Paediatric Brain Injury Following Cardiac Interventions

This is a prospective observational exploratory study with the main aim of gathering patient-specific physiological measurements, and early outcome data to support the development of brain neuromonitoring software. We will use this as an opportunity to explore the complex and multi-factorial causes of brain injury and long-term developmental issues in babies undergoing surgery to correct a congenital cardiac condition under one year of age. Demographic, birth, and surgery/PICU risk factors for brain injury identified from a systematic review of previous literature will be recorded. These data will be accompanied by assessment of early post-operative outcomes, intra-operative physiological, blood and neuro monitoring, and assessment of blood and imaging biomarkers.

Specific information recorded or measured as part of this study will include:

Baseline pre-operative procedures:

• Demographic and delivery data will be obtained from the patient's medical records .
• Additional measurement of baseline brain blood flow (Middle Cerebral Artery Cerebral Blood Flow velocity (MCA CBFv)) using Transcranial Doppler (TCD) ultrasound.
• Preoperative brain MRI (obtained without an additional anesthetic or sedation using a feed and swaddle method).
• Blood test; for brain injury and inflammation biomarkers.

Intra-operative measurements

• Operative transcript and relevant surgery information obtained from the patient's notes.
• Routine intraoperative monitoring, including blood analysis, vital signs monitoring, and cerebral oxygenation measurements will be recorded to a laptop for further analysis.
• Continuous measurement of brain blood flow (Middle Cerebral Artery Cerebral Blood Flow velocity (MCA CBFv)) will be performed using Transcranial Doppler (TCD) ultrasound.

Post-operative measurements

• Information reflecting early post-operative outcome will be recorded from the patient's notes.
• Additional measurements of baseline brain blood flow (Middle Cerebral Artery Cerebral Blood Flow velocity (MCA CBFv)) using Transcranial Doppler (TCD) ultrasound will be obtained in the Paediatric Intensive Care Unit.
• Post-operative brain MRI will be obtained without an additional anesthetic or sedation using a feed and swaddle method as soon as the patient is stable and considered well enough to undergo an MRI scan. This decision will be made by the patient's consultant.
• Blood test; for brain injury and inflammation biomarkers.

Cognitive and behavioural follow-up at 2 years:

• Parent-completed Questionnaire (PARCA-R).
• Parent-completed Strengths and Difficulties Questionnaire (SDQ)
• Review of medical notes.

Inclusion criteria

• Parents/Carers should be willing to provide written informed consent for their child to participate in the study
• Patients should be under 1 year of age.
• Patients with congenital cardiac conditions of any type and severity can be included
• Patients undergo cardiac surgery (any strategy).

Exclusion criteria

• Unable (in the investigator's opinion) to comply with the study requirements.
• Known pre-existing brain conditions, and genetic or inflammatory syndromes known to affect brain development.