Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
Launched by DR. M.J.N.L. BENDERS · Dec 31, 2019
Trial Information
Current as of July 28, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a medication called allopurinol in newborns who have critical congenital heart disease (CCHD) and need heart surgery. CCHD is a serious condition that can cause problems with the brain and development due to lack of oxygen during and after surgery. Allopurinol is believed to help protect the brain and heart by reducing harmful substances in the body that can cause damage during surgery. The goal of this study is to see if giving allopurinol to these babies right after birth and during surgery can improve their outcomes.
To participate in this trial, babies must be diagnosed with CCHD and require surgery within the first month of life. Both parents need to give their consent for the baby to be part of the study. Unfortunately, babies who are born too early, weigh less than a certain amount, or are not expected to undergo surgery will not be eligible. If enrolled, families can expect to closely monitor the baby's health during the study to see how well allopurinol works in protecting their brain and heart. This trial is currently looking for participants, and it aims to provide valuable information that could help improve care for infants with this serious condition.
Gender
ALL
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".
About Dr. M.J.N.L. Benders
Dr. M.J.N.L. Benders is a distinguished clinical trial sponsor known for advancing medical research through innovative studies and a commitment to high ethical standards. With a focus on pediatric and neonatal care, Dr. Benders leads initiatives that aim to improve treatment outcomes and enhance patient safety. Leveraging a collaborative approach, Dr. Benders works with multidisciplinary teams to ensure rigorous methodology and comprehensive data analysis, ultimately contributing to the development of effective therapies and a better understanding of complex health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam, , Netherlands
Leiden, , Netherlands
Amsterdam, , Netherlands
Groningen, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Patients applied
Trial Officials
Manon JNL Benders, Prof. MD PhD
Principal Investigator
University Medical Center Utrecht (UMC Utrecht)
Johannes (Hans) MPJ Breur, MD PhD
Principal Investigator
University Medical Center Utrecht (UMC Utrecht)
Nicolaas (Koos) JG Jansen, MD PhD
Study Director
University Medical Center Utrecht (UMC Utrecht)
Raymond Stegeman, MD
Study Director
University Medical Center Utrecht (UMC Utrecht)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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