Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
- Conditions
- Complex Congenital Heart Disease
- Interventions
- Procedure: Peri-operative neurological monitoring
- Registration Number
- NCT04733378
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- 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, i.e. 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 (n=50) 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Peri-operative neurological monitoring Peri-operative neurological monitoring -
- Primary Outcome Measures
Name Time Method Measurement of the association between age at surgery (days of life) and scores (mean = 100, standard deviation = 15) obtained on the Bayley II test 12 months Measurement of the association between age at surgery (days of life) and scores (mean = 100, standard deviation = 15) obtained on the Bayley II test for each subtest: motor, cognitive and language. This association will be evaluated by a correlation coefficient
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Assistance Publique Des Hopitaux de Marseille
🇫🇷Marseille, France