CeRebrUm and CardIac protection with ALlopurinol in Neonates with Critical Congenital Heart Disease requiring Cardiac Surgery with Cardiopulmonary Bypass

Conditions

Brain injury in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass.

Brief summary

Primary outcome is a composite endpoint of relevant (moderate / severe) parenchymatous brain injury on postoperative MRI or too instable for postoperative MRI or mortality.

Detailed description

Brain injury severity score and volume of hypoxic-ischemic brain injury (pre- and postoperative MRI), Brain function: background pattern and seizure activity (postnatal and perioperative amplitude integrated electroencephalogram)., Cerebral oxygenation (postnatal and perioperative near-infrared spectroscopy)., Cardiac function (pre- and postoperative echocardiography)., Neurodevelopmental outcome (general movements at 3 months and Bayley scales of infant development and executive functioning testing at 24 months)., Quality of life (TNO-TAPQOL at 24 months), Cost effectiveness of allopurinol (questionnaires during hospital stay at 3 and 24 months), Pharmacokinetics of allopurinol (substudy: postnatally, perioperatively)

Related papers

No related papers found yet.

Interventions

DRUGPlacebo Mannitol 100mg pfi

DRUGACEPURIN

DRUGpoeder voor infusievloeistof 1g/100 ml

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Primary outcome is a composite endpoint of relevant (moderate / severe) parenchymatous brain injury on postoperative MRI or too instable for postoperative MRI or mortality.	—

Secondary

Measure	Time frame
Brain injury severity score and volume of hypoxic-ischemic brain injury (pre- and postoperative MRI), Brain function: background pattern and seizure activity (postnatal and perioperative amplitude integrated electroencephalogram)., Cerebral oxygenation (postnatal and perioperative near-infrared spectroscopy)., Cardiac function (pre- and postoperative echocardiography)., Neurodevelopmental outcome (general movements at 3 months and Bayley scales of infant development and executive functioning testing at 24 months)., Quality of life (TNO-TAPQOL at 24 months), Cost effectiveness of allopurinol (questionnaires during hospital stay at 3 and 24 months), Pharmacokinetics of allopurinol (substudy: postnatally, perioperatively)	—

Measure

Time frame

Brain injury severity score and volume of hypoxic-ischemic brain injury (pre- and postoperative MRI), Brain function: background pattern and seizure activity (postnatal and perioperative amplitude integrated electroencephalogram)., Cerebral oxygenation (postnatal and perioperative near-infrared spectroscopy)., Cardiac function (pre- and postoperative echocardiography)., Neurodevelopmental outcome (general movements at 3 months and Bayley scales of infant development and executive functioning testing at 24 months)., Quality of life (TNO-TAPQOL at 24 months), Cost effectiveness of allopurinol (questionnaires during hospital stay at 3 and 24 months), Pharmacokinetics of allopurinol (substudy: postnatally, perioperatively)

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Countries

Netherlands

Outcome results

None listed