Cerebral Perfusion During Neonatal Cardiac Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Congenital Heart Defects, Hypoplastic Left Heart Syndrome, Aortic Coarctation

Intervention / Treatment
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* Procedure: Deep Hypothermic Circulatory Arrest
* Procedure: Antegrade Cerebral Perfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Hypothermic Circulatory Arrest<br> | Procedure: Deep Hypothermic Circulatory Arrest<br>* DHCA will be employed for a maximum of 60 minutes. If more time (>60 min) is needed for the arch reconstruction the surgeon will proceed with ACP, which will be continued for the rest of the operation (= DHCA+ACP).<br>|
| Experimental: Antegrade Cerebral Perfusion<br> | Procedure: Antegrade Cerebral Perfusion<br>* One cannula will be advanced into the brachiocephalic/ innominate artery via the usual arterial cannulation site in the aorta ascendens. A flow of 20-25% of the maximum CPB-flow will be used, which corresponds to a flow rate of 40-50 ml/ kg/ min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan). |  | Approximately 1 week postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality within 30 days |  | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Heart disease, Cardiopulmonary bypass, Neonatal brain injury, Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion