Overview

This trial is active, not recruiting.

Conditions fetal hypoxia, reperfusion injury
Treatments allopurinol sodium, mannitol
Phase phase 3
Sponsor UMC Utrecht
Collaborator ZonMw: The Netherlands Organisation for Health Research and Development
Start date October 2009
End date December 2011
Trial size 222 participants
Trial identifier NCT00189007, 170991001, 2006-005796-18, ALLO-trial, NL26516.000.09, NTR-1383, ZonMw 170991001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
500 mg allopurinol/ 50 mL water for injection intravenously
allopurinol sodium Acepurin
Allopurinol sodium 500 mg / 50 mL, intravenously, single dose
(Placebo Comparator)
500 mg mannitol/50 mL water for injection intravenously
mannitol
Mannitol 500 mg/50 mL water for injection, intravenously, single dose

Primary Outcomes

Measure
Free radical production and markers of neuronal damage
time frame: Up to 24 hours postpartum

Secondary Outcomes

Measure
Developmental outcome
time frame: Up to 5 years of age
Mortality
time frame: Up to 28 days postpartum
Severe composite morbidity
time frame: Up to 28 days postpartum

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Gestational age of 36 weeks or more - Non-reassuring CTG, significant events on the STAN-monitor AND/OR FBS < 7.20 Exclusion Criteria: - Chromosomal abnormalities

Additional Information

Official title Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?
Principal investigator Manon JN Benders, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by UMC Utrecht.