Antenatal Allopurinol During Fetal Hypoxia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fetal Hypoxia Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Allopurinol

500 mg allopurinol/ 50 mL water for injection intravenously

Group Type EXPERIMENTAL

Allopurinol sodium

Intervention Type DRUG

Allopurinol sodium 500 mg / 50 mL, intravenously, single dose

Placebo

500 mg mannitol/50 mL water for injection intravenously

Group Type PLACEBO_COMPARATOR

Mannitol

Intervention Type DRUG

Mannitol 500 mg/50 mL water for injection, intravenously, single dose

Interventions

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Allopurinol sodium

Allopurinol sodium 500 mg / 50 mL, intravenously, single dose

Intervention Type DRUG

Mannitol

Mannitol 500 mg/50 mL water for injection, intravenously, single dose

Intervention Type DRUG

Other Intervention Names

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Acepurin

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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dr. M.J.N.L. Benders

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank van Bel, Prof MD PhD

Role: STUDY_DIRECTOR

Wilhelmina Children's Hospital/UMC Utrecht

Manon JN Benders, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Jan B Derks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Joepe J Kaandorp, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Gerard H Visser, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Ben WJ Mol, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Carin MA Rademaker, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacy, UMCU

Locations

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Wilhelmina Children's Hospital/UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Jeroen Bosch Hospital

's-Hertogenbosch, , Netherlands

Site Status

AMC

Amsterdam, , Netherlands

Site Status

VUmc

Amsterdam, , Netherlands

Site Status

Gelre hospitals

Apeldoorn, , Netherlands

Site Status

Groene Hart Hospital

Gouda, , Netherlands

Site Status

UMCG

Groningen, , Netherlands

Site Status

LUMC

Leiden, , Netherlands

Site Status

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Diakonessenhuis

Utrecht, , Netherlands

Site Status

Maxima Medical Center

Veldhoven, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND

PMID: 20167117 (View on PubMed)

Klumper J, Kaandorp JJ, Schuit E, Groenendaal F, Koopman-Esseboom C, Mulder EJH, Van Bel F, Benders MJNL, Mol BWJ, van Elburg RM, Bos AF, Derks JB; ALLO-trial study group. Behavioral and neurodevelopmental outcome of children after maternal allopurinol administration during suspected fetal hypoxia: 5-year follow up of the ALLO-trial. PLoS One. 2018 Aug 23;13(8):e0201063. doi: 10.1371/journal.pone.0201063. eCollection 2018.

Reference Type DERIVED

PMID: 30138355 (View on PubMed)

Kaandorp JJ, Benders MJ, Schuit E, Rademaker CM, Oudijk MA, Porath MM, Oetomo SB, Wouters MG, van Elburg RM, Franssen MT, Bos AF, de Haan TR, Boon J, de Boer IP, Rijnders RJ, Jacobs CJ, Scheepers LH, Gavilanes DA, Bloemenkamp KW, Rijken M, van Meir CA, von Lindern JS, Huisjes AJ, Bakker SC, Mol BW, Visser GH, Van Bel F, Derks JB. Maternal allopurinol administration during suspected fetal hypoxia: a novel neuroprotective intervention? A multicentre randomised placebo controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F216-23. doi: 10.1136/archdischild-2014-306769. Epub 2014 Dec 15.

Reference Type DERIVED

PMID: 25512466 (View on PubMed)

Kaandorp JJ, van den Broek MP, Benders MJ, Oudijk MA, Porath MM, Bambang Oetomo S, Wouters MG, van Elburg R, Franssen MT, Bos AF, Mol BW, Visser GH, van Bel F, Rademaker CM, Derks JB; ALLO-trial Study Group. Rapid target allopurinol concentrations in the hypoxic fetus after maternal administration during labour. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F144-8. doi: 10.1136/archdischild-2013-304876. Epub 2013 Dec 18.

Reference Type DERIVED

PMID: 24352085 (View on PubMed)

Torrance HL, Benders MJ, Derks JB, Rademaker CM, Bos AF, Van Den Berg P, Longini M, Buonocore G, Venegas M, Baquero H, Visser GH, Van Bel F. Maternal allopurinol during fetal hypoxia lowers cord blood levels of the brain injury marker S-100B. Pediatrics. 2009 Jul;124(1):350-7. doi: 10.1542/peds.2008-2228.

Reference Type DERIVED

PMID: 19564319 (View on PubMed)