Antenatal Allopurinol During Fetal Hypoxia

UMC Utrecht

Status and phase: Unknown; Phase 3

Conditions: Fetal Hypoxia; Reperfusion Injury

Treatments: Drug: Allopurinol sodium; Drug: Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT00189007

NL26516.000.09 (Other Identifier)

ZonMw 170991001

170991001 (Other Grant/Funding Number)

2006-005796-18 (EudraCT Number)

NTR-1383 (Registry Identifier)

ALLO-trial (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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222 participants in 2 patient groups, including a placebo group

Allopurinol

Experimental group

Description:

500 mg allopurinol/ 50 mL water for injection intravenously

Treatment:

Drug: Allopurinol sodium

Placebo

Placebo Comparator group

Description:

500 mg mannitol/50 mL water for injection intravenously

Treatment:

Drug: Mannitol