Early Supplementation of Melatonin in Preterm Newborns: the Effects on Oxidative Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measurement of the melatonin concentration
研究概览
简要总结
Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals. In preterm neonates, melatonin deficiency has been reported. Several studies tested the efficacy of melatonin to counteract oxidative damage in diseases of newborns such as chronic lung disease, perinatal brain injury, necrotizing enterocolitis, retinopathy of prematurity and sepsis, giving promising results. In these studies, the dosages of melatonin varied over a wide range. The present study was designed to test the hypothesis that oral administration of melatonin reduced OS and consequentially, the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) in preterm newborns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Hour 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <37 weeks
- •Normal liver function tests
- •Normal kidney function tests
排除标准
- •All babies not born in the clinic
- •All babies with severe congenital malformations
- •Inborn errors of metabolism
- •Babies suffering from perinatal asphyxia
- •Babies born from mothers with mental disorders
- •Sample hemolysis
- •Insufficient sample
- •withdraw informed consent.
研究组 & 干预措施
Control Group
干预措施: Placebo (Other)
Melatonin Group
干预措施: Melatonin drops (Dietary Supplement)
结局指标
主要结局
Measurement of the melatonin concentration
时间窗: All participants will be evaluated at 48 hours of life
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
Measurement of the melatonin concentration
时间窗: All participants will be evaluated at 24 hours of life
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
次要结局
- Measurement of AOPP(All participants will be evaluated at 48 hours of life)
- Measurement of NPBI(All participants will be evaluated at 48 hours of life)
- Measurement of isoprostanes(All participants will be evaluated at 48 hours of life)
- Measurement of AOPP(All participants will be evaluated at 24 hours of life)
- Measurement of NPBI(All participants will be evaluated at 24 hours of life)
- Measurement of isoprostanes(All participants will be evaluated at 24 hours of life)