Antenatal Allopurinol During Fetal Hypoxia

Phase 3

• Conditions: Fetal Hypoxia; Reperfusion Injury
• Interventions: Drug: Allopurinol sodium; Drug: Mannitol

• Registration Number: NCT00189007
• Lead Sponsor: UMC Utrecht

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-16
• Study Start: 2009-10
• Primary Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allopurinol	Allopurinol sodium	500 mg allopurinol/ 50 mL water for injection intravenously
Placebo	Mannitol	500 mg mannitol/50 mL water for injection intravenously

Primary Outcome Measures

Name	Time	Method
Free radical production and markers of neuronal damage	Up to 24 hours postpartum

Secondary Outcome Measures

Name	Time	Method
Developmental outcome	Up to 5 years of age
Mortality	Up to 28 days postpartum
Severe composite morbidity	Up to 28 days postpartum

Trial Locations

Locations (11)

UMCG; 🇳🇱 Groningen, Netherlands

Gelre hospitals; 🇳🇱 Apeldoorn, Netherlands

Jeroen Bosch Hospital; 🇳🇱 Den Bosch, Netherlands

Groene Hart Hospital; 🇳🇱 Gouda, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

AMC; 🇳🇱 Amsterdam, Netherlands

VUmc; 🇳🇱 Amsterdam, Netherlands

LUMC; 🇳🇱 Leiden, Netherlands

Wilhelmina Children's Hospital/UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Maxima Medical Center; 🇳🇱 Veldhoven, Netherlands