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Clinical trial Recruiting at 3 sites Phase 3 Interventional Ages Any age to 1 Month

Using Allopurinol to Protect the Brain and Heart in Newborns with Serious Heart Defects

Official title: Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass

Run by UMC Utrecht · NCT04217421 · Data updated 2026-11-12

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.

More Congenital Heart Disease trials

Quick facts

PhasePhase 3
Study typeInterventional
AgesAny age to 1 Month
SexAll
Enrollment236 (estimated)
SponsorUMC Utrecht
Academic / other
Locations4 sites (Groningen and 3 other locations)
StatusRecruiting
StartedFebruary 14, 2020
Main results expectedOctober 31, 2026
Study endsDecember 31, 2028
Registry record updatedMay 16, 2024
Trial IDNCT04217421 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who are not undergoing surgery requiring cardiopulmonary bypass or those receiving comfort care only may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have indicated that allopurinol may be effective in reducing hypoxic-ischemic brain injury, suggesting potential success for this approach.

Who can join: the full rules

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 it's running

  • University Medical Center Groningen (UMCG)
    Groningen, Netherlands     Recruiting
  • Erasmus Medical Center Rotterdam (Erasmus MC)
    Rotterdam, Netherlands     Recruiting
  • University Medical Center Utrecht (UMC Utrecht)
    Utrecht, Netherlands     Recruiting
  • Radboud University Medical Center Nijmegen (Radboudumc)
    Nijmegen, Netherlands     Active not 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.