NCT02002039已完成2 期
Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial
Sheri Kashmir Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Death or moderate or severe disability at 18-22 months of age
研究概览
简要总结
Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.
详细描述
will be a randomized trial
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Babies with severe perinatal asphyxia with moderate to severe HIE in the immediate neonatal period
排除标准
- •Babies with congenital malformations
- •Small for gestational age babies
- •Babies with chromosomal anomalies
研究组 & 干预措施
erythropoietin, perinatal asphyxia,
Active Comparator
Treatment group
干预措施: Erythropoietin (Drug)
Normal saline, perinatal asphyxia
Placebo Comparator
Normal saline on alternate days for 5 doses starting from first 6 hours of life
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Death or moderate or severe disability at 18-22 months of age
时间窗: 18-22 months
次要结局
- Bayley psychomotor development index(18-22 months months)
- Hearing loss at 18-22 months(18-22 months)
- Disability(18-22 months)
研究者
Dr.Mushtaq
Professor
Sheri Kashmir Institute of Medical Sciences
研究点 (1)
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