Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Jan 27, 2021

Keywords

ClinConnect Summary

This clinical trial is examining how the timing of surgery affects the brain development and overall health of newborns with complex congenital heart disease (CCHD). The researchers want to find out if having surgery at a younger age leads to better or worse outcomes for the baby's brain and body after the operation. They will also look at whether the age at surgery is linked to any complications that might arise during or after the procedure, as well as how long the babies need to stay in the hospital.

To be eligible for this study, babies must be 2 months old or younger and have specific types of CCHD that require surgery with a special heart-lung machine during their first two months of life. Both parents will need to give their permission for the baby to participate, and the family should be covered by health insurance. If you are considering this study for your baby, please know that it aims to improve understanding of how surgical timing can impact health outcomes for infants with heart conditions.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • Patients aged 2 months or less with complex congenital heart disease (CCHD) requiring surgery with cardiac circulation during their first 2 months of life
• • Eligible heart diseases: Transposition of the Large Vessels (TGV), hypoplasia of the left ventricle, right ventricle with double outlet type Fallot or TGV, obstruction of the aortic arch, truncus arteriosus, atrioventricular duct, pulmonary atresia with or without communication inter ventricular.
• • Informed consent signed by both parents
• • Patient affiliated to health social security
• Non-inclusion criteria:
• • patients with a birth weight less than 2 kilograms and / or a gestational age less than 37 weeks
• • patients with a CCHD not requiring cardiac surgery with extra-corporeal circulation in the first 2 months of life
• • patients with a chromosomal abnormality or genetic syndrome proven associated with CCHD