Overview

Antenatal Allopurinol During Fetal Hypoxia

Status:
Unknown status

Trial end date:
2016-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

UMC Utrecht

Collaborator:

ZonMw: The Netherlands Organisation for Health Research and Development

Treatments:

Allopurinol
Mannitol

Criteria

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