Use of Magnesium Sulphate in Neonatal Asphyxia and Its Effect on Duration of Hospital Stay
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Duration of Hospital Stay
研究概览
简要总结
Neonatal asphyxia causes significant global morbidity, frequently resulting in Hypoxic-Ischemic Encephalopathy (HIE). In resource-limited settings where therapeutic hypothermia is unavailable, affordable neuroprotective options are needed. Intravenous magnesium sulphate blocks NMDA receptors, limiting cellular calcium influx and neuroinflammation. This randomized controlled trial evaluates whether adjuvant intravenous magnesium sulphate (250\text{ mg/kg} within 6 hours of birth) reduces the duration of hospital stay and improves short-term clinical outcomes in term neonates with birth asphyxia.
详细描述
Perinatal asphyxia triggers secondary brain injury through glutamate release, NMDA receptor overactivation, and intracellular calcium accumulation, leading to Hypoxic-Ischemic Encephalopathy (HIE). Magnesium sulphate acts as a neuroprotective agent by blocking NMDA-gated channels, stabilizing cell membranes, and reducing cerebral edema.
This prospective, randomized trial evaluates 72 term neonates (\ge 37 weeks) admitted with birth asphyxia within 24 hours of birth. Participants are allocated into two equal groups (n = 36 each):
Intervention Group: Receives standard NICU care plus IV Magnesium Sulphate (250\text{ mg/kg} over 30\text{--}60 minutes) within 6 hours of life.
Control Group: Receives standard NICU supportive care alone.
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
- None
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term neonates (gestational age more than 37 weeks),
- •age less than 24 hours,
- •diagnosed with birth asphyxia (Apgar score less than 5 at 5 minutes or 4)Evidence of hypoxic-ischemic injury within 6 hours of birth).
排除标准
- •Major congenital anomalies
- •neonatal sepsis at admission,
- •preterm neonates (<37 weeks),
- •metabolic disorders.
研究组 & 干预措施
Control group
Term neonates with birth asphyxia who receive standard NICU supportive management alone
干预措施: Supportive care and standard neonatal intensive care unit care (Other)
Magnesium sulphate group
Intravenous infusion of Magnesium Sulphate at a dose of 250\text{ mg/kg} administered over 30\text{--}60 minutes within 6 hours of birth
干预措施: Magnesium sulphate (Drug)
结局指标
主要结局
Duration of Hospital Stay
时间窗: Up to 6 months
Total length of time the neonate requires inpatient care, measured as the number of days from admission to the Neonatal Intensive Care Unit (NICU) until formal hospital discharge.
次要结局
- Neonatal Mortality Rate(up to 6 months)
- Seizure Status at Discharge(Up to 6 months)
- Time to Establish Oral Feeding(up to 6 months)
- Neurological Examination at Discharge(With in 1 week)