Antenatal Allopurinol During Fetal Hypoxia

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

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

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• UMC Utrecht

  lead OTHER

Principal Investigators

• Frank van Bel, Prof MD PhD · Wilhelmina Children's Hospital/UMC Utrecht

• Manon JN Benders, MD, PhD · UMC Utrecht

• Jan B Derks, MD, PhD · UMC Utrecht

• Joepe J Kaandorp, MD · UMC Utrecht

• Gerard H Visser, MD, PhD · UMC Utrecht

• Ben WJ Mol, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• Carin MA Rademaker, PhD · Clinical Pharmacy, UMCU

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2011-12-31

Completion

2016-12-31

Countries

• Netherlands

Study Locations