Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- death up to discharge of hospital
研究概览
简要总结
Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or inflammatory cerebral lesions. It is associated with a significant reduction of perinatal death and cerebral palsy in some observational studies.
The objective of the study is to assess if prenatal magnesium sulfate given to women at risk of preterm birth before 33 week's gestation is neuroprotective.
详细描述
This is a randomized controlled trial at 18 french tertiary hospitals with stratification by center and multiple births in women at risk of preterm birth before 33 week's gestation and without vascular disease of pregnancy.
Women received 4 g of a 0.1 g/ml magnesium sulfate solution or isotonic serum chloride solution (0.9%).
The main outcome measures are rates of mortality up to discharge, of severe white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages on cranial ultrasonographic studies) and of combined death and severe white matter injury.
The secondary outcome measures are rates of white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages and persisting hypechogenicities at 15 day intervals on cranial ultrasonographic studies), follow-up at two years of age
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
- Single
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •women pregnant with single, twin or triplet very preterm fetuses younger than 33 week's gestational age if birth was expected or planned within 24 hours
排除标准
- •women with vascular disease of pregnancy
- •women with severe malformation or chromosomal abnormalities in the fetus
- •women with hypotension
- •renal insufficiency
- •cardiac rhythmic abnormalities
- •intake of calcium channel inhibitors
- •digitalis or indomethacin less than 24 hours
- •persistence of signs of cardiovascular toxicity or tachycardia for more than one hour after cessation of betamimetic intake
- •myasthenia
- •emergency C section
结局指标
主要结局
death up to discharge of hospital
severe white matter injury
combined death up to discharge and severe white matter injury
次要结局
- white matter injury
- topography of cysts
- follow-up at two years of age
- cystic periventricular leukomalacia
- intraventricular/intraparenchymal haemorrhages
- side effects of magnesium sulfate in mothers and preterm newborns