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Children born with congenital heart problems face numerous physical, developmental, and social challenges. Complications in pregnancy have potential to impair brain development, leading a smaller brain volume and less mature brain even in babies born at full term. As the brain is less mature, it may be more susceptible to oxygen deprivation and other forms of brain injury. Urgent surgery is often required in the first few weeks of life to improve functioning of the heart, but this surgery also carries a risk of additional brain injuries.
The aim of this study is to provide a better understanding of factors associated with the development of brain injury in neonates undergoing heart surgery in the first year or life. The short-term aim of this study is to provide data to help our team to develop advanced monitoring software that can be used to guide perfusion of the brain during surgery with a view to preventing surgery-related brain injury. The mid-term goal of the study is to identify risk factors associated with brain injury and inflammation around the time of surgery, through using MRI and taking blood samples. A longer term aim of this study is to be able to follow the children as they develop to see if any problems develop later in life. In this study, we will ask parents to complete two brief questionnaires when their infant reaches 2 years of age. Overall, this study aims to improve our understanding of the causes of brain injury in patients born with congenital heart problems. The data provided by this study will help us to develop new tools for monitoring brain perfusion during surgery.
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:
Intra-operative measurements
Post-operative measurements
Cognitive and behavioural follow-up at 2 years:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Congenital heart surgery | Combination Product | Paediatric congenital heart surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of brain tissue perfusion and oxygenation. | To provide preliminary data to support the development of a prototype intraoperative neuromonitoring system for personalised estimation of brain tissue perfusion and oxygenation during paediatric cardiac surgery. | During paediatric cardiac surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of modifiable risk factors | Longer-term secondary objectives of the study involve identification of modifiable risk factors associated with post-surgery brain injury and cognitive and behavioural outcomes at 2 years. A predictive statistical model will be developed based on information relating to the patient's brain blood flow management during surgery, as well as demographic factors, such as gestational age and condition at birth, treatment course, and inflammatory and brain injury biomarkers. Outcome data will include pre- and post-surgery brain MRI scans (in a sub-study of 30 patients) and cognitive and behavioural assessment at 2 years of age. |
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Inclusion Criteria:
Exclusion Criteria:
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Babies (<1 year) undergoing surgery for congenital cardiac disease
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| Name | Affiliation | Role |
|---|---|---|
| Emma Chung | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester NHS Trust | Leicester | United Kingdom |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Post surgery to 2 years |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |