Understanding brain injury in babies after heart surgery
Paediatric Brain Injury Following Cardiac Interventions (BICI 2 Kids Study)
This study looks at how different factors might cause brain injury in newborns who have heart surgery to help improve care and outcomes for these babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT04992793 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the factors contributing to brain injury in neonates undergoing surgery for congenital heart disease within their first year of life. It will gather patient-specific physiological measurements and early outcome data to support the development of advanced neuromonitoring software designed to guide brain perfusion during surgery. The study will collect demographic, birth, and surgical risk factors, alongside intra-operative physiological data and biomarkers, to explore the complex causes of brain injury and long-term developmental issues in these infants.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under one year of age with congenital cardiac conditions who are scheduled for heart surgery.
Not a fit: Patients with known pre-existing brain conditions or genetic syndromes affecting brain development may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that may prevent brain injuries during cardiac surgeries in neonates.
How similar studies have performed: While this approach is exploratory, previous studies have indicated the importance of monitoring brain health during cardiac surgeries, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Leicester
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Emma Chung — University of Leicester
- Study coordinator: Emma Chung
- Email: RGOsponsor@le.ac.uk
- Phone: 01162584867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.