Perinatal allopurinol trial for reduction of birth asphyxia induced brain damage.

Completed

Conditions: perinatal asphyxia, neuroprotection, allopurinol, newborn, oxidative stress

Registration Number: NL-OMON28692

Lead Sponsor: Prof dr. F. van Bel

Brief Summary: Van Bel F, Shadid M, Moison RM, Dorrepaal CA, Fontijn J, Monteiro L, Van De Bor M, Berger HM. Effect of allopurinol on postasphyxial free radical formation, cerebral hemodynamics, and electrical brain activity. Pediatrics. 1998 Feb;101(2):185-93. Shadid M, Moison R, Steendijk P, Hiltermann L, Berger HM, van Bel F. The effect of antioxidative combination therapy on post hypoxic-ischemic perfusion, metabolism, and electrical activity of the newborn brain. Pediatr Res. 1998 Jul;44(1):119-24. Benders MJ, Bos AF, RademakerCM etal. Early postnatal allurinol does not improve short term outcome after severe birth asphyxia. Arch Dis Child Fetal neonatal Ed 2006:91:163-165 Kaandorp JJ, Benders MJ, Rademaker CM, Torrance HL, Oudijk MA, de Haan TR, Bloemenkamp KW, Rijken M, van Pampus MG, Bos AF, Porath MM, Oetomo SB, Willekes C, Gavilanes AW, Wouters MG, van Elburg RM, Huisjes AJ, Bakker SC, van Meir CA, von Lindern J, Boon J, de Boer IP, Rijnders RJ, Jacobs CJ, Uiterwaal CS, Mol BW, Visser GH, van Bel F, Derks JB. Antenatal allopurinol for reduction of birth asphyxia induced brain damage (ALLO-Trial); a randomized double blind placebo controlled multicenter study. BMC Pregnancy and Childbirth 2010;10:8. Kaandorp JJ, van Bel F, Veen S, Derks JB, Groenendaal F, Rijken M, Roze E, Uniken Venema MMA, Rademaker CMA, Bos AF and Benders MJNL. Long-term neuroprotective effects of allopurinol after moderate perinatal asphyxia. Follow-up of two randomised controlled trials. Arch Dis Child Fetal Neonatal Ed. 2011 Nov 17.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

1. Gestational age of 36 weeks or more, determined by maternal dates and/or Ballard score.

2. Objective fetal hypoxia registered by:

Exclusion Criteria

1. Congenital, chromosomal or syndromal malformations.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The brain damage marker S100B and the severity of oxidative stress measured in umbilical cord blood and neonatal blood (isoprostane, neuroprostane, non protein bound iron).

Secondary Outcome Measures