Antenatal Allopurinol During Fetal Hypoxia

Sponsor

UMC Utrecht (Other)

Overall Status

Unknown status

CT.gov ID

NCT00189007

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

222

Enrollment

Locations

Arms

Duration (Months)

20.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Hypoxia Reperfusion Injury	Drug: Allopurinol sodium Drug: Mannitol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

222 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Allopurinol 500 mg allopurinol/ 50 mL water for injection intravenously	Drug: Allopurinol sodium Allopurinol sodium 500 mg / 50 mL, intravenously, single dose Other Names: 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

Arm

Intervention/Treatment

Experimental: Allopurinol

500 mg allopurinol/ 50 mL water for injection intravenously

Drug: Allopurinol sodium

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

Other Names:

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

Outcome Measures

Primary Outcome Measures

Free radical production and markers of neuronal damage [Up to 24 hours postpartum]

Secondary Outcome Measures

Developmental outcome [Up to 5 years of age]
Mortality [Up to 28 days postpartum]
Severe composite morbidity [Up to 28 days postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	AMC	Amsterdam	Netherlands
2	VUmc	Amsterdam	Netherlands
3	Gelre hospitals	Apeldoorn	Netherlands
4	Jeroen Bosch Hospital	Den Bosch	Netherlands
5	Groene Hart Hospital	Gouda	Netherlands
6	UMCG	Groningen	Netherlands
7	LUMC	Leiden	Netherlands
8	Maastricht University Medical Center	Maastricht	Netherlands
9	Wilhelmina Children's Hospital/UMC Utrecht	Utrecht	Netherlands	3508AB
10	Diakonessenhuis	Utrecht	Netherlands
11	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