Abstract
ObjectiveTo evaluate the long-term neurodevelopmental and behavioral outcome of antenatal allopurinol treatment during suspected fetal hypoxia.Study designWe studied children born from women who participated in a randomized double-blind placebo controlled multicenter study (ALLO-trial). Labouring women in whom the fetus was suspected to have fetal hypoxia were randomly allocated to receive allopurinol or placebo. At 5 years of age, the children were assessed with 2 parent reported questionnaires, the Ages and Stages Questionnaire (ASQ) and the Child Behavior Checklist (CBCL). A child was marked abnormal for ASQ if it scored below 2 standard deviation under the normative mean of a reference population in at least one domain. For CBCL, a score above the cut-off value (95th percentile for narrowband scale, 85th percentile for broadband scale) in at least one scale was marked as abnormal.ResultsWe obtained data from 138 out of the original 222 mildly asphyxiated children included in the ALLO-trial (response rate 62%, allopurinol n = 73, placebo n = 65). At 5 years of age, the number of children that scored abnormal on the ASQ were 11 (15.1%) in the allopurinol group versus 11 (9.2%) in the placebo group (relative risk (RR) 1.64, 95% confidence interval (CI): 0.64 to 4.17, p = 0.30). On CBCL 21 children (30.4%) scored abnormal in de allopurinol group versus 12 children (20.0%) in the placebo group (RR 1.52, 95% CI: 0.82 to 2.83, p = 0.18).ConclusionWe found no proof that allopurinol administered to labouring women with suspected fetal hypoxia improved long-term developmental and behavioral outcome. These findings are limited due to the fact that the study was potentially underpowered.Trial registrationNCT00189007 Dutch Trial Register NTR1383
Highlights
Perinatal asphyxia is one of the major problems in obstetrics, carrying an incidence of 4–9 per 1000 live born neonates [1,2]
We obtained data from 138 out of the original 222 mildly asphyxiated children included in the ALLO-trial
Follow-up of the ALLO-trial allopurinol group versus 12 children (20.0%) in the placebo group (RR 1.52, 95% CI: 0.82 to 2.83, p = 0.18)
Summary
Perinatal asphyxia is one of the major problems in obstetrics, carrying an incidence of 4–9 per 1000 live born neonates [1,2]. It can lead to hypoxic-ischemic encephalopathy (HIE) of the newborn, which is strongly associated with neonatal death, cerebral palsy and cognitive disability [3]. The brain is damaged by direct ischemia, and via the production of free oxygen radicals after reoxygenation and reperfusion [5]. Allopurinol, a xanthine-oxidase inhibitor, inhibits conversion of hypoxanthine and uric acid, thereby limiting the production of free oxygen radicals. A Cochrane review from 2012 assessed that the available data are not sufficient to determine the effect of allopurinol on HIE in newborns (Composite of death or severe neurodevelopmental disability (risk ratio 0.78; 95% CI 0.56 to 1.08; risk difference -0.14; 95% CI -0.31 to 0.04))[13]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
