Using Allopurinol to Protect the Brain and Heart in Newborns with Serious Heart Defects
Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
This study is testing if giving allopurinol to newborns with serious heart defects before and after heart surgery can help protect their brains and hearts from damage.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | N/A to 1 Month |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 4 sites (Groningen and 3 other locations) |
| Trial ID | NCT04217421 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of allopurinol, a medication that reduces harmful free radicals, in neonates diagnosed with critical congenital heart disease (CCHD) who require cardiac surgery with cardiopulmonary bypass. The aim is to prevent neurodevelopmental impairments caused by brain injury during and after surgery. By administering allopurinol early in the postnatal and perioperative periods, researchers hope to limit brain and heart damage associated with hypoxia-reperfusion injury. The study will involve monitoring the outcomes of neonates receiving this treatment compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are neonates with a confirmed diagnosis of critical congenital heart disease requiring cardiac surgery within the first four weeks of life.
Not a fit: Patients who are not undergoing surgery requiring cardiopulmonary bypass or those receiving comfort care only may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce brain injury and improve long-term neurodevelopmental outcomes in neonates with critical congenital heart disease.
How similar studies have performed: Previous studies have indicated that allopurinol may be effective in reducing hypoxic-ischemic brain injury, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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".
Where this trial is running
Groningen and 3 other locations
- University Medical Center Groningen (UMCG) — Groningen, Netherlands (Recruiting)
- Radboud University Medical Center Nijmegen (Radboudumc) — Nijmegen, Netherlands (Active_not_recruiting)
- Erasmus Medical Center Rotterdam (Erasmus MC) — Rotterdam, Netherlands (Recruiting)
- University Medical Center Utrecht (UMC Utrecht) — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Manon JNL Benders, Prof. MD PhD — University Medical Center Utrecht (UMC Utrecht)
- Study coordinator: Manon JNL Benders, Prof. MD PhD
- Email: m.benders@umcutrecht.nl
- Phone: 0031887554545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.