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>