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Implantation of Total Artificial Heart in Congenital Heart Disease
Published on: July 18, 2014
Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart
I Ribera1, A Ruiz1, O Sánchez1,2
1Department of Obstetrics, Vall d'Hebron University Hospital, Universitat Autònoma De Barcelona, Barcelona, Spain.
Insights
This study investigates neurodevelopmental outcomes in infants with congenital heart disease (CHD). It aims to improve prognostic tools and preventive strategies for better long-term health in children with CHD.
Area of Science:
- Pediatric Cardiology
- Neurodevelopmental Pediatrics
- Fetal Medicine
Background:
- Congenital heart disease (CHD) affects 1 in 100 newborns, with increased survival rates.
- Long-term neurodevelopmental disabilities are a significant concern in children with CHD.
- Early identification of neurodevelopmental risks is crucial for pregnancy counseling.
Purpose of the Study:
- To comprehensively assess the neurologic prognosis of children with CHD.
- To establish a detailed understanding of neurodevelopmental trajectories in infants with severe CHD.
- To develop clinical tools for improved prediction and prevention strategies.
Main Methods:
- Prospective study of pregnant women (20-37 weeks gestation) carrying fetuses with CHD.
- Multimodal data collection: fetal/maternal hemodynamics, fetal MRI, echocardiography, EEG, biomarkers.
- Neurodevelopmental assessments at 12 (ASQ) and 24 months (Bayley-III).
- Recruitment of at least 150 cases across three main CHD groups: TGA, TOF, LVOTO.
Main Results:
- Data collection ongoing from fetal period to 24 months of age.
- Detailed analysis of neurodevelopmental outcomes in relation to specific CHD types.
- Correlation of various hemodynamic and imaging parameters with neurodevelopmental status.
Conclusions:
- The NEURO-HEART study will provide extensive data on neurodevelopmental outcomes in CHD.
- Findings will inform the development of predictive clinical tools.
- Results aim to enhance preventive strategies for neurodevelopmental deficits in CHD patients.
Background:
Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns. While advances in early diagnosis and postnatal management have increased survival in CHD children, worrying long-term outcomes, particularly neurodevelopmental disability, have emerged as a key prognostic factor in the counseling of these pregnancies.
Methods:
Eligible participants are women presenting at 20 to < 37 weeks of gestation carrying a fetus with CHD. Maternal/neonatal recordings are performed at regular intervals, from the fetal period to 24 months of age, and include: placental and fetal hemodynamics, fetal brain magnetic resonance imaging (MRI), functional echocardiography, cerebral oxymetry, electroencephalography and serum neurological and cardiac biomarkers. Neurodevelopmental assessment is planned at 12 months of age using the ages and stages questionnaire (ASQ) and at 24 months of age with the Bayley-III test. Target recruitment is at least 150 cases classified in three groups according to three main severe CHD groups: transposition of great arteries (TGA), Tetralogy of Fallot (TOF) and Left Ventricular Outflow Tract Obstruction (LVOTO).
Discussion:
The results of NEURO-HEART study will provide the most comprehensive knowledge until date of children's neurologic prognosis in CHD and will have the potential for developing future clinical decisive tools and improving preventive strategies in CHD.
Trial Registration:
NCT02996630 , on 4th December 2016 (retrospectively registered).
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