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CeRebrUm and CardIac protection with ALlopurinol in Neonates with Critical Congenital Heart Disease requiring Cardiac Surgery with Cardiopulmonary Bypass
EU CTIS ID: 2024-513041-37-00
What this study is testing
To evaluate whether in newborns with critical congenital heart disease, early postnatal (after birth) and perioperative (around cardiac surgery with cardiopulmonary bypass) allopurinol compared to placebo (mannitol) administration reduces relevant (moderate / severe) parenchymatous brain injury on postoperative MRI.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Inability to enroll the patient before the start of delivery, in case of prenatal diagnosis or 24h before surgery in case op postnatal diagnosis.
- Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period.
- Gestational age below 36 weeks and /or birth weight less than 2000 gram.
- Patient considered "moribund".
- Decision for "comfort care only"
- Surgery not requiring cardiopulmonary bypass.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.