Status:
RECRUITING
Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Complex Congenital Heart Disease
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
We propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients ...
Detailed Description
Congenital heart disease is the most frequent congenital malformation and concerns 9 newborns per 1000 live births, i.e. nearly 1% of births. Half of these children present a complex form of congenita...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04733378
Start Date
December 24 2021
End Date
December 24 2025
Last Update
January 8 2024
Active Locations (1)
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1
Assistance Publique Des Hopitaux de Marseille
Marseille, France, 13354