis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 主要终点
- Melatonin as an antioxidant and free radicals scavenger in Neonatal sepsis
研究概览
简要总结
Assess the efficacy of melatonin as an adjuvant in the treatment of free radical disease in septic preterms receiving melatonin compared to those on conventional treatment through measuring the level of Malondialdehyde as a marker of oxidative stress and by comparing other clinical and laboratory parameters of sepsis in both groups.
详细描述
This is a randomized controlled trial. It will be provisionally conducted on 55 neonates admitted to the neonatal intensive care units (NICUs) of Ain Shams University Hospitals, Cairo, Egypt.
Inclusion criteria:
The study will include:Preterm infants (less than 37 weeks gestational age). Evidence of neonatal sepsis.
Exclusion Criteria: Neonate with evidence of any of the following will be excluded:
Infants with hypoxic ischemic encephalopathy. Infants on nothing per os. Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Preterm infants ( less than 37 weeks gestational age). Evidence of neonatal sepsis
排除标准
- •Infants with hypoxic ischemic encephalopath Infants on nothing per os. Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.
研究组 & 干预措施
Sepsis A Group
neonates diagnosed with Sepsis and will receive melatonin. 10 mg product as a total dose of 20 mg .together with conventional treatment of Neonatal sepsis
干预措施: Melatonin 10 mg (Drug)
Sepsis A Group
neonates diagnosed with Sepsis and will receive melatonin. 10 mg product as a total dose of 20 mg .together with conventional treatment of Neonatal sepsis
干预措施: Conventional treatment of neonatal sepsis (Combination Product)
Sepsis B Group
neonates diagnosed with Sepsis and willnot receive melatonin., they will recieve only the conventional treatment of Neonatal Sepsis
干预措施: Conventional treatment of neonatal sepsis (Combination Product)
结局指标
主要结局
Melatonin as an antioxidant and free radicals scavenger in Neonatal sepsis
时间窗: 3 days
efficacy of melatonin as an adjuvant in the treatment of free radical disease in septic preterms receiving melatonin compared to those on conventional treatment through measuring the level of Malondialdehyde as a marker of oxidative stress
次要结局
- melatonin as an adjuvant in management of neonatal sepsis(3 days)
研究者
Mohamed Hussein Metwally
Assistant Lecturer
Ain Shams University