Antenatal Allopurinol During Fetal Hypoxia

Reperfusion Injury Clinical Trial

Official title:

Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00189007
• Other study ID #: ZonMw 170991001
• Secondary ID: ALLO-trial2006-0
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 11, 2005
• Last updated: March 28, 2012
• Start date: October 2009
• Est. completion date: December 2016

Study information

• Verified date: March 2012
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 222
• Est. completion date: December 2016
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Hypoxia
• Reperfusion Injury

Intervention

Drug:
• Allopurinol sodium
Allopurinol sodium 500 mg / 50 mL, intravenously, single dose
• Mannitol
Mannitol 500 mg/50 mL water for injection, intravenously, single dose

Locations

Country	Name	City	State
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	Maxima Medical Center	Veldhoven

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Kaandorp JJ, Benders MJ, Rademaker CM, Torrance HL, Oudijk MA, de Haan TR, Bloemenkamp KW, Rijken M, van Pampus MG, Bos AF, Porath MM, Oetomo SB, Willekes C, Gavilanes AW, Wouters MG, van Elburg RM, Huisjes AJ, Bakker SC, van Meir CA, von Lindern J, Boon J, de Boer IP, Rijnders RJ, Jacobs CJ, Uiterwaal CS, Mol BW, Visser GH, van Bel F, Derks JB. Antenatal allopurinol for reduction of birth asphyxia induced brain damage (ALLO-Trial); a randomized double blind placebo controlled multicenter study. BMC Pregnancy Childbirth. 2010 Feb 18;10:8. doi: 10.1186/1471-2393-10-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free radical production and markers of neuronal damage		Up to 24 hours postpartum	No
Secondary	Developmental outcome		Up to 5 years of age	No
Secondary	Mortality		Up to 28 days postpartum	Yes
Secondary	Severe composite morbidity		Up to 28 days postpartum	Yes

External Links

•   website allo-trial