Cerebral Perfusion During Neonatal Cardiac Surgery

U

UMC Utrecht

Status

Completed

Conditions

Congenital Heart Defects
Hypoplastic Left Heart Syndrome
Aortic Coarctation

Treatments

Procedure: Antegrade Cerebral Perfusion
Procedure: Deep Hypothermic Circulatory Arrest

Study type

Interventional

Funder types

Other

Identifiers

NCT01032876
08-090/K

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

Under 4 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

37 participants in 2 patient groups

Deep Hypothermic Circulatory Arrest
Experimental group
Treatment:
Procedure: Deep Hypothermic Circulatory Arrest
Antegrade Cerebral Perfusion
Experimental group
Treatment:
Procedure: Antegrade Cerebral Perfusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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