NCT04217421 Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
| NCT ID | NCT04217421 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | dr. M.J.N.L. Benders |
| Condition | Congenital Heart Disease in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2020-02-14 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 236 participants in total. It began in 2020-02-14 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.
Eligibility Criteria
Inclusion Criteria: * Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of life. * Informed consent provided by both parents. Exclusion Criteria: * Inability to enroll the patient before the start of delivery in case of prenatal diagnosis, or 24 hours before surgery in case of 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. * Surgery not requiring cardiopulmonary bypass. * Decision for "comfort care only".
Contact & Investigator
Manon JNL Benders, Prof. MD PhD
PRINCIPAL INVESTIGATOR
University Medical Center Utrecht (UMC Utrecht)
Frequently Asked Questions
Who can join the NCT04217421 clinical trial?
This trial is open to participants of all sexes, up to 1 Month, studying Congenital Heart Disease in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04217421 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 236 participants.
Is NCT04217421 currently recruiting?
Yes, NCT04217421 is actively recruiting participants. Contact the research team at m.benders@umcutrecht.nl for enrollment information.
Where is the NCT04217421 trial being conducted?
This trial is being conducted at Groningen, Netherlands, Nijmegen, Netherlands, Rotterdam, Netherlands, Utrecht, Netherlands.
Who is sponsoring the NCT04217421 clinical trial?
NCT04217421 is sponsored by dr. M.J.N.L. Benders. The principal investigator is Manon JNL Benders, Prof. MD PhD at University Medical Center Utrecht (UMC Utrecht). The trial plans to enroll 236 participants.