NCT00189007

Antenatal Allopurinol During Fetal Hypoxia

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fetal Hypoxia
• Reperfusion Injury

Interventions

Type	Name	Description
DRUG	Allopurinol sodium	Allopurinol sodium 500 mg / 50 mL, intravenously, single dose
DRUG	Mannitol	Mannitol 500 mg/50 mL water for injection, intravenously, single dose

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-12-01
• Completion: 2016-12-01
• First posted: 2005-09-16
• Last updated: 2012-03-29

Locations

11 sites across 1 country: Netherlands