Clinical Trial: Cerebral Perfusion During Neonatal Cardiac Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery

Brief Summary:

Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex operations may contribute to less cerebral damage, but literature is not conclusive on this issue.

Therefore, the investigators will perform a randomised controlled trial comparing DHCA and ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological outcome.

Detailed Summary:
Sponsor: UMC Utrecht

Current Primary Outcome: New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan). [ Time Frame: Approximately 1 week postoperatively ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Mortality within 30 days [ Time Frame: 30 days postoperatively ]

Original Secondary Outcome: Same as current

Information By: UMC Utrecht

Dates:
Date Received: December 15, 2009
Date Started: January 2009
Date Completion:
Last Updated: June 28, 2012
Last Verified: June 2012