Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- DDST-II
研究概览
简要总结
Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting the human brain has not been studied. We aimed in this study to test the hypothesis that a combination of anti-oxidants (vitamin C) and anti-inflammatory (ibuprofen) drugs can decrease the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately after birth.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apgar score at 5 minutes < 6
- •Profound metabolic or mixed acidosis with pH < 7 in the initial blood gas
- •Evidence of encephalopathy such as coma, seizures or hypotonia
- •Evidence of multi-system compromise, in addition to encephalopathy
排除标准
- •Major congenital anomalies
- •Early sepsis
- •Gastrointestinal bleeding
- •Thrombocytopenia
研究组 & 干预措施
A
Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days
干预措施: Ascorbic acid (vitamin C) (Drug)
A
Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days
干预措施: Ibuprofen (Drug)
B
Infants will receive equivalent amount of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
DDST-II
时间窗: 6 months
Neurological Examination
时间窗: 6 months
次要结局
- Death(On Discharge)
- Neurological Examination(On Discharge)