Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733378
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2021-01-27
Brief Title:
Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CINC
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 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
Detailed Description:
Congenital heart disease is the most frequent congenital malformation and concerns 9 newborns per 1000 live births ie nearly 1 of births Half of these children present a complex form of congenital heart disease requiring surgery during the first months of life More than one child in two will present a neurodevelopmental disorder resulting from brain damage beginning in utero and continuing in the post-natal period In the newborn with complex congenital heart disease CCHD cerebral immaturity is synonymous with vulnerability leading in half of the cases to the perioperative occurrence of hypoxic-ischemic cerebral lesions most of which affect the white matter These white matter injuries WMI are a prognostic factor for motor cognitive language and behavioural disorders that induce psycho-social difficulties in adulthood altering the quality of life of patients In newborns with CCHD Transposition of Great Arteries or Left Ventricular Hypoplasia operated on later in the neonatal period both the incidence of perioperative BSL and post-operative morbidity are increased
Earlier surgery may therefore be a neuroprotective strategy leading to a reduction in perioperative WMI postoperative morbidity and a better neurodevelopmental prognosis in infants with CCHD
The investigators 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 the investigators planned to 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
Recruitment will be performed in a prospective cohort n50 of neonates with CCHD requiring surgery during the first 2 months of life and benefiting from pre- and post-operative cerebral MRI standardized neurological examinations at 4 12 24 months and neuropsychological evaluation with a Bayley III test at 24 months
Earlier surgery may therefore be a neuroprotective strategy leading to a reduction in perioperative WMI postoperative morbidity and a better neurodevelopmental prognosis in infants with CCHD
The investigators 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 the investigators planned to 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
Recruitment will be performed in a prospective cohort n50 of neonates with CCHD requiring surgery during the first 2 months of life and benefiting from pre- and post-operative cerebral MRI standardized neurological examinations at 4 12 24 months and neuropsychological evaluation with a Bayley III test at 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A00369-30 | OTHER | ANSM | None |