Cerebral Perfusion During Neonatal Cardiac Surgery

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01032876
Study type	Interventional
Source	UMC Utrecht
Contact
Status	Completed
Phase	N/A
Start date	January 2009
Completion date	June 2012

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