Antenatal Allopurinol During Fetal Hypoxia
This study is ongoing, but not recruiting participants.
Sponsor:
UMC Utrecht
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
dr. M.J.N.L. Benders, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00189007
First received: September 11, 2005
Last updated: March 28, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fetal Hypoxia Reperfusion Injury |
Drug: Allopurinol sodium Drug: Mannitol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn? |
Resource links provided by NLM:
Further study details as provided by UMC Utrecht:
Primary Outcome Measures:
- Free radical production and markers of neuronal damage [ Time Frame: Up to 24 hours postpartum ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Developmental outcome [ Time Frame: Up to 5 years of age ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: Up to 28 days postpartum ] [ Designated as safety issue: Yes ]
- Severe composite morbidity [ Time Frame: Up to 28 days postpartum ] [ Designated as safety issue: Yes ]
| Enrollment: | 222 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Allopurinol
500 mg allopurinol/ 50 mL water for injection intravenously
|
Drug: Allopurinol sodium
Allopurinol sodium 500 mg / 50 mL, intravenously, single dose
Other Name: Acepurin
|
|
Placebo Comparator: Placebo
500 mg mannitol/50 mL water for injection intravenously
|
Drug: Mannitol
Mannitol 500 mg/50 mL water for injection, intravenously, single dose
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189007
Locations
| Netherlands | |
| AMC | |
| Amsterdam, Netherlands | |
| VUmc | |
| Amsterdam, Netherlands | |
| Gelre hospitals | |
| Apeldoorn, Netherlands | |
| Jeroen Bosch Hospital | |
| Den Bosch, Netherlands | |
| Groene Hart Hospital | |
| Gouda, Netherlands | |
| UMCG | |
| Groningen, Netherlands | |
| LUMC | |
| Leiden, Netherlands | |
| Maastricht University Medical Center | |
| Maastricht, Netherlands | |
| Wilhelmina Children's Hospital/UMC Utrecht | |
| Utrecht, Netherlands, 3508AB | |
| Diakonessenhuis | |
| Utrecht, Netherlands | |
| Maxima Medical Center | |
| Veldhoven, Netherlands | |
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Study Director: | Frank van Bel, Prof MD PhD | Wilhelmina Children's Hospital/UMC Utrecht |
| Principal Investigator: | Manon JN Benders, MD, PhD | UMC Utrecht |
| Principal Investigator: | Jan B Derks, MD, PhD | UMC Utrecht |
| Principal Investigator: | Joepe J Kaandorp, MD | UMC Utrecht |
| Principal Investigator: | Gerard H Visser, MD, PhD | UMC Utrecht |
| Principal Investigator: | Ben WJ Mol, MD, PhD | Academic Medical Center, Amsterdam |
| Principal Investigator: | Carin MA Rademaker, PhD | Clinical Pharmacy, UMCU |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | dr. M.J.N.L. Benders, MD, PhD, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00189007 History of Changes |
| Other Study ID Numbers: | ZonMw 170991001, ALLO-trial, 2006-005796-18, 170991001, NTR-1383, NL26516.000.09 |
| Study First Received: | September 11, 2005 |
| Last Updated: | March 28, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Ministry of Health, Welfare and Sport |
Keywords provided by UMC Utrecht:
|
allopurinol neuroprotection reperfusion injury fetal hypoxia post hypoxic-ischemic reperfusion damage |
Additional relevant MeSH terms:
|
Reperfusion Injury Anoxia Fetal Hypoxia Vascular Diseases Cardiovascular Diseases Postoperative Complications Pathologic Processes Signs and Symptoms, Respiratory Signs and Symptoms Fetal Diseases Pregnancy Complications Allopurinol Mannitol Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs Diuretics, Osmotic Diuretics Natriuretic Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 13, 2013