Maternal allopurinol administration during suspected fetal hypoxia: a novel neuroprotective intervention? A multicentre randomised placebo controlled trial
dc.contributor.author | Kaandorp, J. | |
dc.contributor.author | Benders, M. | |
dc.contributor.author | Schuit, E. | |
dc.contributor.author | Rademaker, C. | |
dc.contributor.author | Oudijk, M. | |
dc.contributor.author | Porath, M. | |
dc.contributor.author | Oetomo, S. | |
dc.contributor.author | Wouters, M. | |
dc.contributor.author | van Elburg, R. | |
dc.contributor.author | Franssen, M. | |
dc.contributor.author | Bos, A. | |
dc.contributor.author | de Haan, T. | |
dc.contributor.author | Boon, J. | |
dc.contributor.author | de Boer, I. | |
dc.contributor.author | Rijnders, R. | |
dc.contributor.author | Jacobs, C. | |
dc.contributor.author | Scheepers, L. | |
dc.contributor.author | Gavilanes, D. | |
dc.contributor.author | Bloemenkamp, K. | |
dc.contributor.author | Rijken, M. | |
dc.contributor.author | et al. | |
dc.date.issued | 2015 | |
dc.description.abstract | OBJECTIVE: To determine whether maternal allopurinol treatment during suspected fetal hypoxia would reduce the release of biomarkers associated with neonatal brain damage. DESIGN: A randomised double-blind placebo controlled multicentre trial. PATIENTS: We studied women in labour at term with clinical indices of fetal hypoxia, prompting immediate delivery. SETTING: Delivery rooms of 11 Dutch hospitals. INTERVENTION: When immediate delivery was foreseen based on suspected fetal hypoxia, women were allocated to receive allopurinol 500 mg intravenous (ALLO) or placebo intravenous (CONT). MAIN OUTCOME MEASURES: Primary endpoint was the difference in cord S100ß, a tissue-specific biomarker for brain damage. RESULTS: 222 women were randomised to receive allopurinol (ALLO, n=111) or placebo (CONT, n=111). Cord S100ß was not significantly different between the two groups: 44.5 pg/mL (IQR 20.2-71.4) in the ALLO group versus 54.9 pg/mL (IQR 26.8-94.7) in the CONT group (difference in median -7.69 (95% CI -24.9 to 9.52)). Post hoc subgroup analysis showed a potential treatment effect of allopurinol on the proportion of infants with a cord S100ß value above the 75th percentile in girls (ALLO n=5 (12%) vs CONT n=10 (31%); risk ratio (RR) 0.37 (95% CI 0.14 to 0.99)) but not in boys (ALLO n=18 (32%) vs CONT n=15 (25%); RR 1.4 (95% CI 0.84 to 2.3)). Also, cord neuroketal levels were significantly lower in girls treated with allopurinol as compared with placebo treated girls: 18.0 pg/mL (95% CI 12.1 to 26.9) in the ALLO group versus 32.2 pg/mL (95% CI 22.7 to 45.7) in the CONT group (geometric mean difference -16.4 (95% CI -24.6 to -1.64)). CONCLUSIONS: Maternal treatment with allopurinol during fetal hypoxia did not significantly lower neuronal damage markers in cord blood. Post hoc analysis revealed a potential beneficial treatment effect in girls. TRIAL REGISTRATION NUMBER: NCT00189007, Dutch Trial Register NTR1383. | |
dc.description.statementofresponsibility | Joepe J Kaandorp ... Ben W J MoL ... et al. | |
dc.identifier.citation | Archives of Disease in Childhood: Fetal and Neonatal Edition, 2015; 100(3):F216-F223 | |
dc.identifier.doi | 10.1136/archdischild-2014-306769 | |
dc.identifier.issn | 1359-2998 | |
dc.identifier.issn | 1468-2052 | |
dc.identifier.orcid | Mol, B. [0000-0001-6887-0262] [0000-0001-8337-550X] | |
dc.identifier.uri | http://hdl.handle.net/2440/97631 | |
dc.language.iso | en | |
dc.publisher | BMJ Publishing Group | |
dc.rights | © 2015 BMJ Publishing Group | |
dc.source.uri | https://doi.org/10.1136/archdischild-2014-306769 | |
dc.subject | Fetal Blood | |
dc.subject | Aldehydes | |
dc.subject | Ketones | |
dc.subject | Oxypurinol | |
dc.subject | Allopurinol | |
dc.subject | Xanthine Oxidase | |
dc.subject | Dinoprost | |
dc.subject | Enzyme Inhibitors | |
dc.subject | Double-Blind Method | |
dc.subject | Maternal-Fetal Exchange | |
dc.subject | S100 Calcium Binding Protein beta Subunit | |
dc.title | Maternal allopurinol administration during suspected fetal hypoxia: a novel neuroprotective intervention? A multicentre randomised placebo controlled trial | |
dc.type | Journal article | |
pubs.publication-status | Published |