Official Title: “Does Antenatal Allopurinol Administration Reduce Post-Hypoxic-Ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: allopurinol sodium
  • 500 mg allopurinol sodium, intravenously, single dose
• Drug: sodium chloride 0.9%
  • sodium chloride 0,9%, intravenously, single dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 500 mg allopurinol i.v.
• Placebo Comparator: 2
  • sodium chloride

Primary Measures

• Free radical production and markers of neuronal damage
  • Time Frame: Up to 24 hours postpartum
    Safety Issue?: No

Secondary Measures

• Developmental outcome
  • Time Frame: Up to 4 years of age
    Safety Issue?: No
• Mortality
  • Time Frame: Up to 28 days postpartum
    Safety Issue?: Yes
• Severe composite morbidity
  • Time Frame: Up to 28 days postpartum
    Safety Issue?: Yes

Inclusion Criteria:

• Gestational age of 36 weeks or more
• Non-reassuring CTG

Exclusion Criteria:

• Chromosomal abnormalities

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UMC Utrecht

Overall Clinical Trial Officials and Contacts

Frank van Bel, Prof MD PhD Study Director Wilhelmina Children's Hospital/UMC Utrecht  

Overall Contact: Manon Benders, MD PhD 31-88-7555555 m.benders@umcutrecht.nl

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00189007

Study ID Number: METC UMCU 03-217

ClinicalTrials.gov Identifier: NCT00189007

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

website allo-trial