RT Journal Article
SR Electronic
T1 Maternal allopurinol administration during suspected fetal hypoxia: a novel neuroprotective intervention? A multicentre randomised placebo controlled trial
JF Archives of Disease in Childhood - Fetal and Neonatal Edition
JO Arch Dis Child Fetal Neonatal Ed
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP F216
OP F223
DO 10.1136/archdischild-2014-306769
VO 100
IS 3
A1 Joepe J Kaandorp
A1 Manon J N L Benders
A1 Ewoud Schuit
A1 Carin M A Rademaker
A1 Martijn A Oudijk
A1 Martina M Porath
A1 Sidarto Bambang Oetomo
A1 Maurice G A J Wouters
A1 Ruurd M van Elburg
A1 Maureen T M Franssen
A1 Arie F Bos
A1 Timo R de Haan
A1 Janine Boon
A1 Inge P de Boer
A1 Robbert J P Rijnders
A1 Corrie J W F M Jacobs
A1 Liesbeth H C J Scheepers
A1 Danilo A W Gavilanes
A1 Kitty W M Bloemenkamp
A1 Monique Rijken
A1 Claudia A van Meir
A1 Jeannette S von Lindern
A1 Anjoke J M Huisjes
A1 Saskia C M J E R Bakker
A1 Ben W J Mol
A1 Gerard H A Visser
A1 Frank Van Bel
A1 Jan B Derks
YR 2015
UL http://fn.bmj.com/content/100/3/F216.abstract
AB 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.