Paediatric Brain Injury Following Cardiac Interventions

NCT04992793 | Completed

• 1 other identifier: 0777
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Identification of modifiable risk factors

  Post surgery to 2 years

Interventions

Congenital heart surgery COMBINATION_PRODUCT

Paediatric congenital heart surgery

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Babies (\<1 year) undergoing surgery for congenital cardiac disease

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Emma Chung

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: September 9, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)