Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Antenatal Allopurinol During Fetal Hypoxia

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Diakonessenhuis
Utrecht, Netherlands
Wilhelmina Children's Hospital/UMC Utrecht
Utrecht, Netherlands, 3508AB
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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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:
Fetal Hypoxia
Reperfusion Injury
Anoxia
Cardiovascular Diseases
Fetal Diseases
Pathologic Processes
Postoperative Complications
Pregnancy Complications
Signs and Symptoms
Signs and Symptoms, Respiratory
Vascular Diseases
Allopurinol
Mannitol
Antimetabolites
Antioxidants
Antirheumatic Agents
Cardiovascular Agents
Diuretics
Diuretics, Osmotic
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014