BICI 2 Kids
Research type
Research Study
Full title
Paediatric Brain Injury following Cardiac Interventions: congenital cardiac surgery
IRAS ID
251389
Contact name
Emma Chung
Contact email
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Research Summary
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.Summary of Results
: Understanding Brain Health in Babies with Heart Conditions: The BICI 2 Kids Study.
This study looked at how heart surgery affects the brain in babies with congenital heart disease (CHD). Researchers wanted to understand what changes happen in the brain before, during, and after surgery, and what might increase the risk of brain injury or later developmental problems.Who took part?
The study included babies under one year old who needed heart surgery. Babies with known brain conditions or certain genetic or inflammatory disorders were not included.What did the researchers do?
They collected information at several stages:
• Before surgery:
o Medical details from hospital records
o Brain scans using MRI (done without sedation) o Blood tests to look for signs of brain injury and inflammation o A 15-minute ultrasound to measure blood flow in the brain• During surgery:
o Details of the operation
o Monitoring of vital signs and brain oxygen levels o Brain blood flow measurements using ultrasound• After surgery:
o Medical updates from hospital records
o Repeat brain blood flow measurements and MRI scans o More blood tests for brain injury and inflammation• At 2 years old:
o Parents filled out questionnaires about their child’s development and behaviour.What did they find?
• 38 babies were included in the study. Some had surgery with a heart-lung machine (called “on-pump”), some had surgery without it (“off-pump”), and others had a less invasive procedure called cardiac catheterisation.• Blood tests showed that babies who had on-pump surgery had higher levels of markers linked to brain injury and inflammation. This might be due to experiencing longer surgery for a more severe CHD, or the effects of the heart-lung machine.
• MRI scans were planned but couldn’t be done for most babies.
• Only 10 families completed the follow-up questionnaires. These confirmed previous studies suggesting a possible link between heart procedures and developmental or behavioural challenges at 2 years of age.
Why is this important?
The results suggest that certain types of heart surgery may increase the risk of brain injury in babies. Although more research is needed, especially with larger groups, these findings could help doctors develop better ways to protect the brain during surgery and improve long-term outcomes for children with CHD.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
20/EM/0243
Date of REC Opinion
24 Nov 2020
REC opinion
Further Information Favourable Opinion