Antenatal Allopurinol During Fetal Hypoxia - Full Text View

Sponsored by:	UMC Utrecht
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00189007

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: sodium chloride 0.9%	Phase III

Drug Information available for: Chlorides Allopurinol sodium Allopurinol Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Does Antenatal Allopurinol Administration Reduce Post-Hypoxic-Ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?

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 4 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 ]

Estimated Enrollment:	220
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 500 mg allopurinol i.v.	Drug: allopurinol sodium 500 mg allopurinol sodium, intravenously, single dose
2: Placebo Comparator sodium chloride	Drug: sodium chloride 0.9% sodium chloride 0,9%, 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

Exclusion Criteria:

Chromosomal abnormalities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189007

Contacts

Contact: Manon Benders, MD PhD	31-88-7555555 ext 4545	m.benders@umcutrecht.nl
Contact: Frank van Bel, Prof MD PhD	31-88-7555555 ext 4545	f.vanbel@umcutrecht.nl

Locations

Netherlands
AMC	Not yet recruiting
Amsterdam, Netherlands
Principal Investigator: Ben Willem Mol, MD PhD
LUMC	Not yet recruiting
Leiden, Netherlands
Principal Investigator: Kitty Bloemenkamp, MD PhD
UMCG	Not yet recruiting
Groningen, Netherlands
Principal Investigator: Marielle v. Pampus, MD PhD
VUmc	Not yet recruiting
Amsterdam, Netherlands
Principal Investigator: M. Wouters, MD PhD
Wilhelmina Children's Hospital/UMC Utrecht	Recruiting
Utrecht, Netherlands, 3508AB
Contact: Manon Benders, MD PhD 0031-88-7554545 m.benders@umcutrecht.nl
Contact: Frank van Bel, Prof MD PhD 0031-88-7554545 f.vanbel@umcutrecht.nl
Principal Investigator: Manon Benders, MD PhD
Sub-Investigator: Joepe Kaandorp, MD
Principal Investigator: Jan Derks, MD PhD
Diakonessenhuis	Not yet recruiting
Utrecht, Netherlands
Principal Investigator: Janine Boon, MD PhD
Gelre hospitals	Not yet recruiting
Apeldoorn, Netherlands
Principal Investigator: Anjoke Huisjes, MD
Maxima Medical Center	Not yet recruiting
Veldhoven, Netherlands
Principal Investigator: Martina Porath, MD PhD

Sponsors and Collaborators

UMC Utrecht

Investigators

Study Director:

Frank van Bel, Prof MD PhD

Wilhelmina Children's Hospital/UMC Utrecht

More Information

Additional Information:

website allo-trial This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UMC Utrecht ( Prof. Dr. F. van Bel )
Study ID Numbers:	METC UMCU 03-217, ALLO-trial
Study First Received:	September 11, 2005
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00189007 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:

allopurinol
neuroprotection
reperfusion injury
fetal hypoxia
post hypoxic-ischemic reperfusion damage

Study placed in the following topic categories:

Antimetabolites
Allopurinol
Antioxidants
Fetal Hypoxia
Pregnancy Complications
Vascular Diseases
Ischemia

Anoxia
Signs and Symptoms
Fetal Diseases
Postoperative Complications
Signs and Symptoms, Respiratory
Antirheumatic Agents
Reperfusion Injury

Additional relevant MeSH terms:

Antimetabolites
Allopurinol
Antioxidants
Fetal Hypoxia
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Enzyme Inhibitors
Protective Agents
Gout Suppressants
Pharmacologic Actions

Anoxia
Signs and Symptoms
Fetal Diseases
Pathologic Processes
Postoperative Complications
Therapeutic Uses
Free Radical Scavengers
Signs and Symptoms, Respiratory
Cardiovascular Diseases
Antirheumatic Agents
Reperfusion Injury

ClinicalTrials.gov processed this record on May 07, 2009