Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol
Por:
Ribera, I, Ruiz, A, Sanchez, O, Eixarch, E, Antolin, E, Gomez-Montes, E, Perez-Cruz, M, Cruz-Lemini, M, Sanz-Cortes, M, Arevalo, S, Ferrer, Q, Vazquez, E, Vega, L, Dolader, P, Montoliu, A, Boix, H, Simoes, RV, Masoller, N, Sanchez-de-Toledoll, J, Comas, M, Bartha, JM, Galindo, A, Martinez, JM, Gomez-Roig, L, Crispi, F, Gomez, O, Carreras, E, Caberol, L, Gratacos, E, Llurba, E
Publicada:
10 sep 2019
Resumen:
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.
Filiaciones:
Ribera, I:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Obstet, Barcelona, Spain
Ruiz, A:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Obstet, Barcelona, Spain
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
Sanchez, O:
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Eixarch, E:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Obstet, Barcelona, Spain
Antolin, E:
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
Hosp Univ La Paz, Dept Obstet & Gynaecol, Div Maternal & Fetal Med, Madrid, Spain
Gomez-Montes, E:
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
Univ Computense Madrid, Hosp Univ 12 Octubre, Madrid, Spain
Perez-Cruz, M:
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Cruz-Lemini, M:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Obstet, Barcelona, Spain
Sanz-Cortes, M:
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Arevalo, S:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Obstet, Barcelona, Spain
Ferrer, Q:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Paediat Cardiol, Barcelona, Spain
Vazquez, E:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Pediat Radiol, Barcelona, Spain
Vega, L:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Paediat Cardiol, Barcelona, Spain
Dolader, P:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Paediat Cardiol, Barcelona, Spain
Montoliu, A:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Neuropsicol, Barcelona, Spain
Boix, H:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Pediat, Barcelona, Spain
Simoes, RV:
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Masoller, N:
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Sanchez-de-Toledoll, J:
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
Hosp St Joan de Deu, Dept Cardiol, Barcelona, Spain
Comas, M:
Univ Hosp Germans Trias & Pujol, Barcelona, Spain
Bartha, JM:
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
Hosp Univ La Paz, Dept Obstet & Gynaecol, Div Maternal & Fetal Med, Madrid, Spain
Galindo, A:
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
Univ Computense Madrid, Hosp Univ 12 Octubre, Madrid, Spain
Martinez, JM:
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Gomez-Roig, L:
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Crispi, F:
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Gomez, O:
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Carreras, E:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Obstet, Barcelona, Spain
Caberol, L:
Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Dept Obstet, Barcelona, Spain
Gratacos, E:
Hosp Clin Barcelona, BCNatal, Barcelona, Spain
Hosp St Joan de Deu, Barcelona, Spain
Llurba, E:
ISCIII Sub Directorate Gen Res Assessment & Promo, Spain Maternal & Child Hlth Dev Network, Madrid, Spain
ERDF, Madrid, Spain
St Creu & St Pau Hosp, Obstet & Gynaecol Dept, St Antoni Ma Claret 167, Barcelona 08025, Spain
Gold, Green Published
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