Does antenatal allopurinol during asphyxia reduce post-hypoxic-ischemic reperfusion damage in the newborn? - ALLO-trial

Active, not recruiting

• Conditions: Perinatal asphyxia; MedDRA version: 9.1Level: LLTClassification code 10004943Term: Birth asphyxia; MedDRA version: 9.1Level: LLTClassification code 10014633Term: Encephalopathy neonatal

• Registration Number: EUCTR2006-005796-18-NL
• Lead Sponsor: WKZ / UMC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Gestational age of 36 weeks or more, determined by maternal dates and/or Ballard score.
• Objective fetal hypoxia registered by:
? Abnormalities on STAN S21 fetal electrocardiography monitor (Neoventa Medical, Gothenborg, Sweden). OR
? Two or more suboptimal CTG recordings (according to CTG-classification) OR
? An abnormal / preterminal CTG recording (according to CTG-classification, see page 10) OR
? Fetal blood sampling: pH<7.20

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Congenital, chromosomal or syndromal malformations.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Fetuses with hypoxic-ischemia whose mothers are subsequently prenatally treated with 500 mg (iv) allopurinol will have a reduction in free radical-induced post-asphyxial reperfusion damage of brain and heart. Furthermore, they will have a better neurological outcome as compared to placebo-treated neonates.;Secondary Objective: ;Primary end point(s): Allopurinol treated infants will have less free radical production and lower values of markers of neuronal damage compared to placebo treated infants.