Actively Recruiting
Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
Led by dr. M.J.N.L. Benders · Updated on 2024-05-16
236
Participants Needed
4
Research Sites
463 weeks
Total Duration
On this page
Sponsors
D
dr. M.J.N.L. Benders
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates with a confirmed prenatal or postnatal diagnosis of critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass within the first 4 weeks of life
- Informed consent provided by both parents
You will not qualify if you...
- Unable to enroll before delivery if diagnosed prenatally, or within 24 hours before surgery if diagnosed postnatally
- Uncertainty whether aortic arch anomaly requires neonatal cardiac surgery with cardiopulmonary bypass
- Gestational age below 36 weeks or birth weight under 2000 grams
- Surgery planned without cardiopulmonary bypass
- Decision made for comfort care only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9700 RB
Actively Recruiting
2
Radboud University Medical Center Nijmegen (Radboudumc)
Nijmegen, Netherlands, 6525 GA
Active, Not Recruiting
3
Erasmus Medical Center Rotterdam (Erasmus MC)
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
4
University Medical Center Utrecht (UMC Utrecht)
Utrecht, Netherlands, 3584 EA
Actively Recruiting
Research Team
M
Manon JNL Benders, Prof. MD PhD
CONTACT
M
Maaike Nijman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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