Congenital Heart DiseaseBICI2KidsNCT04992793
Paediatric Brain Injury Following Cardiac Interventions
An observational study of Congenital Heart Disease, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Congenital heart surgery
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2021to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Babies (<1 year) undergoing surgery for congenital cardiac disease
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester
About this study
Official title: Paediatric Brain Injury Following Cardiac Interventions (BICI 2 Kids Study)
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.
Read the detailed description
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.
- Conditions
- Congenital Heart Disease
- Being tested
- Congenital heart surgery
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Congenital heart surgeryCombination product
Paediatric congenital heart surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During paediatric cardiac surgery
Secondary outcomes (1)
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.
Measured: Post surgery to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start9 Sep 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma Chung, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992793
- Sponsor's protocol ID
- 0777
- Acronym
- BICI2Kids
- Status last verified
- Feb 2026
- First submitted
- 28 Jul 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Brain Injury Following Cardiac Interventions (BICI 2 Kids Study)
- ClinicalTrials.gov ID
- NCT04992793
- Acronym / sponsor ID
- BICI2Kids / 0777
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies (<1 year) undergoing surgery for congenital cardiac disease
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Congenital heart surgeryPaediatric congenital heart surgery | Combination product | – |
Primary outcome
Estimation of brain tissue perfusion and oxygenation.
Time frame: During paediatric cardiac surgery
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.
1 secondary outcome
Identification of modifiable risk factors
Time frame: Post surgery to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Chung principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of brain tissue perfusion and oxygenation. (time frame: During paediatric cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.