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Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
Sponsor: Assistance Publique Hopitaux De Marseille
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 with CCHD. Secondly, we will study the relationship between age at surgery and (i) the incidence of WMI observed on pre- and post-operative cerebral MRI (ii) post-operative morbidity as defined by the occurrence of post-operative complications (haemodynamic, infectious, neurological, surgical) and (iii) the length of hospital stay.
Key Details
Gender
All
Age Range
0 Months - 2 Months
Study Type
INTERVENTIONAL
Enrollment
49
Start Date
2021-12-24
Completion Date
2025-12-15
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Peri-operative neurological monitoring
Pre- and post-operative cerebral MRI, standardized neurological examinations at 4, 12, 24 months and neuropsychological evaluation with a Bayley III test (Bayley Scale of Infant and Toddler Development, Third Edition) at 24 months.
Locations (1)
Assistance Publique Des Hopitaux de Marseille
Marseille, France