A former study (submitted) in 32 severely asphyxiated infants participating in a randomized double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after birth) was administered to reduce free radical formation and consequently reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol. It was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with (imminent) hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
222
Allopurinol sodium 500 mg / 50 mL, intravenously, single dose
Mannitol 500 mg/50 mL water for injection, intravenously, single dose
Wilhelmina Children's Hospital/UMC Utrecht
Utrecht, Utrecht, Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
AMC
Amsterdam, Netherlands
VUmc
Amsterdam, Netherlands
Gelre hospitals
Apeldoorn, Netherlands
Groene Hart Hospital
Gouda, Netherlands
UMCG
Groningen, Netherlands
LUMC
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Diakonessenhuis
Utrecht, Netherlands
...and 1 more locations
Free radical production and markers of neuronal damage
Time frame: Up to 24 hours postpartum
Developmental outcome
Time frame: Up to 5 years of age
Mortality
Time frame: Up to 28 days postpartum
Severe composite morbidity
Time frame: Up to 28 days postpartum
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