ALLOPURINOL SODIUM for Neonatal brain injury|Critical congenital heart disease

Inclusion criteria

• {"criterion_text":"-Neonates with a prenatally (before birth) or postnatally (after birth) confirmed diagnosis of critical congenital heart disease requiring neonatal cardiac surgery with cardiopulmonary bypass within the first 4 weeks of life"}

Exclusion criteria

• {"criterion_text":"-Inability to enroll the patient before the start of delivery, in case of prenatal diagnosis or 24h before surgery in case op postnatal diagnosis."}
• {"criterion_text":"-Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period."}
• {"criterion_text":"-Gestational age below 36 weeks and /or birth weight less than 2000 gram."}
• {"criterion_text":"-Patient considered \"moribund\"."}
• {"criterion_text":"-Decision for \"comfort care only\""}
• {"criterion_text":"-Surgery not requiring cardiopulmonary bypass."}

Primary endpoints

• {"endpoint_text":"-Primary outcome is a composite endpoint of relevant (moderate / severe) parenchymatous brain injury on postoperative MRI or too instable for postoperative MRI or mortality.","definition_or_measurement_approach":"Composite measured by postoperative brain MRI assessing moderate/severe parenchymatous brain injury; or classification if the patient is clinically too unstable to undergo postoperative MRI; or all-cause mortality."}

Secondary endpoints

• {"endpoint_text":"-Brain injury severity score and volume of hypoxic-ischemic brain injury (pre- and postoperative MRI)","definition_or_measurement_approach":"Pre- and postoperative MRI to assess brain injury severity score and quantify volume of hypoxic-ischemic injury."}
• {"endpoint_text":"-Brain function: background pattern and seizure activity (postnatal and perioperative amplitude integrated electroencephalogram).","definition_or_measurement_approach":"Amplitude-integrated electroencephalogram recordings postnatally and perioperatively to evaluate background pattern and seizure activity."}
• {"endpoint_text":"-Cerebral oxygenation (postnatal and perioperative near-infrared spectroscopy).","definition_or_measurement_approach":"Near-infrared spectroscopy measurements postnatally and perioperatively to assess cerebral oxygenation."}
• {"endpoint_text":"-Cardiac function (pre- and postoperative echocardiography).","definition_or_measurement_approach":"Echocardiography performed pre- and postoperatively to evaluate cardiac function."}
• {"endpoint_text":"-Neurodevelopmental outcome (general movements at 3 months and Bayley scales of infant development and executive functioning testing at 24 months).","definition_or_measurement_approach":"General movements assessment at 3 months; Bayley Scales of Infant Development and executive functioning tests at 24 months to assess neurodevelopment."}
• {"endpoint_text":"-Quality of life (TNO-TAPQOL at 24 months)","definition_or_measurement_approach":"TNO-TAPQOL questionnaire administered at 24 months to assess quality of life."}
• {"endpoint_text":"-Cost effectiveness of allopurinol (questionnaires during hospital stay at 3 and 24 months)","definition_or_measurement_approach":"Health economics questionnaires administered during hospital stay and at 3 and 24 months to evaluate cost-effectiveness."}
• {"endpoint_text":"-Pharmacokinetics of allopurinol (substudy: postnatally, perioperatively)","definition_or_measurement_approach":"Pharmacokinetic sampling in a substudy postnatally and perioperatively to characterize allopurinol PK."}

Netherlands

Earliest CTIS Part Ii Submission Date

25-07-2024

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

623

Number Of Sites

3

Number Of Participants

236

Primary sponsor

Full Name

Universitair Medisch Centrum Utrecht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands