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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


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
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