Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?
试验速览
- 阶段
- 3 期
- 发起方
- UMC Utrecht
- 入组人数
- 222
- 试验地点
- 11
- 主要终点
- Free radical production and markers of neuronal damage
研究概览
简要总结
A former study (submitted) in 32 severely asphyxiated infants participating in a randomized double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after birth) was administered to reduce free radical formation and consequently reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol. It was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with (imminent) hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age of 36 weeks or more
- •Non-reassuring CTG, significant events on the STAN-monitor AND/OR FBS < 7.20
排除标准
- •Chromosomal abnormalities
研究组 & 干预措施
Allopurinol
500 mg allopurinol/ 50 mL water for injection intravenously
干预措施: Allopurinol sodium (Drug)
Placebo
500 mg mannitol/50 mL water for injection intravenously
干预措施: Mannitol (Drug)
结局指标
主要结局
Free radical production and markers of neuronal damage
时间窗: Up to 24 hours postpartum
次要结局
- Developmental outcome(Up to 5 years of age)
- Mortality(Up to 28 days postpartum)
- Severe composite morbidity(Up to 28 days postpartum)
