Maternal allopurinol administration during suspected fetal hypoxia: a novel neuroprotective intervention? A multicentre randomised placebo controlled trial
| Autor: | Carin M. A. Rademaker, Danilo Gavilanes, Ewoud Schuit, Janine Boon, Timo R. de Haan, Joepe J. Kaandorp, Maureen T.M. Franssen, Claudia A. van Meir, Maurice G.A.J. Wouters, Kitty W. M. Bloemenkamp, Saskia C. M. J. E. R. Bakker, Liesbeth Scheepers, Inge P. de Boer, Robbert J.P. Rijnders, Martijn A. Oudijk, Sidarto Bambang Oetomo, Ruurd M. van Elburg, Corrie J. W. F. M. Jacobs, Monique Rijken, Manon J.N.L. Benders, Gerard H. A. Visser, Frank van Bel, Jeannette S von Lindern, Jan B. Derks, Arie Bos, Anjoke J.M. Huisjes, Ben W.J. Mol, Martina Porath |
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| Přispěvatelé: | Obstetrics and gynaecology, ICaR - Ischemia and repair, Other departments, ARD - Amsterdam Reproduction and Development, Obstetrics and Gynaecology, ANS - Amsterdam Neuroscience, Other Research, Neonatology, Reproductive Origins of Adult Health and Disease (ROAHD), MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Obstetrie & Gynaecologie, Epidemiologie, Kindergeneeskunde, RS: FHML non-thematic output |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male BIOMARKER Xanthine Oxidase Allopurinol Placebo-controlled study Oxypurinol S100 Calcium Binding Protein beta Subunit Placebo Dinoprost Fetal Hypoxia BRAIN-DAMAGE Double-Blind Method Pregnancy S100B PROTEIN Post-hoc analysis REGRESSION medicine Clinical endpoint Humans Enzyme Inhibitors Maternal-Fetal Exchange Aldehydes PERINATAL ASPHYXIA CEREBRAL-ISCHEMIA business.industry Obstetrics and Gynecology ENCEPHALOPATHY General Medicine Ketones medicine.disease Fetal Blood Perinatal asphyxia BIRTH ASPHYXIA BLOOD-LEVELS BIOLOGICAL-FLUIDS Anesthesia Cord blood Relative risk Pediatrics Perinatology and Child Health Female business medicine.drug |
| Zdroj: | Archives of Disease in Childhood-Fetal and Neonatal Edition, 100(3), F216-F223. BMJ Publishing Group Archives of disease in childhood. Fetal and neonatal edition, 100(3), F216-F223. BMJ Publishing Group ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION, 100(3), F216-F223. BMJ PUBLISHING GROUP Archives of Disease in Childhood-fetal and Neonatal Edition, 100(3), F216-F223. BMJ Publishing Group Archives of disease in childhood. Fetal and neonatal edition, 100(3), F216-F223 Kaandorp, J J, Benders, M J N L, Schuit, E, Rademaker, C M A, Oudijk, M A, Porath, M M, Oetomo, S B, Wouters, M G A J, van Elburg, R M, Franssen, M T M, Bos, A F, Haan, T R, Boon, J, de Boer, I P, Rijnders, R J P, Jacobs, C J W F, Scheepers, L H C J, Gavilanes, D A W, Bloemenkamp, K W M, Rijken, M, van Meir, C A, von Lindern, J S, Huisjes, A J M, Bakker, S C M J, Mo, B J, Visser, G H A, van Bel, F & Derks, J B 2015, ' Maternal allopurinol administration during suspected fetal hypoxia: a novel neuroprotective intervention? A multicentre randomised placebo controlled trial ', Archives of Disease in Childhood-Fetal and Neonatal Edition, vol. 100, no. 3, pp. F216-F223 . https://doi.org/10.1136/archdischild-2014-306769 |
| ISSN: | 1359-2998 |
| Popis: | 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 510013, 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% Cl -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% Cl 0.14 to 0.99)) but not in boys (ALLO n=18 (32%) vs CONT n=15 (25%); RR 1.4(95% Cl 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% Cl 12.1 to 26.9) in the ALLO group versus 32.2 pg/mL (95% Cl 22.7 to 45.7) in the CONT group (geometric mean difference 16.4(95% Cl 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. |
| Databáze: | OpenAIRE |
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