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临床试验/NCT00189007
NCT00189007Unknown3 期

Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?

UMC Utrecht11 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

500 mg allopurinol/ 50 mL water for injection intravenously

干预措施: Allopurinol sodium (Drug)

Placebo

Placebo Comparator

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)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. M.J.N.L. Benders

MD, PhD

UMC Utrecht

研究点 (11)

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