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...
Date First Received: September 11, 2005
Last Updated: October 1, 2007
Verified by: UMC Utrecht, June 2006
Clinical Trial Phase: N/A | Start Date: October 2004
Overall Status: Recruiting
Estimated Enrollment: 100
Brief Summary
Official Title: “Does Antenatal Allopurinol Administration Reduce Post-Hypoxic-Ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?”
Condition Keyword(s):
Intervention(s):
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, Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: allopurinol
Outcome Measures for this Clinical Trial
Primary Measures
- free radical production
Secondary Measures
- pharmacokinetics
- developmental outcome
- Time Frame: up to 4 years of age
- Time Frame: up to 4 years of age
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Gestational age of 36 weeks or more
- Signs of fetal distress such as late decelerations on fetal monitoring
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
Clinical Trial Sponsor Information
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 31-30-2504000 m.benders@azu.nl
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
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)
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
