Does antenatal allopurinol during perinatal asphyxia reduce post-hypoxic-ischemic reperfusion damage in the newborn? A double blind randomised placebo controlled multicenter trial.

Phase 3

Completed

• Conditions: brain damage; Encephalopathy; 10010335; 10028920

• Registration Number: NL-OMON36929
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

Pregnant women with a gestational age of at least 36 weeks, suspicion of fetal distress / intra-uterine asphyxia

Exclusion Criteria

Congenital, chromosomal or syndromal malformations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is the protein S100B, a marker for neuronal damage,<br /><br>together with the severity of oxidative stress as measured in umbilical cord<br /><br>blood en neonatal blood (for example non protein bound iron, neuroprostane). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are neonatal mortality and serious composite morbidity<br /><br>(admission, convulsions, Sarnat-score). Farmacodynamics of allopurinol will<br /><br>also be investigated.</p><br>