Cerebral Perfusion During Neonatal Cardiac Surgery

Not Applicable

Completed

• Conditions: Congenital Heart Defects; Hypoplastic Left Heart Syndrome; Aortic Coarctation
• Interventions: Procedure: Deep Hypothermic Circulatory Arrest; Procedure: Antegrade Cerebral Perfusion

• Registration Number: NCT01032876
• Lead Sponsor: UMC Utrecht

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 Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Aortic arch reconstruction (diagnosis of hypoplastic left heart syndrome, hypoplastic aortic arch, severe coarctation and/ or interrupted aortic arch)
• Infants <4 months old

Exclusion Criteria

• Anticipated arch reconstruction time longer than 60 minutes
• Sedation and intubation especially for the pre-operative MRI-scan of this research project
• Participation in another clinical trial
• Failure of data collection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Hypothermic Circulatory Arrest	Deep Hypothermic Circulatory Arrest	-
Antegrade Cerebral Perfusion	Antegrade Cerebral Perfusion	-

Primary Outcome Measures

Name	Time	Method
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).	Approximately 1 week postoperatively

Secondary Outcome Measures

Name	Time	Method
Mortality within 30 days	30 days postoperatively

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands