Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- good short term out come
研究概览
简要总结
Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.
详细描述
Magnesium sulphate has a neuroprotective potential as has been shown by many studied in pregnant ladies with eclampsia where it helped neonates also and in mothers with preterm labour where the incidence of cerebral palsy was less. We designed a randomised controlled trial on 40 neonates with severe perinatal asphyxia to see whether it helps in the short term outcome of these neonates.
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
- •Babies eligible for the study were:
- •Term or post term
- •Less than 6 hours of age and had
- •severe perinatal asphyxia as manifested by any three of the following criteria.
- •History of fetal distress (late deceleration, Loss of beat to beat variability, fetal bradycardia, meconium stained amniotic fluid)
- •Need for immediate neonatal ventilation with bag and mask or through endotracheal intubation for 2 minutes or more after delivery
- •A 5-minute Apgar score of < 6
- •Base deficit 15 mEq/L in cord blood or admission arterial or cord blood pH 4.Moderate to severe encephalopathy
排除标准
- •Patients with severe IUGR
- •Any condition unrelated to asphyxia
- •Maternal prenatal magnesium administration
- •Metabolic disorder
- •Chromosomal anomalies; and
- •Congenital malformations were excluded from the study
研究组 & 干预措施
Magnesium sulphate, neurological outcome
Magnesium sulphate 250mg/kg after every 24 hours starting within 6 hours from birth
干预措施: Magnesium sulphate (Drug)
Placebo
Placebo every 24 hours for 3 doses starting from 6 hours after birth
干预措施: Normal saline (Drug)
结局指标
主要结局
good short term out come
时间窗: at discharge
Death and or abnormal neurological outcome at discharge
次要结局
- abnormal neurological examination and abnormal CT Head(at discharge)
研究者
Dr.Mushtaq
Professsor
Sheri Kashmir Institute of Medical Sciences