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KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders

Launched by UNIVERSITY HOSPITAL, LILLE · Dec 20, 2022

Trial Information

Current as of January 17, 2025

Recruiting

Keywords

Eeg Neurodevelopmental Disorders Congenital Cardiomyopathy Orality Disorders

ClinConnect Summary

The KIDSHEART AND BRAIN trial is studying how early heart surgery affects the brain development of young children with congenital heart disease. Researchers want to find out if certain brain changes can be detected through EEG (a test that measures electrical activity in the brain) shortly after surgery. This is important because many children with congenital heart disease may face neurodevelopmental disorders, such as difficulties with learning or attention, as they grow up. By identifying risk factors and early brain markers, doctors hope to provide better follow-up care tailored to each child's needs.

To be eligible for this study, children under one year old who need heart surgery at the CHU of Lille can participate. The study is looking specifically at those who will have surgery using a heart-lung machine (extracorporeal circulation) before they turn one. Unfortunately, children who have already had heart surgery, those who don't need surgery, or whose parents do not give consent cannot participate. For families involved in the study, they can expect to help researchers learn more about how to support children with congenital heart disease and improve their long-term health and quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Child of less than 1 year admitted for cardiac surgery on extracorporal circulation on the CHU of Lille during the study period.
  • Child with congenital cardiopathy with necessity to be operated before 1 year old.
  • Exclusion Criteria:
  • Child with no necessity of surgery before 1 year old.
  • Medical history of cardiac surgery.
  • Refusal of consent by the parents.
  • No social security.
  • Child not operated on the CHU of LILLE.

Trial Officials

Flavien GAUTRON, CRA

Study Chair

CHU de Lille

Gaëlle GUYOT, CRA

Study Chair

CHU de Lille

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Lille, Hauts De France, France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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