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

NCT ID: NCT04733378

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-24
• Study Completion Date: 2025-12-24

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.

Conditions

Complex Congenital Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Peri-operative neurological monitoring

Group Type: EXPERIMENTAL

Peri-operative neurological monitoring

Intervention Type: PROCEDURE

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.

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.

Intervention Type: PROCEDURE

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

• 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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice DESNOUS, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique-Hôpitaux de Marseille

Locations

Assistance Publique Des Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emilie GARRIDO-PRADALIE, Reasearch Director

Role: CONTACT

drci@ap-hm.fr

0491382747 ext. +33

Facility Contacts

Emilie GARRIDO-PRADALIE

Role: primary

drci@ap-hm.fr

+33 (0)4 91 38 27 47

Béatrice DESNOUS

Role: backup

beatrice.desnous@ap-hm.fr

Other Identifiers

2020-A00369-30

Identifier Type: OTHER

Identifier Source: secondary_id

2019-44

Identifier Type: -

Identifier Source: org_study_id