10.1371/journal.pone.0201063 Job Klumper Job Klumper Joepe J. Kaandorp Joepe J. Kaandorp Ewoud Schuit Ewoud Schuit Floris Groenendaal Floris Groenendaal Corine Koopman-Esseboom Corine Koopman-Esseboom Eduard J. H. Mulder Eduard J. H. Mulder Frank Van Bel Frank Van Bel Manon J. N. L. Benders Manon J. N. L. Benders Ben W. J. Mol Ben W. J. Mol Ruurd M. van Elburg Ruurd M. van Elburg Arend F. Bos Arend F. Bos Jan B. Derks Jan B. Derks Behavioral and neurodevelopmental outcome of children after maternal allopurinol administration during suspected fetal hypoxia: 5-year follow up of the ALLO-trial Public Library of Science 2018 Trial registration NCT 00189007 RR antenatal allopurinol treatment ALLO-trial hypoxia 5 years NTR CBCL Child Behavior Checklist ASQ CI randomized double-blind placebo outcome placebo group allopurinol group 2018-08-23 17:35:31 Dataset https://plos.figshare.com/articles/dataset/Behavioral_and_neurodevelopmental_outcome_of_children_after_maternal_allopurinol_administration_during_suspected_fetal_hypoxia_5-year_follow_up_of_the_ALLO-trial/7002176 <div><p>Objective</p><p>To evaluate the long-term neurodevelopmental and behavioral outcome of antenatal allopurinol treatment during suspected fetal hypoxia.</p><p>Study design</p><p>We 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 (95<sup>th</sup> percentile for narrowband scale, 85<sup>th</sup> percentile for broadband scale) in at least one scale was marked as abnormal.</p><p>Results</p><p>We 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).</p><p>Conclusion</p><p>We 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.</p><p>Trial registration</p><p><a href="https://clinicaltrials.gov/ct2/show/NCT00189007" target="_blank">NCT00189007</a> Dutch Trial Register NTR1383</p></div>